GASTRICHIP TRIAL. D2 resection and HIPEC (Hyperthermic IntraPeritoneal Chemoperfusion) in locally advanced gastric carcinoma.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

24 Jun 2013 → ongoing

Decision date (initial)

2024-08-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

French Ministry of Health

External identifiers

EU CT number

2024-516358-23-00

EudraCT number

2012-005748-12

ClinicalTrials.gov

NCT01882933

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive cytology), treated either with curative gastrectomy and adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Arm A), or with curative gastrectomy alone (Arm B).

Secondary objectives 6

1. Compare 3-year and 5-year recurrence-free survival;
2. Study the incidence of locoregional recurrence and compare locoregional recurrence-free 5-year survival;
3. Assess and compare treatment-related toxicity (Common Terminology Criteria for Adverse Events v4.0);
4. Compare sites of recurrence;
5. Identify prognostic factors of overall 5-year survival and recurrencefree 5-year survival;
6. Compare patients' quality of life at preoperative time, M3, M6 and M12 and changes of quality of life.

Conditions and MedDRA coding

Gastric adenocarcinoma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 18 < age ≤ 75 years old
2. White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
3. Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
4. Performance Status ≤1, Karnofsky Index ≥ 70%
5. Serum bilirubin ≤ 2 mg/dl
6. Having given written informed consent prior to any procedure related to the study
7. Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
8. Not under any administrative or legal supervision Specific to the study
9. Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia
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).
11. Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).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.

Exclusion criteria 14

1. Prior malignant tumors with detectable signs of recurrence
2. Tumoral infiltration of the head or body of the pancreas
3. Patients presenting an adenocarcinoma of the cardia Siewert I or II
4. Existence of macroscopic peritoneal implants
5. 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
6. Gastric stump adenocarcinoma
7. Presence of comorbidities, notably serious chronic diseases or organ failure (ASA > 3)
8. Peripheral neuropathy grade of ≥ 3 (CTC-AE V4.0) (if appropriate)
9. Any subject in exclusion period of a previous study according to applicable regulations
10. Pregnancy or breastfeeding
11. Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator
12. Contraindication to any drug contained in the chemotherapy regimen - Life threatening toxicity before surgery
13. Distant metastases (liver, lung. ovaries, etc)
14. Life threatening toxicity before surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival

Secondary endpoints 5

1. Recurrence-free survivals (peritoneal recurrence, locoregional recurrence, metastatic recurrence, site of recurrence )
2. Treatment-related toxicity
3. Treatment-related mortality
4. Treatment related morbidity
5. Quality of life

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Olivier GLEHEN

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Olivier GLEHEN

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications