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

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ClinicalTrials.gov Identifier: NCT01226394
Recruitment Status : Unknown
Verified January 2017 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : October 22, 2010
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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 Design
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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


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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01226394


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

Locations
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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
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Study Chair: Diane GOERE, MD Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01226394    
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
HIPEC
controlled clinical trial
Additional relevant MeSH terms:
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Krukenberg Tumor
Rupture
Neoplasms
Wounds and Injuries
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Signet Ring Cell
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous