Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
28/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl

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

Publication citations

Additional files

Editorial Notes