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

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

Tracking Information

• First Submitted Date: October 20, 2010
• First Posted Date: October 22, 2010
• Last Update Posted Date: January 26, 2017
• Study Start Date: April 2010
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2010)

To increase the 3-year disease-free survival [ Time Frame: 3 years ]

3-year disease-free survival

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 3, 2012)

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

Original Secondary Outcome Measures (submitted: October 21, 2010)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Colorectal Cancer With a Resected Minimal Synchronous PC
• Ovarian Metastases
• Tumour Rupture in the Abdominal Cavity

Intervention

Procedure: laparotomy plus HIPEC

Laparotomy + HIPEC

Study Arms

• No Intervention: surveillance
• Experimental: laparotomy plus HIPEC.
  Intervention: Procedure: laparotomy plus HIPEC

• Publications *: Goere D, Glehen O, Quenet F, Guilloit JM, Bereder JM, Lorimier G, Thibaudeau E, Ghouti L, Pinto A, Tuech JJ, Kianmanesh R, Carretier M, Marchal F, Arvieux C, Brigand C, Meeus P, Rat P, Durand-Fontanier S, Mariani P, Lakkis Z, Loi V, Pirro N, Sabbagh C, Texier M, Elias D; BIG-RENAPE group. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol. 2020 Sep;21(9):1147-1154. doi: 10.1016/S1470-2045(20)30322-3. Epub 2020 Jul 24.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 21, 2010): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2019
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01226394
• Other Study ID Numbers: CSET 1539-ProphyloCHIP; 2009-015598-11 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• Original Responsible Party: Docteur Domnique ELIAS, Institut Gustave Roussy
• Current Study Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Diane GOERE, MD; Gustave Roussy, Cancer Campus, Grand Paris

• PRS Account: Gustave Roussy, Cancer Campus, Grand Paris
• Verification Date: January 2017