Peritoneal CarcinomatosisGASPACCONCT04595929
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-
A study testing Staging laparoscopy, 5-Fluorouracil and Leucovorin in people with Peritoneal Carcinomatosis and Gastric Cancer, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peritoneal Carcinomatosis, Gastric Cancer
- What is being tested?
- Staging laparoscopy, 5-Fluorouracil and Leucovorin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteRussia
- Study dates
- 10 Feb 2020to 10 Jan 2029
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0).
- No preceding cytotoxic or targeted therapy.
- No prior partial or complete tumor resection.
- Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.
- highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
- ECOG = 0-2.
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- Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI.
- Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy
- Adequate hematological, hepatic and renal function parameters:
- Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL Serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of normal, alkaline phosphatase ≤ 6 x upper limit of normal For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant regimen.
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.
Who cannot join
- Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT.
- Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel.
- Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel.
- Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV.
- Clinically significant valvular defect.
- Criteria of primary unresectability, e.g.:
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- Radiologically documented evidence of major blood vessel invasion or invasion of adjacent organs (T4b).
- Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!).
- Other severe internal disease or acute infection.
- Peripheral polyneuropathy ≥ NCI Grade II.
- Patient has undergone major surgery within 28 days prior to enrollment except staging laparoscopy.
- Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.
- On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study.
- Patient pregnant or breast feeding, or planning to become pregnant.
- Any other concurrent antineoplastic treatment including irradiation.
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
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197101
Ilya Vervekin, 89119695285, iivervekin@yandex.ru
Michael Belyaev, PhD
About this study
Official title: Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.
Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.
Read the detailed description
The study is interventional: patients over 18 years of age with an established diagnosis of stomach cancer (c)T3-4N0-3M0 CYT- will be randomized into 2 groups using the envelope method. The control group will receive only neoadjuvant chemotherapy + gastrectomy/ distal subtotal resection with D2 lymph node dissection, the active comparison group - neoadjuvant chemotherapy + gastrectomy with D2 lymph node dissection + PIPAC (Cisplatin (7.5 mg / m²) + Doxirubicin 1.5 mg / m2)). Will be assessed: overall survival, median survival, disease-free survival, quality of life of patients.
- Conditions
- Peritoneal Carcinomatosis, Gastric Cancer
- Being tested
- Staging laparoscopy, 5-Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel
- Keywords
- Gastric cancer, Aerosol Chemotherapy, Regional Chemotherapy, Peritoneal Carcinomatosis, Peritoneal washings, Intraperitoneal chemotherapy
- Medical subject headings
- Peritoneal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staging laparoscopyProcedure or surgery
All patients undergo staging laparoscopy and peritoneal lavage.
5-FluorouracilDrug
Also called 5-FU
Day 1 q2w: 2600 mg/m² IV over 24 hours
LeucovorinDrug
Also called Calciumfolinat
Day 1 q2w: 200 mg/m² IV over 30 minutes
OxaliplatinDrug
Day 1 q2w: 85 mg/m² IV over 2 hours
DocetaxelDrug
Day 1 q2w: 50 mg/m² IV over 1 hour
Radical surgeryProcedure or surgery
Radical gastrectomy with D2 - lymph node dissection.
PIPACProcedure or surgery
Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².
Adjuvant chemotherapyDrug
Adjuvant chemotherapy according to indications.
| Study group | Role | What they receive |
|---|---|---|
| PIPAC group | Experimental | 1. Staging laparoscopy + peritoneal lavage.
2. 4 cycles of neoadjuvant chemotherapy: FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m² every 2 weeks.
3. Radical gastrectomy with D2 - lymph node dissection.
4. Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².
5. Adjuvant chemotherapy according to indications. Receives: Procedure: Staging laparoscopy; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel; Procedure: Radical surgery; Procedure: PIPAC; Drug: Adjuvant chemotherapy |
| Control group | Active comparator | 1. Staging laparoscopy + peritoneal lavage.
2. 4 cycles of neoadjuvant chemotherapy: FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m² every 2 weeks.
