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

ISRCTN	ISRCTN72086307
DOI	https://doi.org/10.1186/ISRCTN72086307
Secondary identifying numbers	NTR310; CKTO 2003-11

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 28/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J A Langendijk
Scientific

Groningen University Medical Centre
Head Department Radiotherapie
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone	+31 (0)50 361 1190
Email	j.a.langendijk@umcg.nl

Study information

Study design	Multicentre randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Conventionally fractionated versus accelerated postoperative radiotherapy in squamous cell carcinoma of the head and neck (SCCHC): a phase III randomised study
Study acronym	POPART
Study objectives	Test in a phase III randomised study whether an improvement of loco-regional control can be obtained with accelerated post-operative 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.
Ethics approval(s)	Received from the local ethics committee
Health condition(s) or problem(s) studied	Squamous cell carcinoma, oral cavity, oropharynx, hypopharynx, larynx
Intervention	Accelerated post-operative radiotherapy (66 Gy in 5 weeks) as compared to conventionally fractionated radiotherapy (66 Gy in 7 weeks). Other joint sponsors: 1. University Medical Centre Groningen (UMCG) (Netherlands) 2. Integrated Cancer Centre Amsterdam (Integraal Kankercentrum Amsterdam [IKA]) (Netherlands)
Intervention type	Other
Primary outcome measure	Loco-regional control.
Secondary outcome measures	1. Distant metastases 2. Disease free survival 3. Overall survival 4. Quality of life 5. Acute morbidity 6. Late morbidity 7. Cost-effectiveness
Overall study start date	01/12/2003
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	350
Key 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
Key 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
Date of first enrolment	01/12/2003
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Groningen University Medical Centre

Groningen
9713 GZ
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Website	http://www.vumc.nl
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Charity

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan