Gastric CancerPhase 2NCT06313801
Comparing the Safety and Efficacy of First-line Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions
A Phase 2 study testing Docetaxel, Oxaliplatin and Calcium folinate in people with Gastric Cancer, run by Nizhny Novgorod Regional Clinical Oncology Center at 1 site in Russia.
Trial summary
After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Docetaxel, Oxaliplatin and Calcium folinate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteRussia
- Study dates
- 19 Jan 2023to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability of signed informed voluntary consent of the patient
- Age ≥18 years and ≤75 years
- ECOG ≤1
- Histological verification of gastric cancer and esophageal-gastric junction Siewert III (adenocarcinoma, ring-cell carcinoma)
- Her2-neu negative tumor status
- The presence of a preserved informative block of the primary tumor in the histological archive of the NOCOD (performing a biopsy and/or providing archival material - with the consent of the patient)
Show all 11Show fewer
- Verified gastric cancer (adenocarcinoma, ring-cell carcinoma) with the presence of M1 (with the only manifestation of M1 in the form of - Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI <16)
- Peritoneal adhesion index PAI <16
- Absence of active infectious, mental diseases, pronounced allergic conditions, as well as other concomitant pathology that may interfere with the implementation of the therapeutic and diagnostic measures provided for in the protocol
- Adequate organ function (evaluation by laboratory parameters at screening - evaluation of hemoglobin, neutrophils, platelets, AST, ALT, total bilirubin, urea, creatinine)
- Consent of men and women with preserved childbearing potential to use highly effective methods of contraception.
Who cannot join
- Lack of informed voluntary consent of the patient
- Age <18 years and >75 years
- ECOG ≥2
- Histological forms other than adenocarcinoma and ring-cell carcinoma of the stomach and esophageal-gastric junction Siewert III
- Her2-neu positive tumor status
- The absence of a preserved informative block of the primary tumor in the histological archive of the NOCOD
Show all 16Show fewer
- M1 with the exception of Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI <16 (Distant metastases, including mts in supraclavicular, mediastinal, paraaortic (16 collector), ovarian metastases. Note - MTS in peripheral lymph nodes require a fine needle puncture with cytological examination for verification. In case of mts lesions of intracorporeal lymph nodes, the criteria of mts will be - dimensions of more than 15 mm along the short axis or mts-altered structure of the lymph node, regardless of size; PCI ≥16)
- Peritoneal adhesion index PAI ≥16
- Contraindications to performing diagnostic laparoscopy
- Complicated primary tumor (bleeding, decompensated stenosis, dysphagia III-IV) if not corrected.
- Decompensated concomitant pathology
- Primary multiple tumors (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease)
- Any specific antitumor treatment for stomach cancer and /or other malignant tumor in the anamnesis (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease)
- Previous specialized treatment for stomach cancer
- Known individual intolerance to drugs included in the protocol
- Pregnancy, breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", 11/1, Delovaya street, Nizhny Novgorod, 603126
Nizhny Novgorod, 603126
Sergey Klimin, +79875403280, kliminsergey7@gmail.com
About this study
Official title: The Single-center Randomized Study "Comparison of Safety and Effectiveness of the First Line of Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions in Primary Gastric Cancer With Isolated Peritoneal Carcinomatosis.
