Phase III trial evaluating the site of intraperitoneal peroperative chemo-hyperthermia (CHIP) after maximal resection of a gastric-derived peritoneal carcinomatosis associated with systemic chemotherapy

Phase 1

• Conditions: Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia (Appendix 6)I 10 Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-005748-12-ES
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-30
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

Demography
I 01 18 < age = 75 years old
Health Status
I 02. White blood cells > 3,500/mm3, neutrophils = 1,500/mm3, platelets = 100,000/mm3
I 03. Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
I 04. Performance Status =1, Karnofsky Index = 70% (Appendix 5)
I 05. Serum bilirubin = 2 mg/dl
Regulatory
I 06. Having given written informed consent prior to any procedure related to the study.
I 07. Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
I 08. Not under any administrative or legal supervision
Specific to the study
I 09. Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia (Appendix 6)
I 10 Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
AND/OR
I Females of childbearing age potential and male subjects with partners of childbearing potential using highly effective* contraceptive measures (according to CTFG recommendations). According to the clinical trial facilitation group recommendations, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to: - 4 months after the treatment with Oxaliplatin for female subjects, - 6 months after the treatment with Oxaliplatin for male subjects.

* Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

Medical history and clinical status
E 01. Prior malignant tumors with detectable signs of recurrence
E 02. Gastric stump adenocarcinoma
E 03. Presence of comorbidities, notably serious chronic diseases or organ failure (> ASA 3)
E 04. Peripheral neuropathy grade of = 3 (CTC-AE V4.0) (if appropriate)
General conditions
E 05. Any subject in exclusion period of a previous study according to applicable regulations
E.06. Pregnancy or breastfeeding
E.07. Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator
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Interfering substance
E 08. Contraindication to any drug contained in the chemotherapy régimen. Oxaliplatin is specifically contraindicated if:
?known history of hypersensitivity to oxaliplatin or to its excipients.
?myelosuppression prior to starting first course, as evidenced by baseline neutrophils <2x109/l and/or platelet count of <100x109/l.
?peripheral sensitive neuropathy with functional impairment prior to first course.
?severely impaired renal function (creatinine clearance less than 30 ml /min).

Specific to the study
E 09. Life threatening toxicity before surgery
E 10. Distant metastases (liver, lung, ovaries, etc)
E 11. Tumoral infiltration of the head or body of the pancreas
E 12. Patients presenting an adenocarcinoma of the cardia Siewert I or II
E 13. Existence of macroscopic peritoneal implants
E 14. Patients with clinically significant ascites (> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified