Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

• Register: EUCTR
• Last refreshed on: 13 May 2013
• Main ID: EUCTR2006-006175-20-ES
• Date of registration: 17/12/2012
• Prospective Registration: Yes
• Primary sponsor: UNICANCER
• Public title: Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
• Scientific title: Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer - PICH
• Date of first enrolment: 08/04/2013
• Target sample size: 264
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006175-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: maximal surgery without chemohyperthermia Number of treatment arms in the trial: 2

Countries of recruitment

France, Spain

Contacts

• Name: BEATA JUZYNA
• Affiliation: Unicancer

• Name: BEATA JUZYNA
• Affiliation: Unicancer

Key inclusion & exclusion criteria

Inclusion criteria:
1) Histologically confirmed colorectal cancer,
2) Minimal or moderate peritoneal carcinosis with a Sugarbaker peritoneal score ? à 25 (see
annex 9), (peroperatory assessment),
3) A surgically obtained tumor reduction, macroscopically complete R1 or with a residual
thickness not exceeding 1 mm (R2), (peroperatory assessment)
4) Absence of extra peritoneal metastases including hepatic and pulmonary metastases (
confirmed by a PET scan, if possible),
5) Patient to be treated by systemic chemotherapy for its carcinosis,
6) 18 ? age ? 70 yo,
7) WHO performance status ? 1,
8) Life expectancy > 12 weeks,
9) Adequate hematological function: polynuclear neutrophiles ? 1,5x10
9
/L, platelets ? 100x10
9
/L,
10) Adequate hepatic function : total bilirubin ? 1,5 x ULN, ASAT (SGOT) and ALAT (SGPT) ? 3 x
ULN, alkaline phosphatases ? 3 x ULN,
11) Seric creatinine ? 1,25 x ULN,
12) Operable patient,
13) Peripheral neuropathy with grade ? 3 (CTC AE v3.0 annex 7)
14) Patient information and written informed consent form signed before any protocol specific
procedure is started.
15) Patient is affiliated with a proper/French national health insurance fund
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion criteria:
1) Carcinosis of other-than-colorectal origin, specifically appendiculary carcinomas,
2) Large volume carcinosis with Sugarbaker peritoneal-extent score >25 (annex 9), (peroperatory
assessment)
3) Patient has already been treated by chemohyperthermia
4) History of previous cancer (except cutaneous basocellular carcinoma or in situ carcinoma of
the uterine cervix) with a relapse occurred within the 5-year period prior to inclusion,
5) Patient already included in another first-line therapeutic trial aimed at the same disease study,
6) Pregnant women, women who are likely to become pregnant or are breast-feeding,
7) Individual deprived of liberty or placed under the authority of a tutor,
8) Patients with any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
MedDRA version: 14.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: ELOXATINE®
Product Name: ELOXATINE®
Product Code: NON APPLICABLE
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Oxaliplatine
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: FOLINATO CÁLCICO
Product Name: Calcium Lévofolinate
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Acide folinique
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: FLUOROURACILO
Product Name: Fluorouracile
Product Code: NA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracile
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: To compare the overall survival in patients affected with peritoneal carcinosis of
colorectal origin and having undergone a macroscopically complete or suboptimal (with unresected residual tumor tissues ? 1mm) surgical resection and benefiting from a maximized treatment with chemotherapy (i.e.: maximal surgery + chemohyperthermia + pre- or post-operatory systemic chemotherapy) or a maximized treatment without chemohyperthermia (i.e.: maximal surgery + pre-or post-operatory systemic chemotherapy).

Secondary Objective: ?Evaluate recurrence-free survival of these patients.
?Evaluate treatment toxicities.
?Determine morbidity from surgical complications.
?Determine prognostic factors of survival.

Primary end point(s): Overall survival will be taken into account. Estimate of the median survival is 30 months in the
control group. The trial objective is to increase the median survival time to 48 months using the
experimental treatment PICH (hazard ratio = 0.625).

Timepoint(s) of evaluation of this end point: 7 years

Secondary Outcome(s)

Secondary end point(s): Survival without relapse : the following cases will be considered as relapse :
- Histologically confirmed relapse or a suggestive context (palpable nodules, visible on
imaging, with concomitant elevation of significant markers)
- Distant relapse (evident on imaging or Histologically confirmed),
- Any patient's death.

Treatment toxicity : according to the CTC AE v3.0 scale (annex 7)
Surgical complications :
- Abdominal complications : (digestive fistula, urinary fistula, deep abscess without fistula,
hemoperitoneum, number of percutaneous drainages)
- Extra-abdominal complications: (pulmonary, infectious urinary, central catheter infection,
venous (thrombo-embolic), parietal, renal insufficiency, cardiac disorders)
- Aplasia: postoperatory, febrile aplasia or other non-febrile complications.

Morbidity :
- Patients' deaths occurring within 60 days following surgery,
- Serious hemorrhages (> 30 % of blood volume),
- Serious hemodynamic impairments,
- Any visceral impairments, notably :
o Renal insufficiency or rhabdomyolysis requiring dialysis.
o Respiratory impairment requiring assisted ventilation = 2 days.
o Hepatic impairment: bilirubine > 10 N.
o Serious neurophysiological and motricity disorders.
- Parenteral feeding at home > 1 month,
- Any infectious complication (locoregional infection, abscess drainage?.)
- Grade 4 thrombopenia (< 25 000), Neutropenia < 500 PN, blood transfusion > 4 CG,
Diarrheas > 15 times/day and beyond D21, serious decrease of auditive capacity,
- Any SAE putting the vital prognosis at stake or causing permanent invalidity or
serious temporary incapacity.
-Survival prognostic factors

Timepoint(s) of evaluation of this end point: 7 years

Secondary ID(s)

2006-006175-20-FR

UC-0110/0608

Source(s) of Monetary Support

UNICANCER