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Reirradiation and Erbitux in the HNSCC

Primary Purpose

Head and Neck Cancer Squamous Cell

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Erbitux

About this trial

This is an interventional treatment trial for Head and Neck Cancer Squamous Cell focused on measuring reirradiation with Erbitux, HNSCC, local recurrent inoperable Squamous Cell Cancer of the Head and Neck

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Bretonneau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Erbitux Radiotherapy

Arm Description

Radiotherapy during 5 weeks and concurrent Erbitux once a week.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01237483

First Posted

November 8, 2010

Last Updated

October 25, 2017

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

1. Study Identification

Unique Protocol Identification Number

NCT01237483

Brief Title

Reirradiation and Erbitux in the HNSCC

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

October 2010 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer Squamous Cell

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Erbitux Radiotherapy

Arm Type

Other

Arm Description

Radiotherapy during 5 weeks and concurrent Erbitux once a week.

Intervention Type

Drug

Intervention Name(s)

Erbitux

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: