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NCT Number: NCT01524094

Cytoreduction and Intraperitoneal Chemotherapy Versus 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.

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Key information

Conditions

Colorectal Peritoneal Carcinomatosis Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Akademiska Sjukhuset (Uppsala University Hospital)

Uppsala, SE-751 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

Drug

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.

Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)

Procedure

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.

Primary outcomes

  1. Overall survival

    Time frame: 8 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.

Important dates

Study start
2003
Primary completion
2010
Study completion
2012
First posted
Feb 1, 2012
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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