Evaluation of a combined anticancer treatment consisting of pre- and postoperative intravenous polychemotherapy, extensive tumor surgery and heated intraabdominal chemotherapy in patients with peritoneal spread of colonic cancer

Phase 1

• Conditions: Synchronous or metachronous peritoneal carcinomatosis (PC) from appendiceal or colorectal cancer; MedDRA version: 17.1Level: LLTClassification code 10068069Term: Peritoneal carcinomatosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-014040-11-DE
• Lead Sponsor: niversity of Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-01
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven wt-RAS colorectal or appendiceal adenocarcinoma
- Complete macroscopic cytoreduction (CCR-0/1)
- 3-12 cycles of systemic chemotherapy (FOPLFOX/FOLFIRI) including cetuximab as preoperative induction therapy
- Availability of CT scan prior to preoperative chmeotherapy allowing for sufficient response evaluation
- 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Incomplete cytoreduction, tumordebulking, palliative surgery
- Hematogenous metastasis including irresectable liver metastasis
- Chemotherapy or therapy with EGFR receptor antibody for metastatic disease prior to actual induction therapy
- RAS mutation (exon 2,3 and 4 or KRAS and NRAS) or unknown RAS statuts
- Known allergy to murine or chimeric monoclonal antibodies
- Histology of signet ring carcinoma (> 20%)
- Other malignancy than disease under study / second cancer < 5 years after R0 resection
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified