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

NCT ID: NCT01226394

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2019-06-30

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surveillance

Group Type: NO_INTERVENTION

No interventions assigned to this group

laparotomy plus HIPEC.

Group Type: EXPERIMENTAL

laparotomy plus HIPEC

Intervention Type: PROCEDURE

Laparotomy + HIPEC

Interventions

laparotomy plus HIPEC

Laparotomy + HIPEC

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diane GOERE, MD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Gustave Roussy

Villejuif, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Diane GOERE, MD

Role: CONTACT

diane.goere@gustaveroussy.fr

Facility Contacts

Diane GOERE, MD

Role: primary

diane.goere@gustaveroussy.fr

0142114211 ext. +33

References

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.

Reference Type: DERIVED

PMID: 32717180 (View on PubMed)

Related Links

http://igr.fr

Related Info

Other Identifiers

2009-015598-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSET 1539-ProphyloCHIP

Identifier Type: -

Identifier Source: org_study_id