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Combined Anticancer Treatment of Advanced Colon Cancer (COMBATAC)

Primary Purpose

Peritoneal Carcinomatosis, Colorectal Cancer Metastatic

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CRS
HIPEC
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Carcinomatosis focused on measuring peritoneal carcinomatosis, cytoreductive surgery, HIPEC, colorectal cancer

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Campus Mitte, Humboldt-University Berlin
  • Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg
  • Cologne-Merheim Medical Center, University Witten/Herdecke
  • University Hospital Regensburg
  • St. John of God Hospital Regensburg
  • University Hospital, University of Tuebingen
  • University Hospital Wuerzburg, Julius-Maximilians University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

FOLFOX/FOLFIRI + cetuximab (6 cycles) CRS and HIPEC FOLFOX/FOLFIRI + cetuximab (6 cycles)

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Overall survival (OS)
Feasibility of the combined treatment concept
Assessment of tumor progression, AE and SAE during treatment phase leading to modification or end of treatment.
Quality of life (QoL)
assessed by EORTC-QLQ-C30
Pathohistological regression
assessed by Dworak grade of regression in histology after surgery

Full Information

First Posted
February 19, 2012
Last Updated
August 31, 2018
Sponsor
University of Regensburg
Collaborators
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT01540344
Brief Title
Combined Anticancer Treatment of Advanced Colon Cancer
Acronym
COMBATAC
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment.
Study Start Date
October 2010 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
Collaborators
Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis, Colorectal Cancer Metastatic
Keywords
peritoneal carcinomatosis, cytoreductive surgery, HIPEC, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
FOLFOX/FOLFIRI + cetuximab (6 cycles) CRS and HIPEC FOLFOX/FOLFIRI + cetuximab (6 cycles)
Intervention Type
Procedure
Intervention Name(s)
CRS
Other Intervention Name(s)
Cytoreductive surgery
Intervention Description
complete macroscopic cytoreduction (CC-0/1)
Intervention Type
Drug
Intervention Name(s)
HIPEC
Other Intervention Name(s)
Hyperthermic intraperitoneal chemotherapy
Intervention Description
bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) with 400 mg/sqm 5-FU + 20 mg/sqm folinic acid IV and 300 mg/sqm oxaliplatin IP
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
5 years
Title
Feasibility of the combined treatment concept
Description
Assessment of tumor progression, AE and SAE during treatment phase leading to modification or end of treatment.
Time Frame
9 months
Title
Quality of life (QoL)
Description
assessed by EORTC-QLQ-C30
Time Frame
2 years
Title
Pathohistological regression
Description
assessed by Dworak grade of regression in histology after surgery
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pompiliu Piso, Prof. MD
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Campus Mitte, Humboldt-University Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Cologne-Merheim Medical Center, University Witten/Herdecke
City
Koeln
ZIP/Postal Code
51058
Country
Germany
Facility Name
University Hospital Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
St. John of God Hospital Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
University Hospital, University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Hospital Wuerzburg, Julius-Maximilians University
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23391248
Citation
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.
Results Reference
background
PubMed Identifier
30131226
Citation
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.
Results Reference
result

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Combined Anticancer Treatment of Advanced Colon Cancer

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