Clinical trial NCT01524094: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Peritoneal Carcinomatosis
Keywords: colorectal cancer
cytoreductive surgery
intraperitoneal chemotherapy
systemic chemotherapy
Peritoneal Metastatic Disease From the Colon or Rectum
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: 8 years
Secondary outcomes:
measure: progression free survival
timeFrame: 8 years
measure: Time to secondary treatment
timeFrame: 8 years
measure: Radical resectability
timeFrame: 5 years
measure: Quality of life
timeFrame: 7 years
measure: Health costs
timeFrame: 8 years
measure: Side effects of treatment
timeFrame: 6 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset (Uppsala University Hospital)
Study officials:
affiliation: Uppsala University
name: Wilhelm Graf, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.