Post-OPerative Accelerated RadioTherapy versus conventional radiotherapy in squamous cell head and neck cancer: a phase III randomised study

Completed

Conditions: Squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx
Cancer
Malignant neoplasm of other and ill-defined sites

Registration Number: ISRCTN72086307

Lead Sponsor: Vrije University Medical Centre (VUMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 350

Inclusion Criteria

1. Proper clinical evaluation must have been performed according to the national guidelines
2. Histologically proven squamous cell carcinoma (World Health Organisation [WHO] grade 1 - 3) of the oral cavity, oropharynx, hypopharynx or larynx (unknown primary excluded)
3. Primary surgery with curative intent
4. High risk for loco-regional recurrence, i.e. positive resection margins (less than 1 mm) and/or lymph node metastases with extranodal spread
5. Radiotherapy must start preferentially within 6 weeks but not later than 7 weeks after surgery
6. Previously untreated patients (except the surgery)
7. Age greater than 18 years, either sex
8. WHO performance status 0 - 2
9. Patients of reproductive potential must agree to practice an effective contraceptive method
10. Written informed consent

Exclusion Criteria

1. Macroscopic residual disease at the primary site and/or neck
2. Distant metastases
3. Previous malignancy except basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder cancer (pTa)
4. Previous induction chemotherapy, concurrent or adjuvant chemotherapy
5. Pregnant or lactating
6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oco-regional control.

Secondary Outcome Measures

Name	Time	Method
1. Distant metastases<br>2. Disease free survival<br>3. Overall survival<br>4. Quality of life <br>5. Acute morbidity<br>6. Late morbidity <br>7. Cost-effectiveness