Reirradiation and Erbitux in the HNSCC

• Status: Completed
• Trial end date: 2016-07-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate in patients with cancer of the throat and recurrent inoperable a different modality treatment consisting of radiation continuously for 5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer, called Erbitux ®.

The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment) to improve the antitumor efficacy without additional toxic side effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Patient with unresectable locoregional recurrence of squamous cell carcinoma in a previously irradiated area (at least 75% of the volume of recidivism must be in an area who have received at least 50 Gy)

• The entire tumor volume can be included in a radiation field without the total dose to the spinal cord more than 50 Gy (dose + dose earlier predicted)

• Patient with recurrent or second location in the oral cavity, oropharynx, larynx, hypopharynx, cervical lymph nodes or tissues, without distant metastases,

• Minimum 12 months after the end of radiotherapy previous

• WHO performance status: 0-1,

• Evaluable disease by RECIST V.1.1.,

• Age between 18 and 75 years

• The patient may have received prior chemotherapy for relapse for more than five weeks,

• The patient may have received cetuximab for the treatment of disease but not for the first relapse,

• Hematologic function: ANC ≥ 1500/mm3, Platelets ≥ 100000/mm3,

• Normal renal function: serum creatinine ≤ 120 µmol/l and/or creatinine clearance > 60 ml/min

• Normal liver function: bilirubin <1.5 x ULN, alkaline phosphatase and transaminases <2.5 x ULN,

• Normal cardiac function, assessed clinically. History of cardiovascular disease stabilized for over 12 months

• Cons-Lack of medical indications in the proposed treatment,

• The dosimetry of previous treatment should be available and the estimated dosimetry must be performed to check the constraints,

• All patients of childbearing age should receive effective contraception,

• Membership of a social security system (or be a beneficiary of such a plan) under the terms of the Act of August 9, 2004,

• Signed informed consent

Exclusion Criteria:

• Tumors of the nasal cavity and paranasal,

• Tumors of other histological type,

• Stage IV with distant metastases or multiple tumors,

• Time after previous radiotherapy <12 months,

• Less than 75% of the volume of relapse who have previously received at least 50 Gy,

• Any medical condition or general-cons would indicate the completion of treatment. Systemic disease or uncontrolled infection,

• History of cancer other than head and neck cancer, cutaneous basal cell, carcinoma in situ of the cervix

• Any other concurrent anticancer therapy,

• Patient receiving another molecule experimental

• Pregnant, lactating or without contraception;

• Persons deprived of liberty under guardianship

• Inability to undergo medical test for geographical, social or psychological

• Nasopharyngeal Neoplasms

• Patients with active ischemic heart disease or previous myocardial infarction within the last 12 months

• Late toxicity dermal or subcutaneous related to previous irradiation of grade> 2 in the scale CTCAE V.4.