We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01524094
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):

January 18, 2012
February 1, 2012
February 1, 2012
June 2003
December 2010   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: 8 years ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis
A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.
The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Peritoneal Carcinomatosis
  • 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.
  • 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.
  • Experimental: Arm A: CRS plus postop intraperitoneal chemotherapy.
    Cytoreductive surgery and postoperative intraperitoneal chemotherapy.
    Intervention: Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
  • Active Comparator: Arm B: Systemic chemotherapy alone
    Systemic chemotherapy alone
    Intervention: Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
January 2012
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease)
  • verified primary tumor of adenocarcinoma of the colon or rectum
  • Potential resectability as judged by the treating surgeon
  • Patient is available for follow-up according to the study protocol
  • Signed informed consent

Exclusion Criteria:

  • Extraabdominal metastases or liver metastases
  • Paraaortic or other inoperable lymph node metastases
  • Clear indication for surgery only (such as obstruction, bleeding or peritonitis)
  • Prior treatment of either arm in the study
  • Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma
  • Age > 80
  • Contraindications for chemotherapy
  • Pregnancy or breastfeeding
  • Ongoing infection
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01524094
SPS-1
No
Not Provided
Not Provided
Wilhelm Graf, M.D., Ph.D., Uppsala University
Uppsala University
Not Provided
Principal Investigator: Wilhelm Graf, M.D. Ph.D Uppsala University
Uppsala University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP