Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

Colorectal Peritoneal Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524094
• Other study ID #: SPS-1
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2012
• Last updated: January 31, 2012
• Start date: June 2003
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Peritoneal Carcinomatosis

Intervention

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.

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.

Locations

Country	Name	City	State
Sweden	Akademiska Sjukhuset (Uppsala University Hospital)	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Assersohn L, Norman A, Cunningham D, Benepal T, Ross PJ, Oates J. Influence of metastatic site as an additional predictor for response and outcome in advanced colorectal carcinoma. Br J Cancer. 1999 Apr;79(11-12):1800-5. — View Citation

Elias D, Blot F, El Otmany A, Antoun S, Lasser P, Boige V, Rougier P, Ducreux M. Curative treatment of peritoneal carcinomatosis arising from colorectal cancer by complete resection and intraperitoneal chemotherapy. Cancer. 2001 Jul 1;92(1):71-6. — View Citation

Graf W, Glimelius B, Påhlman L, Bergström R. Determinants of prognosis in advanced colorectal cancer. Eur J Cancer. 1991;27(9):1119-23. — View Citation

Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000 Sep 28;343(13):905-14. — View Citation

Shepherd NA, Baxter KJ, Love SB. The prognostic importance of peritoneal involvement in colonic cancer: a prospective evaluation. Gastroenterology. 1997 Apr;112(4):1096-102. — View Citation

Verwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003 Oct 15;21(20):3737-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		8 years	No
Secondary	progression free survival		8 years	No
Secondary	Time to secondary treatment		8 years	No
Secondary	Radical resectability		5 years	No
Secondary	Quality of life		7 years	No
Secondary	Health costs		8 years	No
Secondary	Side effects of treatment		6 years	Yes