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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00769405
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal cancer
* Peritoneal carcinoma extension ≤ 25 (Sugarbaker Index) (determined intraoperatively)
* Planning to receive standard systemic chemotherapy
* Chemotherapy for metastatic cancer should be initiated 3 months after surgery
* No extraperitoneal metastases, including liver and lung metastasis
* No carcinomatosis of other origin besides colorectal, in particular appendical carcinomatosis
* Macroscopically complete resection (R1) or surgical reduction of tumor to a residual thickness ≤ 1 mm (R2) is possible
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Life expectancy \> 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Creatinine ≤ 1.25 times ULN
* Eligible for surgery
* No peripheral neuropathy \> grade 3
* Not pregnant or nursing
* No other cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No inability to submit to follow-up medical testing for geographical, social, or psychological reasons
* Affiliated with a social security program
* Not deprived of liberty or under supervision
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemohyperthermia
* No concurrent participation in another study of first-line therapy for this cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00769405
Study Brief:
Protocol Section:
NCT00769405