Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer

NCT00791141 | Completed Phase 2 DMC

• 1 other identifier: ACCRA-HN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief Summary

This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Radiation therapy; Chemotherapy; Chemoradiotherapy; adjuvant cetuximab administration

Outcome Measures

Primary Outcomes (1)

• Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.

  any toxicities occurring within 90 days post radiation start

Secondary Outcomes (6)

• Incidence of Loco-regional relapse

  assessment after patient has completed follow-up

• Disease-free survival

  time from start of surgery to the first evidence of loco-regional or distant tumor relapse or death

• Progression-free survival

  from start of surgery to the first observation of disease progression or death

• Overall survival

  censored at the time of last documented efficacy

• The rate of patients with secondary primary neoplasm

  assessment after patient has completed follow-up

Study Arms (1)

Cetuximab

EXPERIMENTAL

Cetuximab in combination with radiotherapy, cisplatin and 5-FU. After chemoradiotherapy all patients receive a cetuximab maintenance therapy.

Drug: Cetuximab

Interventions

Cetuximab DRUG

Loading dose prior to chemoradiotherapy 400 mg/m², followed by every week infusion of 250 mg/m² during chemoradiotherapy. After chemoradiotherapy every 2 week infusions of 500 mg/m² over 6 months.

Also known as: Erbitux

Cetuximab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• Males or females between 18 and 70 years of age;
• Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks (maximum) ago;
• To be categorized as high risk patients have to fulfil at least one of the following criteria:
• R0 - resection \<5 mm margin
• R1 - resection
• Extracapsular nodal extension;
• no previous chemotherapy, radiotherapy;
• Performance status ECOG: 0 - 1;
• Contraception in male and female patients if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing;
• Adequate renal, liver and hematological functions (within maximum 9 weeks until surgery):
• Adequate bone marrow function: neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 10.0 g/dL
• Adequate liver function: Bilirubin \< 2.0 mg/dL, AST, ALT, AP, γ-GT \< 3 x ULN
• Adequate renal function: creatinine clearance \> =60 ml/min
• No distant metastases;

You may not qualify if:

• 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;
• Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal
• Significant neurologic or psychiatric disorders including dementia or seizures;
• Active uncontrolled infection;
• Active disseminated intravascular coagulation;
• 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;

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (10)

Department of Radiotherapeutics of the University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Department of Radiological Oncology University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Department of Radiotherapy and Radiological Oncology University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Department of Radiotherapy and Radiological Oncology University Hospital Ulm

Ulm, Baden-Wurttemberg, 89091, Germany

Location

Department of Radiotherapy and Radiological Oncology, University Hospital Munich

Munich, Bavaria, 81377, Germany

Location

Department of Radiotherapy an Radiological Oncology University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Department of Radiotherapy and Radiological Oncology University Hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Department of Radiotherapy, University Hospital Schleswig Holstein, Campus Lübeck

Lübeck, Schleswig Hostein, 23538, Germany

Location

Charité University Medicine, Department of Radiotherapy and Radiological Oncology

Berlin, State of Berlin, 13353, Germany

Location

Department of Radiotherapy and Radiological Oncology Universität Hospital Jena

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

• Budach W, Bolke E, Homey B. Severe cutaneous reaction during radiation therapy with concurrent cetuximab. N Engl J Med. 2007 Aug 2;357(5):514-5. doi: 10.1056/NEJMc071075. No abstract available.

  PMID: 17671265 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wilfried Budach, Prof. Dr.

  Department of Radiotherapy and Radiological Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

DE (10)