search
Back to results

Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

Primary Purpose

Colorectal Peritoneal Carcinomatosis

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)
Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Peritoneal Carcinomatosis focused on measuring colorectal cancer, cytoreductive surgery, intraperitoneal chemotherapy, systemic chemotherapy, Peritoneal Metastatic Disease From the Colon or Rectum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Akademiska Sjukhuset (Uppsala University Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: CRS plus postop intraperitoneal chemotherapy.

Arm B: Systemic chemotherapy alone

Arm Description

Cytoreductive surgery and postoperative intraperitoneal chemotherapy.

Systemic chemotherapy alone

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

progression free survival
Time to secondary treatment
Radical resectability
Quality of life
Health costs
Side effects of treatment

Full Information

First Posted
January 18, 2012
Last Updated
January 31, 2012
Sponsor
Uppsala University
search

1. Study Identification

Unique Protocol Identification Number
NCT01524094
Brief Title
Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis
Official Title
A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Peritoneal Carcinomatosis
Keywords
colorectal cancer, cytoreductive surgery, intraperitoneal chemotherapy, systemic chemotherapy, Peritoneal Metastatic Disease From the Colon or Rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: CRS plus postop intraperitoneal chemotherapy.
Arm Type
Experimental
Arm Description
Cytoreductive surgery and postoperative intraperitoneal chemotherapy.
Arm Title
Arm B: Systemic chemotherapy alone
Arm Type
Active Comparator
Arm Description
Systemic chemotherapy alone
Intervention Type
Drug
Intervention Name(s)
Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
Intervention Description
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 Outcome Measure Information:
Title
Overall survival
Time Frame
8 years
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
8 years
Title
Time to secondary treatment
Time Frame
8 years
Title
Radical resectability
Time Frame
5 years
Title
Quality of life
Time Frame
7 years
Title
Health costs
Time Frame
8 years
Title
Side effects of treatment
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilhelm Graf, M.D. Ph.D
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akademiska Sjukhuset (Uppsala University Hospital)
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
14551293
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. doi: 10.1200/JCO.2003.04.187.
Results Reference
background
PubMed Identifier
10206296
Citation
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. doi: 10.1038/sj.bjc.6690287.
Results Reference
background
PubMed Identifier
9097991
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. doi: 10.1016/s0016-5085(97)70119-7.
Results Reference
background
PubMed Identifier
1835620
Citation
Graf W, Glimelius B, Pahlman L, Bergstrom R. Determinants of prognosis in advanced colorectal cancer. Eur J Cancer. 1991;27(9):1119-23. doi: 10.1016/0277-5379(91)90307-y.
Results Reference
background
PubMed Identifier
11443611
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. doi: 10.1002/1097-0142(20010701)92:13.0.co;2-9.
Results Reference
background
PubMed Identifier
11006366
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. doi: 10.1056/NEJM200009283431302.
Results Reference
background
PubMed Identifier
26751236
Citation
Cashin PH, Mahteme H, Spang N, Syk I, Frodin JE, Torkzad M, Glimelius B, Graf W. Cytoreductive surgery and intraperitoneal chemotherapy versus systemic chemotherapy for colorectal peritoneal metastases: A randomised trial. Eur J Cancer. 2016 Jan;53:155-62. doi: 10.1016/j.ejca.2015.09.017. Epub 2016 Jan 2.
Results Reference
derived

Learn more about this trial

Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

We'll reach out to this number within 24 hrs