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

This study is currently recruiting participants.
Verified January 2014 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01226394
First received: October 20, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • To increase the 3-year disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    3-year disease-free survival


Secondary Outcome Measures:
  • 3 year overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Peritoneal disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • 5 year overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: April 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: surveillance
Experimental: laparotomy plus HIPEC. Procedure: laparotomy plus HIPEC
Laparotomy + HIPEC

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226394

Contacts
Contact: Dominique Elias, MD dominique.elias@gustaveroussy.fr
Contact: Mehdi Dekkal mehdi.dekkal@gustaveroussy.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Dominique ELIAS, MD    00 33 1 42114085      
Contact: Sandrine LANCEREAU    00 33 1 42116261    sandrine.lancereau@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Dominique Elias, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01226394     History of Changes
Other Study ID Numbers: CSET 1539-ProphyloCHIP, 2009-015598-11
Study First Received: October 20, 2010
Last Updated: January 16, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on April 14, 2014