Clinical trial NCT01237483: Reirradiation and Erbitux in the HNSCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer Squamous Cell
Keywords: reirradiation with Erbitux
HNSCC
local recurrent inoperable Squamous Cell Cancer of the Head and Neck
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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.

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Tours Cedex 09
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Centre Guillaume Le Conquérant, 76600 Le Havre, France
name: Laurent MARTIN, oncologist
role: STUDY_DIRECTOR
affiliation: Centre Paul Papin, 49933 Angers, France
name: Claude TUCHAIS, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Sainte Catherine, 84082 Avignon, France
name: Sauveur Marc ALFONSI, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Jean Minoz, 25030 Besançon, France
name: Xu Sh SUN, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre François Baclesse, 14076 Caen, France
name: Dominique DE RAUCOURT, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jean Perrin, 63011 Clermond-Ferrand, France
name: Michel LAPEYRE, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre G-F Leclerc, 21079 Dijon, France
name: Philippe MAINGON, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Robert Boulin, 33505 Libourne, France
name: Muriel GARCIA-RAMIREZ, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital du Scorff, 56322 Lorient, France
name: Christian SIRE, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Léon Bérard, 69373 Lyon, France
name: Séverine RACADOT, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Lyon Sud, 69495 Pierre-Benite, France
name: Véronique FAVREL, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre René Gauducheau, 44805 Nantes-St Herblain, France
name: Etienne BARDET, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de La Pitié Salpitrière, 75013 Paris, France
name: Philippe LANG, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Henri Becquerel, 76038 Rouen, France
name: Isabelle TENNEVET, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Armoricaine de Radiologie, 22015 St Brieuc, France
name: Patricia BURBAN, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur, 31300 Toulouse, France
name: Olivier GALLOCHER, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Polyclinique du Parc, 31078 Toulouse, France
name: Olivier GALLOCHER, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Gustave Roussy, 94805 Villejuif, France
name: Yungan TAO, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Val d'Aurelle 34298 Montpellier cedex
name: Pierre BOISSELIER, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Antoine Lacassagne 06189 NICE cedex 2
name: Frédéric PEYRADE, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique de l' Estuaire 44600 Pornichet
name: Marie SALIOU, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jean Bernard 72000 Le Mans
name: Cédrik LAFOND, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU 86021 Poitiers cedex
name: René-Jean BENSADOUN, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens sud 80004 Amiens
name: Alexandre COUTTE, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU 86000 Limoges
name: Hao QIU, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Tenon 75020 Paris
name: Florence HUGUET, oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Paul Strauss 67065 Strasbourg
name: Sébastien GUIHARD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Belfort Montbéliard Bd du Maréchal Juin 25200 Montbéliard
name: Xu Shan SUN, oncologist
role: PRINCIPAL_INVESTIGATOR
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