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Seven days a week postoperative radiotherapy versus postoperative radiochemotherapy in cancer of the oral cavity or oropharynx

Randomized clinical trial on seven days a week postoperative radiotherapy versus postoperative radiochemotherapy in locally advanced cancer of the oral cavity or oropharynx

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65457367
Enrollment
270
Registered
2011-08-31
Start date
2011-09-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous-cell cancer of the oral cavity or oropharynx Cancer Malignant neoplasm of oropharynx

Interventions

Patients will have to be appointed for radiotherapy shortly after the surgery, i.e. as soon as the pathological specimens are evaluated. Postoperative radiotherapy will begin as soon as posible, i.e a
the assigned treatments will differ, however, with respect to the overall radiation treatment time: it will be 5 weeks in p-CAIR and 7 weeks in p-RTCT. The total dose at sites considered to be at inte

Sponsors

Polish Ministry of Science and Higher Education (Poland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Squamous-cell cancer of the oral cavity or oropharynx 2. Age at least 18 years 3. A written informed consent for participation in a trial 4. Macroscopically complete major surgery 5. Good performance status (ZUBROD 0-1) 6. White-cell count of at least 3500 per cubic millimeter 7. Platelet count of at least 100,000 per cubic millimeter 8. Creatinine clearence of more than 50 ml per minute 9. Aminotransferase and bilirubin values below twice the normal upper limit

Exclusion criteria

Exclusion criteria: 1. Patients after reconstructive surgery with free-style flaps 2. Patients with stage pT1N0 disease 3. History of invasive cancer (except for nonmelanoma skin cancer) 4. Prior treatment 5. Distant metastases 6. For female participants, pregnant

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of locoregional recurrence

Secondary

MeasureTime frame
Local control, nodal control, metastases-free survival, disease-free survival, second cancer free survival, overall survival, acute mucosal reaction score (Dische system), acute radiation and hematological morbidity (RTOG scoring system), late radiation morbidity (RTOG/EORTC scoring system)

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026