Reirradiation and Erbitux in the HNSCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Groupe Oncologie Radiotherapie Tete et Cou
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01237483
First received: November 8, 2010
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Head Neck Cancer Squamous Cell.
Drug: Erbitux
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®. [ Time Frame: It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: October 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237483

Contacts
Contact: Delphine BRACONNIER, CRA (0)2 47 47 91 21 ext +33 delphine.braconnier@univ-tours.fr
Contact: Marie-Hélène CALAIS, CRA (0)2 47 47 91 21 ext +33 rc.corad@chu-tours.fr

Locations
France
Hôpital Bretonneau Recruiting
Tours Cedex 09, France, 37044
Contact: Delphine BRACONNIER, CRA    (0)2 47 47 91 21 ext +33    delphine.braconnier@univ-tours.fr   
Contact: Laurent MARTIN, Coordinator Investigator    (0)2 35 13 66 13 ext +33    l.martin.oncorad-lehavre@orange.fr   
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
  More Information

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01237483     History of Changes
Other Study ID Numbers: GORTEC 2008-01
Study First Received: November 8, 2010
Last Updated: August 12, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
reirradiation with Erbitux
HNSCC
local recurrent inoperable Squamous Cell Cancer of the Head and Neck

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014