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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Squamous Cell Cancer of the Head and Neck

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Laurent MARTIN, oncologist

Investigator Role:

Study Director

Investigator Affiliation:

Centre Guillaume Le Conquérant, 76600 Le Havre, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GORTEC 2008-01

NCT ID:

NCT01237483

Start Date:

October 2010

Completion Date:

February 2015

Related Keywords:

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

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