No registrations found.
ID
Source
Brief title
Health condition
Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Sponsors and support
Comprehensive Cancer Center Amsterdam (IKA)
Intervention
Outcome measures
Primary outcome
Loco-regional control.
Secondary outcome
1. Distant metastases;
2. Disease free survival;
3. Overall survival;
4. Quality of life;
5. Acute morbidity,
6. Late morbidity;
7. Cost-effectiveness.
Background summary
N/A
Study objective
Test in a phase III randomised study whether an improvement of loco-regional control can be obtained with accelerated postoperative radiotherapy (66 Gy in 5 weeks) as compared to conventionally fractionated radiotherapy (66 Gy in 7 weeks) in patients who are at high or very high risk for loco-regional recurrence after primary surgery for squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and/or larynx.
Intervention
Accelerated postoperative radiotherapy (66 Gy in 5 weeks) as compared to conventionally fractionated radiotherapy (66 Gy in 7 weeks).
Hanzeplein 1
J.A. Langendijk
Groningen 9713 GZ
The Netherlands
+31 (0)50 3611190
j.a.langendijk@umcg.nl
Hanzeplein 1
J.A. Langendijk
Groningen 9713 GZ
The Netherlands
+31 (0)50 3611190
j.a.langendijk@umcg.nl
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 (< 1 mm) and/or lymph node metastases with extranodal spread;
4. Radiotherapy must start preferentially within 6 weeks but not later than 7 weeks after surgery;
5. Previously untreated patients (except the surgery);
6. Age > 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL272 |
NTR-old | NTR310 |
Other | : N/A |
ISRCTN | ISRCTN72086307 |