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 |
| Protocol serial number | NTR310; CKTO 2003-11 |
| Sponsor | Vrije University Medical Centre (VUMC) (Netherlands) |
| Funder | The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands) |
- 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
Scientific
Groningen University Medical Centre
Head Department Radiotherapie
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| Phone | +31 (0)50 361 1190 |
|---|---|
| j.a.langendijk@umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Loco-regional control. |
| Key secondary outcome measure(s) |
1. Distant metastases |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
9713 GZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
