Multicenter, open-label phase II trial on post-surgery chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck with high risk of locoregional recurrence. - ACCRA-H

Heinrich-Heine-Universität Düsseldorf0 sites0 target enrollmentOctober 8, 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: This trial includes Patients with locally advanced squamous cell carcinoma of the head and neck (SCCH&N). In SCCH administration of chemotherapy of 5-FU and Cisplatin is a standard therapy. Herel the additional administration of cetuximab and radiotherapy under prior tumor resection is tested. Both therapies are each authorised therapies. The safety and efficacy of the combined therapies, especially on locregional recurrence of squamous cell carcinoma, will be evaluated.
Sponsor: Heinrich-Heine-Universität Düsseldorf
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

October 8, 2007

End Date

July 9, 2013

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-written informed consent
•\- Male or female patients between 18 and 70 years
•\-Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than maximum 9 weeks ago
•\-To be categorized as high risk, patients have to fulfil at least one of the following criterias: (R0 \- resection \<5 mm margin or R1 – resection or Extracapsular nodal extension)
•\-No previous chemotherapy and/or radiotherapy for carcinoma of the head and neck
•\-Performance status ECOG: 0 – 1
•\-Contraception in female partners of male patients and female patients with willingness to use effective contraceptive method for the study duration and 2 months post\-dosing
•\-Adequate renal, liver and hematological functions within 9 weeks until surgery:
•(\-Adequate bone marrow function: neutrophils \> 1\.5 x 10e9/L, platelets \> 100 x 10e9/L, hemoglobin \> 10\.0 g/dL;\-Adequate liver function: Bilirubin \< 2\.0 mg/dL, AST, ALT, AP, ?\-GT \< 3 x ULN)
•\-Adequate renal function: creatinine clearance \> 60 ml/min

•\-Nasopharyngeal carcinoma
•\-R2\-resection
•\-Invalid informed consent
•\-Performance Status \> 1
•\-Previous chemotherapy or radiotherapy for carcinoma of the head and neck
•\-Prior exposure to EGFR pathway targeting therapy
•\- Other serious illness or medical conditions:(\-Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4 or \-Clinically significantly abnormal electrocardio\-gram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal or\-Significant neurologic or psychiatric disorders including dementia or seizures or\-Active uncontrolled infection or \-Active disse\-minated intravascular coagulation or\- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study)
•\-Symptomatic peripheral neuropathy National Cancer Institute\-Common Toxicity Criteria (NCI\-CTC v3\.0\) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass
•\-Having participated in another therapeutic clinical trial or any investigational agent in the preceding 30 days;
•\-Known allergic/hypersensitivity reaction to any of the components of the treatment