3. Radical gastrectomy with D2 - lymph node dissection.
4. Adjuvant chemotherapy according to indications. Receives: Procedure: Staging laparoscopy; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Docetaxel; Procedure: Radical surgery; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Overall survival (OS) in both arms
Overall survival (OS) where OS is defined as the time from randomization to death from any cause.
Measured: from randomization up to 5 years
Secondary outcomes (8)
Comparison of Overall survival rates at 3 and 5 years in both arms
Overall survival rates at 3 \& 5 years defined as the percentage patients known to be alive after 3 and 5 years referring to the total number of patients randomized into the respective treatment arm
Measured: 3 and 5 years after randomization
Comparison of progression-/disease-free survival (PFS/DFS) between arms
PFS/DFS is defined as the time from randomization to disease progression or relapse after surgery or death from any cause.
Measured: from randomization up to 5 years
Comparison of peritoneal relapse rate in both arms
Peritoneal relapse rate defined as the percentage of patients with peritoneal relapse referring to the total number of patients randomized into the respective treatment arm
Measured: from randomization up to 5 years
PFS/DFS rates at 2, 3 & 5 years
PFS/DFS rates at 2, 3 \& 5 years defined as the percentage of patients without disease progression or relapse after surgery or death from any cause after 2, 3 and 5 years referring to the total number of patients randomized into the respective treatment arm
Measured: 2, 3 & 5 years after randomization
Rate of surgical serious adverse events (SAEs)
Rate of surgical serious adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0) grade ≥ 3 adverse events and grade ≥ 3 laboratory toxicities.
Measured: After randomization of the patient until 30 days after last study-specific treatment
Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment. Questionnaires given to the patients (validated quality of life questionnaires EORTC QLQ C30).
EORTC QLQ C30 contains 30 questions:
28 questions regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, and body conditions from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much).
2 questions regarding state of health and Quality of life with a horizontal rating from 1 to 7; 1 (very bad), 7 (excellent).
Measured: From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
Patient reported outcomes: VAS pain assessment form
The patient´s assessment of their current level of pain on a 100-mm horizontal VAS. The left-hand extreme of the line should be described as "no pain" and the right-hand as "unbearable pain".
Measured: From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
Rate of post-operative morbidity/mortality at day 30 after surgery acc. to Clavien-Dindo classification
Rate of post-operative morbidity/mortality will be assessed at day 30 after surgery acc. to Clavien-Dindo classification.
Measured: at day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start10 Feb 2020
- Primary completion10 Oct 2021 (estimated)
- Study completion10 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zakharenko, PhD, Principal investigator, First Pavlov State Medical University of St. PetersburgIlya Vervekin, Study chair, First Pavlov State Medical University of St. Petersburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595929
- Sponsor's protocol ID
- 1-AbOn-2020
- Acronym
- GASPACCO
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.
- ClinicalTrials.gov ID
- NCT04595929
- Acronym / sponsor ID
- GASPACCO / 1-AbOn-2020
- Conditions
- Peritoneal Carcinomatosis, Gastric Cancer
- Keywords
- Gastric cancer, Aerosol Chemotherapy, Regional Chemotherapy, Peritoneal Carcinomatosis, Peritoneal washings, Intraperitoneal chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Oct 2021 (estimated)
- Study completion
- 10 Jan 2029 (estimated)
- First posted
- 22 Oct 2020 (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.
Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.
