Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01226394
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01226394
Study Brief:
Protocol Section:
NCT01226394