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…
ID
Bron
Verkorte titel
Aandoening
Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Ondersteuning
Comprehensive Cancer Center Amsterdam (IKA)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Loco-regional control.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Accelerated postoperative radiotherapy (66 Gy in 5 weeks) as compared to conventionally fractionated radiotherapy (66 Gy in 7 weeks).
Publiek
Hanzeplein 1
J.A. Langendijk
Groningen 9713 GZ
The Netherlands
+31 (0)50 3611190
j.a.langendijk@umcg.nl
Wetenschappelijk
Hanzeplein 1
J.A. Langendijk
Groningen 9713 GZ
The Netherlands
+31 (0)50 3611190
j.a.langendijk@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL272 |
NTR-old | NTR310 |
Ander register | : N/A |
ISRCTN | ISRCTN72086307 |