Detailed description
The study is interventional: patients over 18 years of age with an established diagnosis of stomach cancer (c)T3-4N0-3M0 CYT- will be randomized into 2 groups using the envelope method. The control group will receive only neoadjuvant chemotherapy + gastrectomy/ distal subtotal resection with D2 lymph node dissection, the active comparison group - neoadjuvant chemotherapy + gastrectomy with D2 lymph node dissection + PIPAC (Cisplatin (7.5 mg / m²) + Doxirubicin 1.5 mg / m2)). Will be assessed: overall survival, median survival, disease-free survival, quality of life of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIPAC group | Experimental | Procedure: Staging laparoscopy, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Docetaxel, Procedure: Radical surgery, Procedure: PIPAC, Drug: Adjuvant chemotherapy1. Staging laparoscopy + peritoneal lavage. 2. 4 cycles of neoadjuvant chemotherapy: FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m² every 2 weeks. 3. Radical gastrectomy with D2 - lymph node dissection. 4. Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m². 5. Adjuvant chemotherapy according to indications. |
| Control group | Active comparator | Procedure: Staging laparoscopy, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Docetaxel, Procedure: Radical surgery, Drug: Adjuvant chemotherapy1. Staging laparoscopy + peritoneal lavage. 2. 4 cycles of neoadjuvant chemotherapy: FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m² every 2 weeks. 3. Radical gastrectomy with D2 - lymph node dissection. 4. Adjuvant chemotherapy according to indications. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed, medically operable, resectable stomach adenocarcinoma (cT3-4, any N category, M0).
- No preceding cytotoxic or targeted therapy.
- No prior partial or complete tumor resection.
- Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.
- highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
Key exclusion criteria (15 listed)
- Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT.
- Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel.
- Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel.
- Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV.
- Clinically significant valvular defect.
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 |
|---|---|---|
| Staging laparoscopyAll patients undergo staging laparoscopy and peritoneal lavage. | Procedure or surgery | Control group, PIPAC group |
| 5-FluorouracilAlso: 5-FUDay 1 q2w: 2600 mg/m² IV over 24 hours | Drug | Control group, PIPAC group |
| LeucovorinAlso: CalciumfolinatDay 1 q2w: 200 mg/m² IV over 30 minutes | Drug | Control group, PIPAC group |
| OxaliplatinDay 1 q2w: 85 mg/m² IV over 2 hours | Drug | Control group, PIPAC group |
| DocetaxelDay 1 q2w: 50 mg/m² IV over 1 hour | Drug | Control group, PIPAC group |
| Radical surgeryRadical gastrectomy with D2 - lymph node dissection. | Procedure or surgery | Control group, PIPAC group |
| PIPACIntraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m². | Procedure or surgery | PIPAC group |
| Adjuvant chemotherapyAdjuvant chemotherapy according to indications. | Drug | Control group, PIPAC group |
Primary outcome
Comparison of Overall survival (OS) in both arms
Time frame: from randomization up to 5 years
Overall survival (OS) where OS is defined as the time from randomization to death from any cause.
8 secondary outcomes
Comparison of Overall survival rates at 3 and 5 years in both arms
Time frame: 3 and 5 years after randomization
Comparison of progression-/disease-free survival (PFS/DFS) between arms
Time frame: from randomization up to 5 years
Comparison of peritoneal relapse rate in both arms
Time frame: from randomization up to 5 years
PFS/DFS rates at 2, 3 & 5 years
Time frame: 2, 3 & 5 years after randomization
Rate of surgical serious adverse events (SAEs)
Time frame: After randomization of the patient until 30 days after last study-specific treatment
Patient reported outcomes: Quality of life EORTC QLQ C30 questionnaire
Time frame: From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
Patient reported outcomes: VAS pain assessment form
Time frame: From date of screening until the date of first documented progression or last visit before date of death from any cause, whichever came first, assessed 8 weeks +/- 7 days until EOT, afterwards every 3 months up to 2 years after last patient in
Rate of post-operative morbidity/mortality at day 30 after surgery acc. to Clavien-Dindo classification
Time frame: at day 30 after surgery
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 25 Nov 2020.
- Individual participant dataSharing planned: No. No IPD will be shared.
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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.
Alexander Zakharenko, PhD principal investigator
First Pavlov State Medical University of St. Petersburg
Ilya Vervekin study chair
First Pavlov State Medical University of St. Petersburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staging laparoscopy, 5-Fluorouracil and Leucovorin in people with Peritoneal Carcinomatosis and Gastric Cancer, run by St. Petersburg State Pavlov Medical University 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 15 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 25 Nov 2020. 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.
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 Alexander Zakharenko, PhD (9219516183 ext. +7, 9516183@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Overall survival (OS) in both arms (time frame: from randomization up to 5 years). 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 25 Nov 2020.