Colorectal Cancer With a Resected Minimal Synchronous PC Clinical Trial
— ProphyloCHIPOfficial title:
Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
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).
| Status | Recruiting |
| Enrollment | 130 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To increase the 3-year disease-free survival | 3-year disease-free survival | 3 years | |
| Secondary | 3 year overall survival | 3 years | ||
| Secondary | Peritoneal disease-free survival | 3 years | ||
| Secondary | 5 year overall survival | 5 years |