Gastric CancerPhase 2NCT05541146
Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis
A Phase 2 study testing Intraperitoneal chemotherapy in people with Gastric Cancer and Peritoneal Carcinomatosis, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Peritoneal carcinomatosis (PC) in gastric cancer (GC) is considered a fatal disease, without expectation of definitive cure. Since conventional surgery is not indicated in the palliative setting, and systemic chemotherapy treatments are not sufficient to contain the disease, a multimodal approach associating… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Peritoneal Carcinomatosis
- What is being tested?
- Intraperitoneal chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2022to Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Gastric adenocarcinoma
- Presence of peritoneal carcinomatosis documented through intraoperative identification and confirmed by biopsies and/or positive oncotic cytology;
- Presence of exclusively peritoneal metastasis with PCI < 12;
- Age between 18 and 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1;
- Body mass index (BMI) greater than 18;
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- Total WBC count ≥3000, neutrophils ≥1500, hemoglobin ≥8, and platelet count ≥100,000;
- Bilirubin <2, TGO/TGP/FA/GGT 3x the reference value;
- Creatinine clearance calculated by the Cockcroft-Gault formula ≥ 50 ml/min.
Who cannot join
- Synchronous or metachronic neoplasms;
- Previous antineoplastic treatment for gastric cancer;
- Clinical conditions considered critical by the investigator;
- Obstruction of the digestive tract;
- Suspected gastrointestinal bleeding;
- New York Heart Association functional class II/III/IV heart failure;
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- Heart disease that, in the opinion of the investigator, prevents the patient from receiving the necessary hydration during chemotherapy with cisplatin.
- Known HIV infection or chronic use of immunosuppressants;
- Acute myocardial infarction or stroke in the last 6 months
- pregnant.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer de São Paulo - ICESP
São Paulo, São Paulo
Andre Roncon Dias, MD, PhD, andre.dias@hc.fm.usp.br
Andre Roncon Dias, MD, PhD
About this study
Official title: Evaluation of Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer in Patients With Peritoneal Carcinomatosis
Peritoneal carcinomatosis (PC) in gastric cancer (GC) is considered a fatal disease, without expectation of definitive cure. Since conventional surgery is not indicated in the palliative setting, and systemic chemotherapy treatments are not sufficient to contain the disease, a multimodal approach associating intraperitoneal (IP) chemotherapy (CMT) with surgery may represent an alternative for these patients.
IP CMT has shown superior results to conventional treatment in patients at this stage of the disease, and can achieve complete regression of lesions in a significant portion of cases. Once response to treatment is achieved, patients become fit for curative surgery, which offers a new perspective on the survival in these previously unresectable cases, and raising survival rates to similar levels to patients undergoing surgery with curative intention.
Read more
Thus, the aim of this study is to evaluate the complete response rate and curative resection in patients with PC by GC at Instituto do Cancer do Estado de São Paulo (ICESP) treated with IP CMT. Patients prospectively included in the study will undergo implantation of a peritoneum catheter to perform outpatient IP CMT in order to promote the regression of lesions. Those with complete regression may be referred for surgical treatment, curing a portion of these patients. The diagnosis of PC will be performed by conventional cytological, immunohistochemical and liquid cytology methods to determine the presence of tumor cells in the peritoneal lavage and to evaluate the sensitivity of the methods. In addition, it is proposed in the study the storage of material for further study of circulating markers in peripheral blood and peritoneal lavage that may be related to response or resistance to treatment.
It is believed that IP CMT may not only increase the survival of patients with PC, but also offer the possibility of cure for a significant portion of patients who are currently without treatment prospects and with a median survival of only six months.
Read the detailed description
This is a prospective study lasting 36 months.
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Being tested
- Intraperitoneal chemotherapy
- Keywords
- Gastric Cancer, intraperitoneal chemotherapy, gastric adenocarcinoma, conversion surgery, stage IV gastric cancer, peritoneal metastases, carcinomatosis
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal chemotherapyCombination product
Also called Implantation of intraperitoneal catheter for chemotherapy with Paclitaxel
Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal chemotherapy | Experimental | Intraperitoneal chemotherapy in gastric cancer patients with peritoneal carcinomatosis. Receives: Combination Product: Intraperitoneal chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete peritoneal response after 04 cycles of intraperitoneal (IP) chemotherapy (CMT) associated with systemic CMT with XP.
Absence of visible carcinomatosis on imaging tests, absence of viable peritoneal lesion at laparoscopy and absence of neoplastic cells in peritoneal lavage.
