Reirradiation and Erbitux in the HNSCC
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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 |
|---|---|---|
|
Squamous Cell Cancer of the Head and Neck |
Drug: Erbitux Radiation: Radiotherapy |
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 |
- 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) |
-
Drug: Erbitux
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 |
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| 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 |
| 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 | |
| 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: | France NGUYEN, 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 | Centre Hospitalier de Bretagne Sud, 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: | Ali HASBINI, oncologist | Clinique Armoricaine de Radiologie, 22015 St Brieuc, France |
| Principal Investigator: | Olivier GALLOCHER, oncologist | Clinique Pasteur, 31300 Toulouse, France |
| Principal Investigator: | Olivier GALLOCHER, oncogist | Polyclinique du Parc, 31078 Toulouse, France |
| Principal Investigator: | Jean BOURHIS, oncologist | Institut Gustave Roussy, 94805 Villejuif, France |
More Information
No publications provided
| Responsible Party: | Laurent MARTIN/Oncologist and Radiation oncologist, Coordinator investigator |
| ClinicalTrials.gov Identifier: | NCT01237483 History of Changes |
| Other Study ID Numbers: | GORTEC 2008-01 |
| Study First Received: | November 8, 2010 |
| Last Updated: | June 23, 2011 |
| 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 Neoplasms, Squamous Cell Head and Neck Neoplasms 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 June 13, 2013