To determine the optimal therapy for patients with pT1-2 pN0 oral and oropharyngeal cancer
ID
Source
Brief title
Condition
- Metastases
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
5-year survival
Secondary outcome
Recurrence of tumour (local, regional, distant)
Quality of life
Treatment Costs
Background summary
No unanimous therapy advice exists for pT1-T2 oral and oropharyngeal cancers
with a single neck-nodal metastasis (pN1). Until now postoperative irradiation
is considered facultative.
Irradiation might improve 5-years survival but deteriorates quality of life
Study objective
To determine the optimal therapy for patients with pT1-2 pN0 oral and
oropharyngeal cancer
Study design
Multi-centre (Europe) open 2-arm prospective randomised
Intervention
Postoperative Irradiation of the neck
Study burden and risks
Non-radiation arm : possible higher risk of tumour recurrence
Irradiation-Arm: 30 radiation-sessions with known adverse effects short-term (
dermatitis and mucositis) and long term ( fibrosis, higher risk of regional
infection)
heidelberglaan 100
3508GA Utrecht
NL
heidelberglaan 100
3508GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
pT1/T2 oral or oropharyngeal cancer
pN1 nodal metastasis
Complete surgical resection
Patient agreement
Karnovsky > 50
Exclusion criteria
Pregnancy
< 18 years
Karnovsky <50
legally incapable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16090.041.07 |