After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
Read the detailed description
Signing the informed consent to participate in the study. All the patients with suspected peritoneal carcinomatosis (according to the results of radiation diagnostics, as well as confirmed peritoneal carcinomatosis by puncture biopsy or by taking ascitic fluid) undergo diagnostic laparoscopy at the first stage. In addition, screening will include all the patients with locally advanced gastric cancer undergoing laparoscopy prior to planning combination treatment. If they have foci of carcinomatosis in the peritoneum PCI up to 15 inclusive and/or Cy+ (as the only manifestation of M1), the patients of this group can be included in the study. The methodology for performing diagnostic laparoscopy is described below (excluding dPIPAC components). Note - the examination of the omental bursa as part of diagnostic laparoscopy is optional, depending on the clinical situation. Screening and examination of patients according to current clinical guidelines for nosology stomach cancer taking into account the examination criteria specified in this protocol. Performing initial diagnostic laparoscopy at the stationary stage according to the standard procedure (described above). If carcinomatosis is detected the evaluation of PCI is carried out by Sugarbaker. The patient randomization based on positive (Cy+) abdominal flushing and/or peritoneal dissemination with PCI index <16. The randomization will be carried out using an Internet resource https://www.sealedenvelope.com. Taking into account the planned set and heterogeneity of the groups, the patients will be stratified before randomization according to the following factors: microscopic carcinomatosis of Cy+ only, macroscopic carcinomatosis PCI up to 7 inclusive, macroscopic carcinomatosis PCI from 8 to 15 inclusive; accordingly, the patients within the strata will be randomized separately.
The Control group (the group No 1). Within 1-4 weeks after the initial diagnostic laparoscopy the group No 1 patients start polychemotherapy courses according to the FLOT scheme in the amount of 6 (six); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy for no more than 2 weeks with no obvious signs of progression (in this case, the patient switches to the 2nd line of chemotherapy). The evaluation of the therapeutic pathomorphosis of foci in the peritoneum is carried out according to the PRGS system (Peritoneal Regression Grading Score). As the result of the treatment: in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, after the completion of the planned treatment, the patients switch to the dynamic observation or cytoreductive surgery is considered within 1 month after the completion of polychemotherapy (optionally, by decision of the local council); in case of the incomplete response (due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST), the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy (the scheme at the discretion of the attending physician) or the optimal palliative care options depending on the clinical situation is considered; accordingly the patient completes the therapy proposed by the study. The response criteria are specified separately. Shifting the timing of chemotherapy up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study.
The Study group (the group No 2). Within 1-4 weeks after the initial diagnostic laparoscopy the group No 2 patients start polychemotherapy courses according to the scheme FLOT (the 1st , the 3rd, the 5th courses) and mFLOT (the 2nd, the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with with dPIPAC sessions using docetaxel the examination is carried out every 3 courses (after the 3rd and 6th) with the performance of dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy (all the procedures are performed according to the method described in the protocol; the evaluation of the therapeutic pathomorphosis of lesions in the peritoneum is carried out according to the PRGS system (Peritoneal Regression Grading Score)). Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the group No 1. As the result of the treatment: in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, after the completion of the planned treatment, the patients switch to the dynamic observation or cytoreductive surgery is considered after the completion of polychemotherapy (optionally, by decision of the local council); in case of the incomplete response (due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST), the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy (the scheme at the discretion of the attending physician) or the optimal palliative care options depending on the clinical situation is considered; accordingly the patient completes the therapy proposed by the study. The method of performing the surgical manual is specified separately. The response criteria are specified separately. Shifting the timing of chemotherapy with dPIPAC sessions up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study.
- Conditions
- Gastric Cancer
- Being tested
- Docetaxel, Oxaliplatin, Calcium folinate, Fluorouracil, Diagnostic laparoscopy
- Keywords
- FLOT, mFLOT, dPIPAC, PIPAC
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel 50 mg/m2 intravenously on day 1
OxaliplatinDrug
Oxaliplatin 85 mg/m2 on Day 1
Calcium folinateDrug
200 mg/m2 2-hour intravenous infusion on day 1
FluorouracilDrug
2600 mg/m2 x intravenous infusion 24-hours (infusion of the samee of the total dose of fluorouracil for 48 hours) on day 1.
