Combined Anticancer Treatment of Advanced Colon Cancer (COMBATAC)

University of Regensburg (UR)

Status and phase

Terminated

Phase 2

Conditions

Colorectal Cancer Metastatic

Peritoneal Carcinomatosis

Treatments

Procedure: CRS

Drug: HIPEC

Study type

Interventional

Funder types

Other

Identifiers

NCT01540344

2009-014040-11 (EudraCT Number)

24/06/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 71 years old

Volunteers

No 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