Gastric Cancer (GC), HIPEC, Hyperthermic Intraperitoneal Chemoperfusion, Peritoneal Metastases From Gastric Cancer
Conditions
Keywords
Gastric cancer, HIPEC, Hyperthermic Intraperitoneal Chemoperfusion, FLOT, Lymphadenectomy, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases, Stomach Diseases, Stomach Neoplasms, Chemotherapy, Adjuvant, Combined Modality Therapy, Drug Therapy, Surgical Procedures
Brief summary
The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.
Detailed description
Several recent studies showed that near-perfect curative-intent R0 surgical technique combined with systemic chemotherapy or even immunotherapy may not always be enough to eliminate microscopic deposits or eliminate peritoneal dissemination in locally advanced gastric cancer or low peritoneal cancer-index (PCI) tumors. The risk of peritoneal dissemination is especially high for T4 tumors, for those with cytologically positive peritoneal washings. Moreover, the risk of peritoneal relapse in low PCI tumors is remarkably high. Combination of surgery and intraperitoneal chemotherapy aims to minimise the risks of the aforementioned peritoneal progression. In the study investigators perform curative surgery followed by single dose of hyperthermic intraperitoneal chemotherapy (HIPEC).
Interventions
PROCEDUREcurative-intent surgery + HIPEC
Participants enrolled in this study will undergo curative-intent gastrectomy for gastric cancer, immediately followed by Hyperthermic Intraperitoneal Chemotherapy (HIPEC) performed during the same operative session. Dosage of drugs: mitomycin C 15 mg/m2, cisplatin 75mg/m2. The procedure is conducted according to a standardized protocol in National Cancer Institute
Sponsors
Ukrainian Society of Clinical Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 2. Hystologicaly proven gastric adenocarcinoma 3. ECOG status 0-1 4. Written consent to participate in the study 5. Medically and technically operable gastric tumor 6. Only T4a or T4b tumours with any peritoneal cytology status 7. Cytologically positive peritoneal washings (cyt+) with any T and N criteria 8. Adequate haemopoetic, renal and hepatic function (Hb \> 120, PLT \> 150\*10\^9/l, ALT \< 60, AST \<40, total bilirubin \< 21 µmol/l, Creatinine clearance (male - 90-140, female - 80-130 ml/min)
Exclusion criteria
1. Pregnancy/breastfeeding 2. ECOG status 2-4 3. Concomitant malignancy 4. Mitomycin and/or Cisplatin hypersensitivity 5. Uncontrollable chronic diseases 6. Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years. 7. Presence of metastases other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes) 8. History of allergic reactions associated with cisplatin and Mitomycin C 9. Patients with psychiatric illness/social situations with impaired compliance 10. •Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal recurrence rate | From enrolment up to 5 years of follow-up | Number of patients developed peritoneal recurence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraperitoneal chemotherapy complications rate | 30 days after chemotherapy | Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5) |
| Postoperative complications rate | 30 days after surgery | Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5) |
| 5-years overall survival | From the time of diagnosis up to 5 years of follow-up | 5-years overall survival |
| Distant recurrence rate | Time from diagnosis up to 5 years of follow-up | Time from diagnosis to distant reccurence |
| Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0 | 6 months after treatment completion | Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0 (lower score means better outcomes, higher score means worse outcomes) |
| Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach | 6 months after treatment completion | Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (lower score means better outcomes, higher score means worse outcomes) |
| 5-years relapse-free survival rate | Time from diagnosis up to 5 years of follow-up | 5-years relapse-free survival rate |
Countries
Ukraine
Contacts
Primary ContactOleksiy Dobrzhanskyi, MD
Outcome results
None listed