Status:
COMPLETED
Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01211938
Start Date
June 15 2010
End Date
February 25 2017
Last Update
May 16 2017
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800