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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. (see Contacts and Locations)
Verified January 2017 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 25, 2017
Last verified: January 2017
  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
Ovarian Metastases
Tumour Rupture in the Abdominal Cavity
Procedure: laparotomy plus HIPEC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    3-year disease-free survival


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

Estimated Enrollment: 130
Study Start Date: April 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Diane GOERE, MD diane.goere@gustaveroussy.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Diane GOERE, MD    0142114211 ext +33    diane.goere@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Diane GOERE, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
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 ( EudraCT Number )
Study First Received: October 20, 2010
Last Updated: January 25, 2017

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

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

ClinicalTrials.gov processed this record on March 29, 2017