Combined Anticancer Treatment of Advanced Colon Cancer (COMBATAC)

August 31, 2018 updated by: Pompiliu Piso, Prof. MD, University of Regensburg

Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

More than 10% of patients with colorectal cancer (CRC) already show peritoneal carcinomatosis at the time of initial diagnosis and up to 25% of all patients develop peritoneal carcinomatosis during the natural course of their disease as a common sign of tumor progression or recurrence.

The existing data suggests that CRS and HIPEC as an integral part of a multidisciplinary treatment concept may improve long-term survival of selected patients with peritoneal carcinomatosis of colonic origin. Moreover, hyperthermic peritoneal perfusion with oxaliplatin in combination with synchronous application of 5-FU/leucovorin seems to improve the efficacy of HIPEC in comparison to a mitomycin C-based intraperitoneal treatment regimen and may lead to a better local tumor control. The improved systemic treatment strategy with neoadjuvant chemotherapy may lead to increased rates of complete macroscopic cytoreduction and together with the adjuvant treatment to better control of distant metastasis and tumor recurrence. However, there is no prospective study available evaluating the clinical and oncological outcome after standard-of-care chemotherapy including targeted anticancer therapy in combination with CRS and HIPEC. The published morbidity and mortality rates after CRS and HIPEC are comparable to other major gastrointestinal surgery and seem to be acceptable considering the expected improvement of oncological outcome.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Campus Mitte, Humboldt-University Berlin
      • Erlangen, Germany, 91054
        • Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg
      • Koeln, Germany, 51058
        • Cologne-Merheim Medical Center, University Witten/Herdecke
      • Regensburg, Germany, 93042
        • University Hospital Regensburg
      • Regensburg, Germany, 93049
        • St. John of God Hospital Regensburg
      • Tuebingen, Germany, 72076
        • University Hospital, University of Tuebingen
      • Wuerzburg, Germany, 97080
        • University Hospital Wuerzburg, Julius-Maximilians University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Impaired liver, renal or hematologic function as mentioned above (inclusion criteria)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
  1. FOLFOX/FOLFIRI + cetuximab (6 cycles)
  2. CRS and HIPEC
  3. FOLFOX/FOLFIRI + cetuximab (6 cycles)
Procedure: CRS
complete macroscopic cytoreduction (CC-0/1)
Other Names:
  • Cytoreductive surgery
Drug: HIPEC
bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) with 400 mg/sqm 5-FU + 20 mg/sqm folinic acid IV and 300 mg/sqm oxaliplatin IP
Other Names:
  • Hyperthermic intraperitoneal chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years
5 years
Feasibility of the combined treatment concept
Time Frame: 9 months
Assessment of tumor progression, AE and SAE during treatment phase leading to modification or end of treatment.
9 months
Quality of life (QoL)
Time Frame: 2 years
assessed by EORTC-QLQ-C30
2 years
Pathohistological regression
Time Frame: 16 weeks
assessed by Dworak grade of regression in histology after surgery
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Pompiliu Piso, Prof. MD, University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

February 19, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (Estimate)

February 28, 2012

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24/06/2009
  • 2009-014040-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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