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Randomized Phase 2 Trial Evaluating the Acute Toxicity of Two Protocols of Reirradiation After Surgery in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract - Single-fraction Radiotherapy With Concomitant 5FU and Hydrea Administered Every Other Week - Continuous Hyperfractionated Radiotherapy With Concomitant Cetuximab


Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Squamous Cell Carcinoma

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Trial Information

Randomized Phase 2 Trial Evaluating the Acute Toxicity of Two Protocols of Reirradiation After Surgery in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract - Single-fraction Radiotherapy With Concomitant 5FU and Hydrea Administered Every Other Week - Continuous Hyperfractionated Radiotherapy With Concomitant Cetuximab


Inclusion Criteria:



- Recurrent or second upper aerodigestive tract carcinoma in an area previously
irradiated at a dose of >= 50 Gy

- Squamous cell carcinoma

- No grade III or IV sequels linked to the first radiation therapy (excepted radiation
sequels of salivary glands)

- Relapse or second carcinoma (clinically invasive and/or lymph node recurrence >= 3 cm
and/or the association of a local and lymph node recurrence

- Oral cavity, pharynx, larynx (if rT4), cervical region (if >3cm)

- No distant metastases confirmed by chest CT scan, abdominal ultrasound (or CT scan)
in case of abnormal liver function, and bone scintigraphy in case of local symptoms

- Surgery in the previously irradiated region allowing a macroscopically adequate
resection

- Surgery and vascular protection with a myocutaneous or free flap

- Interval > = 6 months between the end of the first radiation treatment and surgery in
the previously irradiated area

- Wound healing allowing reirradiation within an interval of 8 weeks after surgery in
the previouly irradiated area.

- No participation in a clinical trial during the 30 days preceding inclusion

- Age between 18 et 70 years.

- Performance Status 0 or 1 according to WHO criteria.

- Hematological function : neutrophils * 2 x 106/l, platelets : * 100 x 106/l,
hemoglobin : * 10 g/dl (or 6.2 mmol/l)

- Liver function : total bilirubin (normal) ; ASAT (SGOT) and ALAT (SGPT) * 2.5 * upper
limit of normal (ULN) in each centre ; alkaline phosphatases * 5 * ULN. Patients
whose ASAT or ALAT levels > 1.5 * ULN associated with alkaline phosphatases * 2.5 *
ULN are not eligible for the trial

- Renal function : serum creatinine * 120 *mol/l (1.4 mg/dl) ; if creatinine level is
> 120 *mol/l, creatinine clearance should be * 60 ml/min.

- Written consent of participants

Exclusion Criteria:

- Superficial recurrence not associated with a lymph node relapse, isolated lymph node
recurrence measuring less than 3 cm

- Distant metastases

- Grade 3 or 4 sequels of first radiation therapy (excepted salivary gland sequels)

- Macroscopically inadequate surgery

- Delay in wound healing obliging reirradiation to be postponed beyond 8 weeks.

- > Grade 3 Toxicity induced by chemotherapy administered during a previous treatment

- Hypersensitivity to Erbitux

- Concomitant severe comorbidities (non exhaustive list)

- Unstable cardiac comorbidity in spite of treatment.

- Neurological or psychiatric history such as dementia, convulsions.

- Severe uncontrolled infection

- Obstructive bronchopneumopathy which required hospitalisation during the year
preceding inclusion.

- Factors (psychological, familial, social or geographic) likely to hinder patient
compliance with the study protocol and follow-up are considered exclusion criteria.
These factors should be discussed with the patient before enrollment in the trial

- Women who are pregnant, breast-feeding or of birthgiving age without effective
contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute toxicity requiring an interruption of radiotherapy for more than 2 weeks

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

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

Study ID:

CSET 1542-JANORL2

NCT ID:

NCT01211938

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma
  • phase II/III
  • upper aerodigestive tract carcinoma
  • re irradiation
  • Recurrent or second upper aerodigestive tract carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell

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