Diagnostic laparoscopyProcedure or surgery
Access to the abdominal cavity by Hassen (3 trocars). Carboxyperitoneum - 12 mm of water column - stable pressure maintenance throughout the operation. Revision. Photo recording of 4 quadrants of the abdominal cavity from the paraumbilical port. The evaluation of the PCI index. The evaluation of other distant dissemination. Standard peritoneal lavage of 300 ml Sol. NaCl 0.9 % (37 ºС), with the exposure of 3-5 minutes (with Trendelenburg and Fowler position alternately) and the lavage aspiration, the transfer of the lavage for the cytological examination. Biopsy of perioneal lessions if needed.The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds.
dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)).Combination product
Diagnostic laparoscopy described earlier and PIPAC session. The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml. The rate of administration is 30 ml per minute. The maximum pressure in the injector system is 250 PSI. After the spray stage, the exposure is 30 minutes while maintaining the declared intraperitoneal pressure. After the exposure stage, only gas is removed from the abdominal cavity. The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | FLOT: Docetaxel 50 mg/m2 intravenously on day 1 + Oxaliplatin 85 mg/m2 intravenously on day 1 + Calcium folinate 200 mg/m2 2-hour intravenous infusion on day 1 + fluorouracil 2600 mg/m2 x intravenous infusion 24-hours (infusion of the same of the total dose of fluorouracil for 48 hours) on day 1. Repeat every 2 weeks. 6 courses. Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: Fluorouracil; Procedure: Diagnostic laparoscopy |
| Study group | Experimental | mFLOT: Oxaliplatin 85 mg/m2 intravenously on day 1 + Calcium folinate 200 mg/m2 2-hour intravenous infusion on day 1 + fluorouracil 2600 mg/m2 x intravenous infusion 24-hours (infusion of the same of the total dose of fluorouracil for 48 hours) on day 1. Repeat every 2 weeks. 6 courses.
+ The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml (intraperitoneal pressurized infusion). Receives: Drug: Oxaliplatin; Drug: Calcium folinate; Drug: Fluorouracil; Procedure: Diagnostic laparoscopy; Combination Product: dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progression-free survival.
Time interval from randomization to progression of disease, death from any cause or date of last observation in the absence of these events. In months with an accuracy of 0.1. (Time Frame: 4 years 6 months)
Measured: 4 years 6 months
Complications from polychemotherapy.
Complications from polychemotherapy (including intraperitoneal administration), evaluated according to СТСАЕ v5.0. The proportion of patients with any adverse events; the proportion of patients with grade 3-5 adverse events; the proportion of patients with complications in qualitative terms (for example: hematological, gastrointestinal, etc.). (Time Frame: 3 years 6 months)
Measured: 3 years 6 months
Secondary outcomes (5)
The overall survival.
Time interval from randomization to death from any cause or date of last observation in the absence of these events. In months with an accuracy of 0.1. (Time Frame: 4 years 6 months)
Measured: 4 years 6 months
The completeness of the planned therapy.
The proportion of patients who received all the therapy planned in the study in each group. (Time Frame: 3 years 6 months)
Measured: 3 years 6 months
Percentage of patient conversions to Су- and PCI- rate.
The proportion of patients conversions to Су- and PCI- rate (Time Frame: 3 years 6 months)
Measured: 3 years 6 months
Surgical complications of operated patients
Surgical complications of operated patients (the evaluation by Clavien-Dindo classification) (the proportion of patients with surgical complications IIIb-V grade). (Time Frame: 3 years 6 months)
Measured: 3 years 6 months
Аssessment of the quality of life
Quality of life assessment by European Organisation for Research and Treatment of Cancer scale (unabbreviated scale title) Quality of Life Questionnaire - Core 30 (QLQ-C30) by Scoring of the QLQ-C30 Summary Score using the descriptive analysis with the qlqc30 command (detailed description in manual ISBN 2-9300 64-22-6). The minimum values of general health score are mean a worse outcome (minimum score 0), the maximum values of general health score are mean a better outcome (maximum score 100). (Time Frame: 4 years)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start19 Jan 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the control group, after diagnostic laparoscopy, 6 courses of PCT FLOT are carried out, examination every 3 courses with the performance of control diagnostic laparoscopy after 6 courses of PCT. In the study group, after diagnostic laparoscopy, FLOT PCT courses (1st, 3rd, 5th courses), mFLOT (2nd, 4th, 6th courses) are conducted, examination every 3 courses with dPIPAC sessions with docetaxel (excluding it from systemic administration) on the 2nd, 4th, 6th courses of PCT. In group 2, the function of control laparoscopy is performed by revision at the dPIPAC session of the 6th course of PCT. In both groups, with complete regression of foci along the peritoneum and Cy- in peritoneal lavage - dynamic observation or cytoreductive surgery, with incomplete response - dynamic observation before progression, with progression - the 2nd line of CT or optimal palliative care options.
