Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis
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|ClinicalTrials.gov Identifier: NCT01524094|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Peritoneal Carcinomatosis||Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2012|
Experimental: Arm A: CRS plus postop intraperitoneal chemotherapy.
Cytoreductive surgery and postoperative intraperitoneal chemotherapy.
Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.
Active Comparator: Arm B: Systemic chemotherapy alone
Systemic chemotherapy alone
Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)
Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.
- Overall survival [ Time Frame: 8 years ]
- progression free survival [ Time Frame: 8 years ]
- Time to secondary treatment [ Time Frame: 8 years ]
- Radical resectability [ Time Frame: 5 years ]
- Quality of life [ Time Frame: 7 years ]
- Health costs [ Time Frame: 8 years ]
- Side effects of treatment [ Time Frame: 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524094
|Akademiska Sjukhuset (Uppsala University Hospital)|
|Uppsala, Sweden, SE-751 85|
|Principal Investigator:||Wilhelm Graf, M.D. Ph.D||Uppsala University|