Reirradiation and Erbitux in the HNSCC

NCT01237483 | Completed Phase 2 DMC

• 1 other identifier: GORTEC 2008-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer Squamous Cell

Keywords

reirradiation with Erbitux; HNSCC; local recurrent inoperable Squamous Cell Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Erbitux Radiotherapy

OTHER

Radiotherapy during 5 weeks and concurrent Erbitux once a week.

Drug: Erbitux

Interventions

Erbitux DRUG

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)

Erbitux Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead

Study Sites (1)

Hôpital Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Laurent MARTIN, oncologist

  Centre Guillaume Le Conquérant, 76600 Le Havre, France

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 5, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

FR (1)