Measured: At the end of Cycle 4 (each cycle is 8 days)
Secondary outcomes (2)
Progression-free survival (PFS)
Time between conversion surgery and date of disease progression, assessed in the first 6 months
Measured: 6 months
Overall survival (OS)
Time between conversion surgery and last follow-up after 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jun 2022
- Primary completionJul 2024 (estimated)
- Study completionJan 2025 (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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Roncon Dias, MD, PhD, Principal investigator, Instituto do Câncer de São Paulo - ICESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541146
- Sponsor's protocol ID
- NP 1507/19
- Other IDs
- 26306419.8.0000.0065, 2020/13249-0
- Status last verified
- Sep 2022
- First submitted
- 23 Aug 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer in Patients With Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT05541146
- Acronym / sponsor ID
- NP 1507/19
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Keywords
- Gastric Cancer, intraperitoneal chemotherapy, gastric adenocarcinoma, conversion surgery, stage IV gastric cancer, peritoneal metastases, carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Sep 2022 (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.
Peritoneal carcinomatosis (PC) in gastric cancer (GC) is considered a fatal disease, without expectation of definitive cure. Since conventional surgery is not indicated in the palliative setting, and systemic chemotherapy treatments are not sufficient to contain the disease, a multimodal approach associating intraperitoneal (IP) chemotherapy (CMT) with surgery may represent an alternative for these patients.
IP CMT has shown superior results to conventional treatment in patients at this stage of the disease, and can achieve complete regression of lesions in a significant portion of cases. Once response to treatment is achieved, patients become fit for curative surgery, which offers a new perspective on the survival in these previously unresectable cases, and raising survival rates to similar levels to patients undergoing surgery with curative intention.
Thus, the aim of this study is to evaluate the complete response rate and curative resection in patients with PC by GC at Instituto do Cancer do Estado de São Paulo (ICESP) treated with IP CMT. Patients prospectively included in the study will undergo implantation of a peritoneum catheter to perform outpatient IP CMT in order to promote the regression of lesions. Those with complete regression may be referred for surgical treatment, curing a portion of these patients. The diagnosis of PC will be performed by conventional cytological, immunohistochemical and liquid cytology methods to determine the presence of tumor cells in the peritoneal lavage and to evaluate the sensitivity of the methods. In addition, it is proposed in the study the storage of material for further study of circulating markers in peripheral blood and peritoneal lavage that may be related to response or resistance to treatment.
It is believed that IP CMT may not only increase the survival of patients with PC, but also offer the possibility of cure for a significant portion of patients who are currently without treatment prospects and with a median survival of only six months.
Detailed description
This is a prospective study lasting 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy.
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal chemotherapy | Experimental | Combination Product: Intraperitoneal chemotherapyIntraperitoneal chemotherapy in gastric cancer patients with peritoneal carcinomatosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gastric adenocarcinoma
- Presence of peritoneal carcinomatosis documented through intraoperative identification and confirmed by biopsies and/or positive oncotic cytology;
- Presence of exclusively peritoneal metastasis with PCI < 12;
- Age between 18 and 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance scale 0 and 1;
Key exclusion criteria (10 listed)
- Synchronous or metachronic neoplasms;
- Previous antineoplastic treatment for gastric cancer;
- Clinical conditions considered critical by the investigator;
- Obstruction of the digestive tract;
- Suspected gastrointestinal bleeding;
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 |
|---|---|---|
| Intraperitoneal chemotherapyAlso: Implantation of intraperitoneal catheter for chemotherapy with PaclitaxelPatients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy | Combination product | Intraperitoneal chemotherapy |
Primary outcome
Rate of complete peritoneal response after 04 cycles of intraperitoneal (IP) chemotherapy (CMT) associated with systemic CMT with XP.
Time frame: At the end of Cycle 4 (each cycle is 8 days)
Absence of visible carcinomatosis on imaging tests, absence of viable peritoneal lesion at laparoscopy and absence of neoplastic cells in peritoneal lavage.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 6 months
Overall survival (OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- 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. This study is not recruiting at the moment.
Andre Roncon Dias, MD, PhD principal investigator
Instituto do Câncer de São Paulo - ICESP
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 Intraperitoneal chemotherapy in people with Gastric Cancer and Peritoneal Carcinomatosis, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andre Roncon Dias, MD, PhD (+55 11 3893-2000, andre.dias@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete peritoneal response after 04 cycles of intraperitoneal (IP) chemotherapy (CMT) associated with systemic CMT with XP. (time frame: At the end of Cycle 4 (each cycle is 8 days)). 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 23 Mar 2023.