NCT01540344

Brief Summary

The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising from colorectal cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

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

October 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

February 19, 2012

Last Update Submit

August 31, 2018

Conditions

Peritoneal CarcinomatosisColorectal Cancer Metastatic

Keywords

peritoneal carcinomatosiscytoreductive surgeryHIPECcolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    24 months

Secondary Outcomes (4)

  • Overall survival (OS)

    5 years

  • Feasibility of the combined treatment concept

    9 months

  • Quality of life (QoL)

    2 years

  • Pathohistological regression

    16 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

1. FOLFOX/FOLFIRI + cetuximab (6 cycles) 2. CRS and HIPEC 3. FOLFOX/FOLFIRI + cetuximab (6 cycles)

Procedure: CRSDrug: HIPEC

Interventions

CRSPROCEDURE

complete macroscopic cytoreduction (CC-0/1)

Also known as: Cytoreductive surgery
Treatment Arm
HIPECDRUG

bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) with 400 mg/sqm 5-FU + 20 mg/sqm folinic acid IV and 300 mg/sqm oxaliplatin IP

Also known as: Hyperthermic intraperitoneal chemotherapy
Treatment Arm

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven colorectal or appendiceal adenocarcinoma
  • Complete macroscopic cytoreduction (CCR-0/1)
  • Free treatment interval of at least 6 month after the last chemotherapy
  • Age over 18 and below 71 years
  • Good general health status (Karnofsky \> 70%, ECOG 0-2)
  • Absence of hematogenous metastasis (lung, bone, brain, \> 3 peripheric resectable liver metastases)
  • Absence of contraindication for systemic chemotherapy and/or extended surgery
  • Life expectancy greater than 6 months
  • Written informed consent
  • Creatinine clearance \> 50 ml/min, serum creatinine ≤ 1.5 x ULN
  • Serum bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN
  • Platelet count \> 100,000 /ml, haemoglobin \> 9 g/dl, neutrophile granulocytes ≥ 1,500 /ml, International Normalized Ration (INR) ≤ 2
  • Absence of peripheral neuropathy \> grade 1 (CTCAE v4.0)
  • No pregnancy or breast feeding. Adequate contraception in fertile patients.

You may not qualify if:

  • Incomplete cytoreduction
  • Hematogenous metastasis including irresectable liver metastasis
  • Prior chemotherapy or therapy with EGFR receptor antibody for metastatic disease
  • K-ras mutation
  • Known allergy to murine or chimeric monoclonal antibodies
  • Histology of signet ring carcinoma
  • Other malignancy than disease under study / second cancer
  • Heart failure NYHA ≥ 2 or significant Coronary Artery Disease
  • Alcohol and/or drug abuse
  • Patients unable or unwilling to comply with the study protocol, treatment or follow-up
  • Patients included in other clinical trials interfering with the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Charité Campus Mitte, Humboldt-University Berlin

Berlin, 10117, Germany

Location

Cologne-Merheim Medical Center, University Witten/Herdecke

Cologne, 51058, Germany

Location

Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg

Erlangen, 91054, Germany

Location

University Hospital Regensburg

Regensburg, 93042, Germany

Location

St. John of God Hospital Regensburg

Regensburg, 93049, Germany

Location

University Hospital, University of Tuebingen

Tübingen, 72076, Germany

Location

University Hospital Wuerzburg, Julius-Maximilians University

Würzburg, 97080, Germany

Location

Related Publications (2)

  • Glockzin G, Rochon J, Arnold D, Lang SA, Klebl F, Zeman F, Koller M, Schlitt HJ, Piso P. A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial. BMC Cancer. 2013 Feb 7;13:67. doi: 10.1186/1471-2407-13-67.

    PMID: 23391248BACKGROUND

  • Glockzin G, Zeman F, Croner RS, Konigsrainer A, Pelz J, Strohlein MA, Rau B, Arnold D, Koller M, Schlitt HJ, Piso P. Perioperative Systemic Chemotherapy, Cytoreductive Surgery, and Hyperthermic Intraperitoneal Chemotherapy in Patients With Colorectal Peritoneal Metastasis: Results of the Prospective Multicenter Phase 2 COMBATAC Trial. Clin Colorectal Cancer. 2018 Dec;17(4):285-296. doi: 10.1016/j.clcc.2018.07.011. Epub 2018 Jul 31.

    PMID: 30131226RESULT

MeSH Terms

Conditions

Peritoneal NeoplasmsColorectal Neoplasms

Interventions

Cytoreduction Surgical ProceduresHyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeChemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Pompiliu Piso, Prof. MD

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2012

First Posted

February 28, 2012

Study Start

October 1, 2010

Primary Completion

September 1, 2015

Study Completion

October 1, 2017

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations

DE(7)