Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carc… (NCT02179489) | Clinical Trial Compass
CompletedNot Applicable
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
China271 participantsStarted 2014-11-01
Plain-language summary
Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) :
✓. Chemotherapy with FOLFOX4, mFOLFOX6, CapeOx or Capecitabine(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)
✓. Age between 18 and 75 years
✓. Performance Status (ECOG) 0, 1 or 2, life expectancy \> 12 weeks
✓. Adequate renal, and bone marrow function: a. Leukocytes \>/= 3,000/microL; b. Absolute neutrophil count \>/= 1,500/microL; c. Platelets \>/= 100,000/Ul; d. Serum creatinine \</= 1.5 mg/dL
✓. Hepatic function: a. AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of Normal) ULN
Exclusion criteria
✕. Cancers of non colorectal origin
✕. Patients presenting with a detectable recurrent tumour
✕. History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
✕. Known HIV, Hepatitis B or Hepatitis C positive
What they're measuring
1
Disease-free survival
Timeframe: Three years from the date of randomization
✕. Subjects deemed unable to comply with study and/or follow-up procedures.
✕. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity