Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilhelm Graf, M.D., Ph.D., Uppsala University
ClinicalTrials.gov Identifier:
NCT01524094
First received: January 18, 2012
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Time to secondary treatment [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Radical resectability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Health costs [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Side effects of treatment [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: June 2003
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524094

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

Publications:
Responsible Party: Wilhelm Graf, M.D., Ph.D., M.D., PhD., Uppsala University
ClinicalTrials.gov Identifier: NCT01524094     History of Changes
Other Study ID Numbers: SPS-1
Study First Received: January 18, 2012
Last Updated: January 31, 2012
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Uppsala University:
colorectal cancer
cytoreductive surgery
intraperitoneal chemotherapy
systemic chemotherapy
Peritoneal Metastatic Disease From the Colon or Rectum

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 15, 2014