Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

Uppsala University

Status and phase: Completed; Phase 3

Conditions: Colorectal Peritoneal Carcinomatosis

Treatments: Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin); Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01524094

SPS-1

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Arm A: CRS plus postop intraperitoneal chemotherapy.

Experimental group

Description:

Cytoreductive surgery and postoperative intraperitoneal chemotherapy.

Treatment:

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

Arm B: Systemic chemotherapy alone

Active Comparator group

Description:

Systemic chemotherapy alone

Treatment:

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