Contact information
Type
Scientific
Primary contact
Prof J A Langendijk
ORCID ID
Contact details
Groningen University Medical Centre
Head Department Radiotherapie
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 361 1190
j.a.langendijk@umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR310; CKTO 2003-11
Study information
Scientific title
Conventionally fractionated versus accelerated postoperative radiotherapy in squamous cell carcinoma of the head and neck (SCCHC): a phase III randomised study
Acronym
POPART
Study hypothesis
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
Received from the local ethics committee
Study design
Multicentre randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/12/2003
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350
Participant 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
Recruitment start date
01/12/2003
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Groningen University Medical Centre
Groningen
9713 GZ
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary