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. Identifier: NCT01524094
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 1, 2012
Information provided by (Responsible Party):
Wilhelm Graf, M.D., Ph.D., Uppsala University

Brief Summary:
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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 8 years ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 8 years ]
  2. Time to secondary treatment [ Time Frame: 8 years ]
  3. Radical resectability [ Time Frame: 5 years ]
  4. Quality of life [ Time Frame: 7 years ]
  5. Health costs [ Time Frame: 8 years ]
  6. Side effects of treatment [ Time Frame: 6 years ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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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 identifier (NCT number): NCT01524094

Akademiska Sjukhuset (Uppsala University Hospital)
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Uppsala University
Principal Investigator: Wilhelm Graf, M.D. Ph.D Uppsala University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wilhelm Graf, M.D., Ph.D., M.D., PhD., Uppsala University Identifier: NCT01524094     History of Changes
Other Study ID Numbers: SPS-1
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Wilhelm Graf, M.D., Ph.D., Uppsala University:
colorectal cancer
cytoreductive surgery
intraperitoneal chemotherapy
systemic chemotherapy
Peritoneal Metastatic Disease From the Colon or Rectum

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances