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CompletedNCT01237483Updated Oct 26, 2017

Reirradiation and Erbitux in the HNSCC

A Phase 2 interventional study of Erbitux in Head and Neck Cancer Squamous Cell, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Cancer Squamous Cell

Keywords

  • reirradiation with Erbitux
  • HNSCC
  • local recurrent inoperable Squamous Cell Cancer of the Head and Neck
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 50 is close to the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Erbitux Radiotherapy

    Radiotherapy during 5 weeks and concurrent Erbitux once a week.

    Drug: Erbitux

Interventions

  • DrugErbitux

    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)

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Hôpital Bretonneau
    Tours Cedex 09, 37044, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01237483
Lead sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Responsible party
Sponsor
First posted
Nov 9, 2010
Start date
Oct 2010
Primary completion
Jul 2016
Completion
Jul 5, 2016
Last update
Oct 26, 2017

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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