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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer Squamous Cell
• Intervention / Treatment: Drug: Erbitux

Detailed Description

We hope with this treatment improved antitumor efficacy without additional toxic side effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we can not meet the current state of knowledge, which justifies this study.

The main hypothesis is that this combination of reirradiation and Cetuximab give a relative gain of 15% complete response rate.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Tours Cedex 09, France, 37044
    • Hôpital Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Erbitux Radiotherapy; Radiotherapy during 5 weeks and concurrent Erbitux once a week.	Drug: Erbitux; To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®.	It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment

Collaborators and Investigators

• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Investigators: Study Director: Laurent MARTIN, oncologist, Centre Guillaume Le Conquérant, 76600 Le Havre, France; Principal Investigator: Claude TUCHAIS, oncologist, Centre Paul Papin, 49933 Angers, France; Principal Investigator: Sauveur Marc ALFONSI, oncologist, Institut Sainte Catherine, 84082 Avignon, France; Principal Investigator: Xu Sh SUN, oncologist, Hôpital Jean Minoz, 25030 Besançon, France; Principal Investigator: Dominique DE RAUCOURT, oncologist, Centre François Baclesse, 14076 Caen, France; Principal Investigator: Michel LAPEYRE, oncologist, Centre Jean Perrin, 63011 Clermond-Ferrand, France; Principal Investigator: Philippe MAINGON, oncologist, Centre G-F Leclerc, 21079 Dijon, France; Principal Investigator: Muriel GARCIA-RAMIREZ, oncologist, Hôpital Robert Boulin, 33505 Libourne, France; Principal Investigator: Christian SIRE, oncologist, Hôpital du Scorff, 56322 Lorient, France; Principal Investigator: Séverine RACADOT, oncologist, Centre Léon Bérard, 69373 Lyon, France; Principal Investigator: Véronique FAVREL, oncologist, Centre Hospitalier Lyon Sud, 69495 Pierre-Benite, France; Principal Investigator: Etienne BARDET, oncologist, Centre René Gauducheau, 44805 Nantes-St Herblain, France; Principal Investigator: Philippe LANG, oncologist, Hôpital de La Pitié Salpitrière, 75013 Paris, France; Principal Investigator: Isabelle TENNEVET, oncologist, Centre Henri Becquerel, 76038 Rouen, France; Principal Investigator: Patricia BURBAN, oncologist, Clinique Armoricaine de Radiologie, 22015 St Brieuc, France; Principal Investigator: Olivier GALLOCHER, oncologist, Clinique Pasteur, 31300 Toulouse, France; Principal Investigator: Olivier GALLOCHER, oncologist, Polyclinique du Parc, 31078 Toulouse, France; Principal Investigator: Yungan TAO, oncologist, Institut Gustave Roussy, 94805 Villejuif, France; Principal Investigator: Pierre BOISSELIER, oncologist, Val d'Aurelle 34298 Montpellier cedex; Principal Investigator: Frédéric PEYRADE, oncologist, Centre Antoine Lacassagne 06189 NICE cedex 2; Principal Investigator: Marie SALIOU, oncologist, Clinique de l' Estuaire 44600 Pornichet; Principal Investigator: Cédrik LAFOND, oncologist, Centre Jean Bernard 72000 Le Mans; Principal Investigator: René-Jean BENSADOUN, oncologist, CHU 86021 Poitiers cedex; Principal Investigator: Alexandre COUTTE, oncologist, CHU Amiens sud 80004 Amiens; Principal Investigator: Hao QIU, oncologist, CHU 86000 Limoges; Principal Investigator: Florence HUGUET, oncologist, Hôpital Tenon 75020 Paris; Principal Investigator: Sébastien GUIHARD, Centre Paul Strauss 67065 Strasbourg; Principal Investigator: Xu Shan SUN, oncologist, Centre Hospitalier de Belfort Montbéliard Bd du Maréchal Juin 25200 Montbéliard

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2010
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 5, 2016

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (ESTIMATE): November 9, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: HNSCC; reirradiation with Erbitux; local recurrent inoperable Squamous Cell Cancer of the Head and Neck
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: GORTEC 2008-01