Combined Anticancer Treatment of Advanced Colon Cancer (COMBATAC)
This study is currently recruiting participants.
Verified February 2013 by University of Regensburg
Sponsor:
University of Regensburg
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
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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
|
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
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 Neoplasms, Second Primary 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 May 22, 2013