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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Colorectal Peritoneal Carcinomatosis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

8 years

Safety Issue:

No

Principal Investigator

Wilhelm Graf, M.D. Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Uppsala University

Authority:

Sweden: Swedish National Council on Medical Ethics

Study ID:

SPS-1

NCT ID:

NCT01524094

Start Date:

June 2003

Completion Date:

January 2012

Related Keywords:

  • Colorectal Peritoneal Carcinomatosis
  • colorectal cancer
  • cytoreductive surgery
  • intraperitoneal chemotherapy
  • systemic chemotherapy
  • Peritoneal Metastatic Disease From the Colon or Rectum
  • Carcinoma

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