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Head and Neck Cancer Squamous CellPhase 2NCT01237483

Reirradiation and Erbitux in the HNSCC

A Phase 2 study testing Erbitux in people with Head and Neck Cancer Squamous Cell, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 ®. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Cancer Squamous Cell
What is being tested?
Erbitux
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
Oct 2010to 5 Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.,
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  • 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

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Bretonneau

    Tours, 37044

Other trials in France

About this study

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 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.

Being tested
Erbitux
Keywords
reirradiation with Erbitux, HNSCC, local recurrent inoperable Squamous Cell Cancer of the Head and Neck
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErbituxDrug

    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)

Study groups in NCT01237483
Study groupRoleWhat they receive
Erbitux RadiotherapyOtherRadiotherapy during 5 weeks and concurrent Erbitux once a week.
Receives: Drug: Erbitux

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The main objective is to evaluate the complete response rate of the association re-irradiation - Erbitux ®.

    Measured: It will be measured by spiral CT scan or magnetic resonance imaging (MRI), 2 months after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJul 2016
  4. Study completion5 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01237483
Sponsor's protocol ID
GORTEC 2008-01
Status last verified
Oct 2017
First submitted
8 Nov 2010
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erbitux in people with Head and Neck Cancer Squamous Cell, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01237483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.

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