Status:
UNKNOWN
Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Colorectal Cancer With a Resected Minimal Synchronous PC
Ovarian Metastases
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 pr...
Eligibility Criteria
Inclusion
- A) Patients presenting with the following history:
- Histologically-proven colorectal adenocarcinoma
- 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:
- Age between 18 and 70 years,
- Performance Status WHO \< 2, life expectancy \> 12 weeks,
- Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,
- Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,
- Renal function : Plasma creatinine £ 1,25 x ULN,
- Operable patients,
- Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
- 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
- Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
- Patients presenting with a detectable recurrent tumour
- Grade ≥ 3 Peripheral neuropathy
- History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01226394
Start Date
April 1 2010
End Date
June 1 2019
Last Update
January 26 2017
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800