Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer
A Randomized, Multicenter, Controlled Study to Compare Hyperthermic Intraperitoneal Chemotherapy Plus Paclitaxel IP/IV, S-1 and Paclitaxel IP/IV，S-1 as Conversion Therapy for Gastric Cancer Patients With Peritoneal Metastasis
1 other identifier
interventional
180
1 country
1
Brief Summary
The main purpose of this study is to compare Hyperthermic Intraperitoneal Chemotherapy combined with Chemotherapy and Chemotherapy as a conversion therapy for gastric Cancer Patients with peritoneal metastasis in Safety and Effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Sep 2020
Typical duration for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedFebruary 8, 2022
September 1, 2021
3 years
November 30, 2020
January 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
R0 resection rate
1 year
Secondary Outcomes (1)
1 year overall survival
1 year
Study Arms (2)
HIPEC plus Paclitaxel IP/IV, S-1
EXPERIMENTALAfter laparoscopic exploration, HIPEC was started immediately, at least 4 HIPEC was completed.Three to six weeks after HIPEC was completed, chemotherapy was started.The curative effect was evaluated every 2-4 cycles. If the operation standard of R0 was met, the second laparoscopic staging was performed: if the peritoneal metastasis reached P 0 or P1a, the operator judged that R0 could be removed. Open radical gastrectomy (D2 / D2 +) was performed. For P1b / c cases, the original treatment was continued until the disease progressed.
Paclitaxel IP/IV, S-1
NO INTERVENTIONWithin one week after laparoscopic exploration, chemotherapy was started. The curative effect was evaluated every 2-4 cycles. If the operation standard of R0 was met, the second laparoscopic staging was performed: if the peritoneal metastasis reached P 0 or P1a, the operator judged that R0 could be removed. Open radical gastrectomy (D2 / D2 +) was performed. For P1b / c cases, the original treatment was continued until the disease progressed.
Interventions
After laparoscopic exploration, HIPEC was started immediately: the temperature was 43 ℃ and the duration was 60 min. paclitaxel (PTX) was used with a dose of 50mg / m2. The second HIPEC was completed 24-48 hrs after the first HIPEC, and at least 4 HIPEC was completed.
A natural anticancer drug that has been widely used in the treatment of breast, ovarian and some head and neck and lung cancers.Three to six weeks after HIPEC was completed, chemotherapy was started:: PTX: 50mg / m2 IV, D1, D8; PTX: 20mg / m2 IP, D1, D8; q3w; S-1: 60mg / m2, bid, d1-14, repeated every 3 weeks.
S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum).Three to six weeks after HIPEC was completed, chemotherapy was started:: PTX: 50mg / m2 IV, D1, D8; PTX: 20mg / m2 IP, D1, D8; q3w; S-1: 60mg / m2, bid, d1-14, repeated every 3 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosed as gastric adenocarcinoma by pathology and had not received any other anti-tumor treatment such as radiotherapy and chemotherapy;
- ≥ 18 and ≤ 70 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1;
- Intraoperative pathological diagnosis was peritoneal metastasis (stage ≤ P1b), with or without ascites (ascites volume exceeding pelvic cavity but not reaching full abdominal ascites)
- Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin time) was within normal range; creatine ≤ 1.5 x ULN;
- Written informed consent provided;
You may not qualify if:
- Diagnosed as Her-2(+++)/FISH(+) by pathology;
- With other distant metastasis(ovarian metastasis was excluded)
- Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency;
- Organ transplantation patients need immunosuppressive therapy;
- Severe recurrent infections were not controlled or with other serious concomitant diseases;
- Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment;
- Within 6 months before study starts and in the process of this study, patients participate in other clinical researches;
- Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders;
- Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
- Patients without legal capacity,or medical/ethical reasons may influence the study to continue.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
February 8, 2022
Study Start
September 1, 2020
Primary Completion
August 31, 2023
Study Completion
October 31, 2023
Last Updated
February 8, 2022
Record last verified: 2021-09