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Gamayunov, DMS, Study director, Chief oncology specialist in the region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313801
- Sponsor's protocol ID
- DPNCD-2309
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single-center Randomized Study "Comparison of Safety and Effectiveness of the First Line of Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions in Primary Gastric Cancer With Isolated Peritoneal Carcinomatosis.
- ClinicalTrials.gov ID
- NCT06313801
- Acronym / sponsor ID
- DPNCD-2309
- Conditions
- Gastric Cancer
- Keywords
- FLOT, mFLOT, dPIPAC, PIPAC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Nizhny Novgorod Regional Clinical Oncology CenterOther government
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After the initial diagnostic laparoscopy the Control group patients undergo 6 courses of polychemotherapy according to the FLOT scheme; the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
After the initial diagnostic laparoscopy the Study group patients undergo courses of polychemotherapy according to the scheme FLOT (the 1st, the 3rd, the 5th courses) and mFLOT (the 2nd , the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy. Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the Control group. In the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, the dynamic observation or cytoreductive surgery is considered (optionally); in case of the incomplete response the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy or the optimal palliative care options depending on the clinical situation is considered.
Detailed description
Signing the informed consent to participate in the study. All the patients with suspected peritoneal carcinomatosis (according to the results of radiation diagnostics, as well as confirmed peritoneal carcinomatosis by puncture biopsy or by taking ascitic fluid) undergo diagnostic laparoscopy at the first stage. In addition, screening will include all the patients with locally advanced gastric cancer undergoing laparoscopy prior to planning combination treatment. If they have foci of carcinomatosis in the peritoneum PCI up to 15 inclusive and/or Cy+ (as the only manifestation of M1), the patients of this group can be included in the study. The methodology for performing diagnostic laparoscopy is described below (excluding dPIPAC components). Note - the examination of the omental bursa as part of diagnostic laparoscopy is optional, depending on the clinical situation. Screening and examination of patients according to current clinical guidelines for nosology stomach cancer taking into account the examination criteria specified in this protocol. Performing initial diagnostic laparoscopy at the stationary stage according to the standard procedure (described above). If carcinomatosis is detected the evaluation of PCI is carried out by Sugarbaker. The patient randomization based on positive (Cy+) abdominal flushing and/or peritoneal dissemination with PCI index <16. The randomization will be carried out using an Internet resource https://www.sealedenvelope.com. Taking into account the planned set and heterogeneity of the groups, the patients will be stratified before randomization according to the following factors: microscopic carcinomatosis of Cy+ only, macroscopic carcinomatosis PCI up to 7 inclusive, macroscopic carcinomatosis PCI from 8 to 15 inclusive; accordingly, the patients within the strata will be randomized separately.
The Control group (the group No 1). Within 1-4 weeks after the initial diagnostic laparoscopy the group No 1 patients start polychemotherapy courses according to the FLOT scheme in the amount of 6 (six); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with the control diagnostic laparoscopy after 6 courses of polychemotherapy for no more than 2 weeks with no obvious signs of progression (in this case, the patient switches to the 2nd line of chemotherapy). The evaluation of the therapeutic pathomorphosis of foci in the peritoneum is carried out according to the PRGS system (Peritoneal Regression Grading Score). As the result of the treatment: in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, after the completion of the planned treatment, the patients switch to the dynamic observation or cytoreductive surgery is considered within 1 month after the completion of polychemotherapy (optionally, by decision of the local council); in case of the incomplete response (due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST), the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy (the scheme at the discretion of the attending physician) or the optimal palliative care options depending on the clinical situation is considered; accordingly the patient completes the therapy proposed by the study. The response criteria are specified separately. Shifting the timing of chemotherapy up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study.
