Clinical trial · Interventional
Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis
A Randomised Phase-III Study Comparing Cytoreductive Surgery Plus Intraperitoneal Chemotherapy Versus Modern Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis.
NCT01524094CI-TRIAL-00006168completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Peritoneal Carcinomatosis | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin) | Procedure | — | UNRESOLVED |
| Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: CRS plus postop intraperitoneal chemotherapy.
- description
- Cytoreductive surgery and postoperative intraperitoneal chemotherapy.
- interventionNames
- Procedure: Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Systemic chemotherapy alone
- description
- Systemic chemotherapy alone
- interventionNames
- Drug: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDVerwaal 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. PMID 14551293
- BACKGROUNDAssersohn 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. PMID 10206296
- BACKGROUNDShepherd 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. PMID 9097991
- BACKGROUNDGraf 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. PMID 1835620
- BACKGROUNDElias 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. PMID 11443611
- BACKGROUNDSaltz 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. PMID 11006366
- DERIVEDCashin 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.