Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract

NCT ID: NCT01211938

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-15
• Study Completion Date: 2017-02-25

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 begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of < 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)

Conditions

Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-fraction radiotherapy with concomitant 5FU and Hydrea

six 5-day cycles with a 9-day rest period between each cycle (split course). Each cycle includes : a single-fraction at a dose of 2 Gy per session for 5 sessions, combined with 5FU (800 mg/m2/day) and Hydrea (500 mg x 3/day) over the 5 days of the cycle. The total dose of radiotherapy is therefore 60 Gy delivered over 11 weeks.

Group Type: ACTIVE_COMPARATOR

single-fraction radiotherapy with concomitant 5FU and Hydrea

Intervention Type: RADIATION

single-fraction radiotherapy with concomitant 5FU and Hydrea

hyperfractionated radiotherapy with concomitant Cetuximab

Bifractionated radiotherapy at a dose of 1.2 Gy per session at a rate of 2 sessions per day, at least 6h apart, 5 days per week over 5 weeks, without a split course, combined with Cetuximab. The total dose of radiotherapy is 60 Gy delivered over 5 weeks. Cetuximab (ErbituxÒ) is to be administered in a 2-hour IV infusion at a dose of 400 mg/m2, 8 days before the start of radiotherapy, then in a 1-hour infusion at a dose of 250 mg/m2 on days 1, 8, 15, 22 and 29 of radiotherapy.

Group Type: EXPERIMENTAL

hyperfractionated radiotherapy with concomitant Cetuximab

Intervention Type: RADIATION

hyperfractionated radiotherapy with concomitant Cetuximab

Interventions

single-fraction radiotherapy with concomitant 5FU and Hydrea

single-fraction radiotherapy with concomitant 5FU and Hydrea

Intervention Type: RADIATION

hyperfractionated radiotherapy with concomitant Cetuximab

hyperfractionated radiotherapy with concomitant Cetuximab

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Gustave Roussy

Villejuif, , France

Countries

France

Related Links

http://www.gustaveroussy.fr/fr/essai/cancers-orl-cancer-6

ORL clinical trials on line in Institut Gustave Roussy

Other Identifiers

2009-017047-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSET 1542-JANORL2

Identifier Type: -

Identifier Source: org_study_id