The Study group (the group No 2). Within 1-4 weeks after the initial diagnostic laparoscopy the group No 2 patients start polychemotherapy courses according to the scheme FLOT (the 1st , the 3rd, the 5th courses) and mFLOT (the 2nd, the 4th, the 6th courses) in the amount of 6 (six, 3+3); the examination is carried out every 3 courses (after the 3rd and the 6th courses) with with dPIPAC sessions using docetaxel the examination is carried out every 3 courses (after the 3rd and 6th) with the performance of dPIPAC sessions using docetaxel (thus excluding it from the system administration) in the 2nd , the 4th, the 6th courses of polychemotherapy (all the procedures are performed according to the method described in the protocol; the evaluation of the therapeutic pathomorphosis of lesions in the peritoneum is carried out according to the PRGS system (Peritoneal Regression Grading Score)). Control diagnostic laparoscopy is not performed in the group No 2, its function is performed by the revision at the PIPAC session of the 6th course of polychemotherapy, which corresponds to the time interval of the group No 1. As the result of the treatment: in the event of the complete regression of foci along the peritoneum and receiving Cy- in the peritoneal lavage, after the completion of the planned treatment, the patients switch to the dynamic observation or cytoreductive surgery is considered after the completion of polychemotherapy (optionally, by decision of the local council); in case of the incomplete response (due to the immeasurable characteristics of the tumor and the impossibility of evaluation by RECIST), the dynamic observation is carried out until progression; in case of progression the 2nd line of chemotherapy (the scheme at the discretion of the attending physician) or the optimal palliative care options depending on the clinical situation is considered; accordingly the patient completes the therapy proposed by the study. The method of performing the surgical manual is specified separately. The response criteria are specified separately. Shifting the timing of chemotherapy with dPIPAC sessions up to 10 days and the timing of control examinations up to 10 days due to objective circumstances is considered acceptable within the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the control group, after diagnostic laparoscopy, 6 courses of PCT FLOT are carried out, examination every 3 courses with the performance of control diagnostic laparoscopy after 6 courses of PCT. In the study group, after diagnostic laparoscopy, FLOT PCT courses (1st, 3rd, 5th courses), mFLOT (2nd, 4th, 6th courses) are conducted, examination every 3 courses with dPIPAC sessions with docetaxel (excluding it from systemic administration) on the 2nd, 4th, 6th courses of PCT. In group 2, the function of control laparoscopy is performed by revision at the dPIPAC session of the 6th course of PCT. In both groups, with complete regression of foci along the peritoneum and Cy- in peritoneal lavage - dynamic observation or cytoreductive surgery, with incomplete response - dynamic observation before progression, with progression - the 2nd line of CT or optimal palliative care options.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Docetaxel, Drug: Oxaliplatin, Drug: Calcium folinate, Drug: Fluorouracil, Procedure: Diagnostic laparoscopyFLOT: Docetaxel 50 mg/m2 intravenously on day 1 + Oxaliplatin 85 mg/m2 intravenously on day 1 + Calcium folinate 200 mg/m2 2-hour intravenous infusion on day 1 + fluorouracil 2600 mg/m2 x intravenous infusion 24-hours (infusion of the same of the total dose of fluorouracil for 48 hours) on day 1. Repeat every 2 weeks. 6 courses. |
| Study group | Experimental | Drug: Oxaliplatin, Drug: Calcium folinate, Drug: Fluorouracil, Procedure: Diagnostic laparoscopy, Combination Product: dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)).mFLOT: Oxaliplatin 85 mg/m2 intravenously on day 1 + Calcium folinate 200 mg/m2 2-hour intravenous infusion on day 1 + fluorouracil 2600 mg/m2 x intravenous infusion 24-hours (infusion of the same of the total dose of fluorouracil for 48 hours) on day 1. Repeat every 2 weeks. 6 courses. + The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml (intraperitoneal pressurized infusion). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Availability of signed informed voluntary consent of the patient
