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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01226394
Recruitment Status : Recruiting
First Posted : October 22, 2010
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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 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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer With a Resected Minimal Synchronous PC Ovarian Metastases Tumour Rupture in the Abdominal Cavity Procedure: laparotomy plus HIPEC Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2010
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: surveillance
Experimental: laparotomy plus HIPEC. Procedure: laparotomy plus HIPEC
Laparotomy + HIPEC

Primary Outcome Measures :
  1. To increase the 3-year disease-free survival [ Time Frame: 3 years ]
    3-year disease-free survival

Secondary Outcome Measures :
  1. 3 year overall survival [ Time Frame: 3 years ]
  2. Peritoneal disease-free survival [ Time Frame: 3 years ]
  3. 5 year overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01226394

Contact: Diane GOERE, MD

Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Diane GOERE, MD    0142114211 ext +33   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: Diane GOERE, MD Gustave Roussy, Cancer Campus, Grand Paris

Additional Information:
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT01226394     History of Changes
Other Study ID Numbers: CSET 1539-ProphyloCHIP
2009-015598-11 ( EudraCT Number )
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
peritoneal carcinomatosis
controlled clinical trial

Additional relevant MeSH terms:
Colorectal Neoplasms
Krukenberg Tumor
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Carcinoma, Signet Ring Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous