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van CCT (UK)


Postoperative Accelerated RadioTherapy versus conventional radiotherapy in squamous cell head and neck cancer (POPART). A phase III randomised study.


- candidate number1509
- NTR NumberNTR310
- ISRCTNISRCTN72086307
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitlePostoperative Accelerated RadioTherapy versus conventional radiotherapy in squamous cell head and neck cancer (POPART). A phase III randomised study.
- Scientific TitleConventionally fractionated versus accelerated postoperative radiotherapy in SCCHC A phase III randomised study.
- ACRONYMPOPART, CKTO 2003-11
- hypothesisTest 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.
- Healt Condition(s) or Problem(s) studiedLaryngopharynx , Squamous cell carcinoma (SCC)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-dec-2003
- planned closingdate1-jan-2009
- Target number of participants350
- InterventionsAccelerated postoperative radiotherapy (66 Gy in 5 weeks) as compared to conventionally fractionated radiotherapy (66 Gy in 7 weeks).
- Primary outcomeLoco-regional control.
- Secondary outcome1. Distant metastases;
2. Disease free survival;
3. Overall survival;
4. Quality of life;
5. Acute morbidity,
6. Late morbidity;
7. Cost-effectiveness.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.A. Langendijk
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.A. Langendijk
- Sponsor/Initiator VU University Medical Center, University Medical Center Groningen (UMCG), Department of Radiotherapie, Comprehensive Cancer Center (IKA) Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-sep-2005 - 7-mrt-2006


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