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Combined Anticancer Treatment of Advanced Colon Cancer (COMBATAC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Pompiliu Piso, Prof. MD, University of Regensburg.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540344
First Posted: February 28, 2012
Last Update Posted: December 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Pompiliu Piso, Prof. MD, University of Regensburg
  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: Intervention Model: Single Group Assignment
Masking: None (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 Pompiliu Piso, Prof. MD, University of Regensburg:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 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.

  • Quality of life (QoL) [ Time Frame: 2 years ]
    assessed by EORTC-QLQ-C30

  • Pathohistological regression [ Time Frame: 16 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540344


Locations
Germany
Charité Campus Mitte, Humboldt-University Berlin
Berlin, Germany, 10117
Medical Center of the Friedrich-Alexander-University Erlangen- Nürnberg
Erlangen, Germany, 91054
Cologne-Merheim Medical Center, University Witten/Herdecke
Koeln, Germany, 51058
University Hospital Regensburg
Regensburg, Germany, 93042
St. John of God Hospital Regensburg
Regensburg, Germany, 93049
University Hospital, University of Tuebingen
Tuebingen, Germany, 72076
University Hospital Wuerzburg, Julius-Maximilians University
Wuerzburg, Germany, 97080
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 ( EudraCT Number )
First Submitted: February 19, 2012
First Posted: February 28, 2012
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Pompiliu Piso, Prof. MD, University of Regensburg:
peritoneal carcinomatosis
cytoreductive surgery
HIPEC
colorectal cancer

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