- Age ≥18 years and ≤75 years
- ECOG ≤1
- Histological verification of gastric cancer and esophageal-gastric junction Siewert III (adenocarcinoma, ring-cell carcinoma)
- Her2-neu negative tumor status
Key exclusion criteria (16 listed)
- Lack of informed voluntary consent of the patient
- Age <18 years and >75 years
- ECOG ≥2
- Histological forms other than adenocarcinoma and ring-cell carcinoma of the stomach and esophageal-gastric junction Siewert III
- Her2-neu positive tumor status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel 50 mg/m2 intravenously on day 1 | Drug | Control group |
| OxaliplatinOxaliplatin 85 mg/m2 on Day 1 | Drug | Control group, Study group |
| Calcium folinate200 mg/m2 2-hour intravenous infusion on day 1 | Drug | Control group, Study group |
| Fluorouracil2600 mg/m2 x intravenous infusion 24-hours (infusion of the samee of the total dose of fluorouracil for 48 hours) on day 1. | Drug | Control group, Study group |
| Diagnostic laparoscopyAccess to the abdominal cavity by Hassen (3 trocars). Carboxyperitoneum - 12 mm of water column - stable pressure maintenance throughout the operation. Revision. Photo recording of 4 quadrants of the abdominal cavity from the paraumbilical port. The evaluation of the PCI index. The evaluation of other distant dissemination. Standard peritoneal lavage of 300 ml Sol. NaCl 0.9 % (37 ºС), with the exposure of 3-5 minutes (with Trendelenburg and Fowler position alternately) and the lavage aspiration, the transfer of the lavage for the cytological examination. Biopsy of perioneal lessions if needed.The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds. | Procedure or surgery | Control group, Study group |
| dPIPAC ( The description of the standard diagnostic laparoscopy procedure and the session of PIPAC (dPIPAC)).Diagnostic laparoscopy described earlier and PIPAC session. The drugs for PIPAC - Docetaxel 50 mg/ m2 diluted with saline sodium chloride to a total volume of 200 ml. The rate of administration is 30 ml per minute. The maximum pressure in the injector system is 250 PSI. After the spray stage, the exposure is 30 minutes while maintaining the declared intraperitoneal pressure. After the exposure stage, only gas is removed from the abdominal cavity. The operation is completed as standard with the extraction of laparoports and suturing of laparoport wounds. | Combination product | Study group |
Primary outcome
The progression-free survival.
Time frame: 4 years 6 months
Time interval from randomization to progression of disease, death from any cause or date of last observation in the absence of these events. In months with an accuracy of 0.1. (Time Frame: 4 years 6 months)
Complications from polychemotherapy.
Time frame: 3 years 6 months
Complications from polychemotherapy (including intraperitoneal administration), evaluated according to СТСАЕ v5.0. The proportion of patients with any adverse events; the proportion of patients with grade 3-5 adverse events; the proportion of patients with complications in qualitative terms (for example: hematological, gastrointestinal, etc.). (Time Frame: 3 years 6 months)
5 secondary outcomes
The overall survival.
Time frame: 4 years 6 months
The completeness of the planned therapy.
Time frame: 3 years 6 months
Percentage of patient conversions to Су- and PCI- rate.
Time frame: 3 years 6 months
Surgical complications of operated patients
Time frame: 3 years 6 months
Аssessment of the quality of life
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergey Gamayunov, DMS study director
Chief oncology specialist in the region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Oxaliplatin and Calcium folinate in people with Gastric Cancer, run by Nizhny Novgorod Regional Clinical Oncology Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Klimin (+79875403280, kliminsergey7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression-free survival. (time frame: 4 years 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.