Clinical trial · Interventional
Reirradiation and Erbitux in the HNSCC
A Phase II Study, Multicenter, to Evaluate the Efficacy and Safety of the Combination of Reirradiation - Erbitux in Subjects Previously Irradiated and With a Local Recurrent Inoperable Squamous Cell Cancer of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer Squamous Cell | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erbitux | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Erbitux Radiotherapy
- description
- Radiotherapy during 5 weeks and concurrent Erbitux once a week.
- interventionNames
- Drug: Erbitux
Primary outcomes (1)
- measure
- The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®.
- timeFrame
- It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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