NCT01524094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

7.5 years

First QC Date

January 18, 2012

Last Update Submit

January 31, 2012

Conditions

Colorectal Peritoneal Carcinomatosis

Keywords

colorectal cancercytoreductive surgeryintraperitoneal chemotherapysystemic chemotherapyPeritoneal Metastatic Disease From the Colon or Rectum

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    8 years

Secondary Outcomes (6)

  • progression free survival

    8 years

  • Time to secondary treatment

    8 years

  • Radical resectability

    5 years

  • Quality of life

    7 years

  • Health costs

    8 years

  • +1 more secondary outcomes

Study Arms (2)

Arm A: CRS plus postop intraperitoneal chemotherapy.

EXPERIMENTAL

Cytoreductive surgery and postoperative intraperitoneal chemotherapy.

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

Arm B: Systemic chemotherapy alone

ACTIVE COMPARATOR

Systemic chemotherapy alone

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

Interventions

Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)DRUG

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.

Arm B: Systemic chemotherapy alone
Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)PROCEDURE

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.

Arm A: CRS plus postop intraperitoneal chemotherapy.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademiska Sjukhuset (Uppsala University Hospital)

Uppsala, SE-751 85, Sweden

Location

Related Publications (7)

  • 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.

    PMID: 14551293BACKGROUND

  • 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.

    PMID: 10206296BACKGROUND

  • 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.

    PMID: 9097991BACKGROUND

  • 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.

    PMID: 1835620BACKGROUND

  • 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.

    PMID: 11443611BACKGROUND

  • 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.

    PMID: 11006366BACKGROUND

  • 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.

    PMID: 26751236DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

OxaliplatinFluorouracilLeucovorinCytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesSurgical Procedures, Operative

Study Officials

  • Wilhelm Graf, M.D. Ph.D

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD.

Study Record Dates

First Submitted

January 18, 2012

First Posted

February 1, 2012

Study Start

June 1, 2003

Primary Completion

December 1, 2010

Study Completion

January 1, 2012

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

SE(1)