Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Conditions
Interventions
Accelerated postoperative radiotherapy (66 Gy in 5 weeks) as compared to conventionally fractionated radiotherapy (66 Gy in 7 weeks).
Sponsors
VU University Medical Center / Groningen University Medical Center
Comprehensive Cancer Center Amsterdam (IKA)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Proper clinical evaluation must have been performed according to the national guidelines; 2. Histologically proven squamous cell carcinoma (WHO grade 1-3) of the oral cavity, oropharynx, hypopharynx or larynx (unknown primary excluded); 3. Primary surgery with curative intent high risk for loco-regional recurrence, i.e. positive resection margins ( 18 years; 7. WHO performance status 0-2 patients of reproductive potential must agree to practice an effective contraceptive method; 8. Written informed consent.
Exclusion criteria
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. pregnant or lactating; 5. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loco-regional control. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Distant metastases; 2. Disease free survival; 3. Overall survival; 4. Quality of life; 5. Acute morbidity, 6. Late morbidity; 7. Cost-effectiveness. | — |
Contacts
Public ContactJ.A. Langendijk
University Medical Center Groningen (UMCG), Department of Radiotherapy, Hanzeplein 1
Outcome results
None listed