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Completed

NCT Number: NCT01226394

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

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A) Patients presenting with the following history:

  • Histologically-proven colorectal adenocarcinoma
  • 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:

  • Age between 18 and 70 years,
  • Performance Status WHO < 2, life expectancy > 12 weeks,
  • Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,
  • Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,
  • Renal function : Plasma creatinine £ 1,25 x ULN,
  • Operable patients,
  • Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
  • 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

  • Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
  • Patients presenting with a detectable recurrent tumour
  • Grade ≥ 3 Peripheral neuropathy
  • History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
  • Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant
  • Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons

Treatment and study plan

laparotomy plus HIPEC

Procedure

Laparotomy + HIPEC

Primary outcomes

  1. To increase the 3-year disease-free survival

    Time frame: 3 years

    3-year disease-free survival

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study 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

Acronym: ProphyloCHIP

Important dates

Study start
2010
Primary completion
2018
Study completion
2021
First posted
Oct 22, 2010
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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