Reirradiation and Erbitux in the HNSCC

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou (Other)

Overall Status

Completed

CT.gov ID

NCT01237483

Collaborator

(none)

Enrollment

Location

Arm

69.1

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Squamous Cell	Drug: Erbitux	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 5, 2016

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Bretonneau	Tours Cedex 09		France	37044

Sponsors and Collaborators

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