Combined Anticancer Treatment of Advanced Colon Cancer (COMBATAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Regensburg
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Pompiliu Piso, Prof. MD, University of Regensburg
ClinicalTrials.gov Identifier:
NCT01540344
First received: February 19, 2012
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Peritoneal Carcinomatosis
Colorectal Cancer Metastatic
Procedure: CRS
Drug: HIPEC
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Feasibility of the combined treatment concept [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Assessment of tumor progression, AE and SAE during treatment phase leading to modification or end of treatment.

  • Quality of life (QoL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    assessed by EORTC-QLQ-C30

  • Pathohistological regression [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    assessed by Dworak grade of regression in histology after surgery


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Hyperthermic intraperitoneal chemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540344

Contacts
Contact: Pompiliu Piso, Prof. MD 0049 941 369 ext 2201 pompiliu.piso@barmherzige-regensburg.de
Contact: Gabriel Glockzin, MD 0049 941 944 ext 0 gabriel.glockzin@ukr.de

Locations
Germany
Charité Campus Mitte, Humboldt-University Berlin Recruiting
Berlin, Germany, 10117
Contact: Beate Rau, Prof. MD       beate.rau@charite.de   
Principal Investigator: Beate Rau, Prof. MD         
Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg Recruiting
Erlangen, Germany, 91054
Contact: Roland Croner, MD       roland.croner@uk-erlangen.de   
Principal Investigator: Roland Croner, MD         
Hospital of the Henriettenstiftung Hannover Active, not recruiting
Hannover, Germany, 30171
Cologne-Merheim Medical Center, University Witten/Herdecke Recruiting
Koeln, Germany, 51058
Contact: Michael Stroehlein, MD       StroehleinM@kliniken-koeln.de   
Principal Investigator: Michael Stroehlein, MD         
University Medical Center Regensburg Recruiting
Regensburg, Germany, 93042
Contact: Gabriel Glockzin, MD       gabriel.glockzin@ukr.de   
Principal Investigator: Gabriel Glockzin, MD         
St. John of God Hospital Regensburg Recruiting
Regensburg, Germany, 93049
Contact: Pompiliu Piso, Prof. MD       pompiliu.piso@barmherzige-regensburg.de   
Principal Investigator: Pompiliu Piso, Prof. MD         
University Hospital, University of Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Stefan Beckert, PD MD       stefan.beckert@med.uni-tuebingen.de   
Principal Investigator: Stefan Beckert, PD MD         
University Hospital Wuerzburg, Julius-Maximilians University Recruiting
Wuerzburg, Germany, 97080
Contact: Joerg Pelz, MD       Pelz_J@chirurgie.uni-wuerzburg.de   
Principal Investigator: Joerg Pelz, MD         
Sponsors and Collaborators
University of Regensburg
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Pompiliu Piso, Prof. MD University of Regensburg
  More Information

Publications:
Responsible Party: Pompiliu Piso, Prof. MD, Principal Investigator, University of Regensburg
ClinicalTrials.gov Identifier: NCT01540344     History of Changes
Other Study ID Numbers: 24/06/2009, 2009-014040-11
Study First Received: February 19, 2012
Last Updated: February 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:
peritoneal carcinomatosis
cytoreductive surgery
HIPEC
colorectal cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Carcinoma
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 26, 2014