Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients (ProphyloCHIP)

Gustave Roussy

Status and phase: Unknown; Phase 3

Conditions: Ovarian Metastases; Tumour Rupture in the Abdominal Cavity; Colorectal Cancer With a Resected Minimal Synchronous PC

Treatments: Procedure: laparotomy plus HIPEC

Study type: Interventional

Funder types: Other

Identifiers

NCT01226394

2009-015598-11 (EudraCT Number)

CSET 1539-ProphyloCHIP

Details and patient eligibility

About

Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A) Patients presenting with the following history:

1. Histologically-proven colorectal adenocarcinoma

2. Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) :

   • Minimal PC, resected at the same time as the primary
   • Ovarian metastases
   • Rupture of the primary tumour inside the peritoneal cavity,
   • Iatrogenic rupture of the primary tumour during surgery

B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :

• Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified...).
• Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons...);

C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy.

D) Patients with the following general characteristics:

1. Age between 18 and 70 years,
2. Performance Status WHO < 2, life expectancy > 12 weeks,
3. Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,
4. Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,
5. Renal function : Plasma creatinine £ 1,25 x ULN,
6. Operable patients,
7. Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
8. Patients entitled to French National Health Insurance coverage.

E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.

Exclusion criteria

1. Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
2. Patients presenting with a detectable recurrent tumour
3. Grade ≥ 3 Peripheral neuropathy
4. History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
5. Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant

7. Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

surveillance

No Intervention group

laparotomy plus HIPEC.

Experimental group

Treatment:

Procedure: laparotomy plus HIPEC