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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer With a Resected Minimal Synchronous PC, or Ovarian Metastases,, or Tumour Rupture in the Abdominal Cavity

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To increase the 3-year disease-free survival

Outcome Description:

3-year disease-free survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CSET 1539-ProphyloCHIP

NCT ID:

NCT01226394

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Colorectal Cancer With a Resected Minimal Synchronous PC
  • or Ovarian Metastases,
  • or Tumour Rupture in the Abdominal Cavity
  • peritoneal carcinomatosis
  • HIPEC
  • controlled clinical trial
  • Colorectal Neoplasms
  • Fever
  • Krukenberg Tumor
  • Neoplasm Metastasis
  • Carcinoma
  • Rupture

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