Clinical trial · Interventional
Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer
The Accelerate Trial: Phase II Study Exploring Five Fractions of Accelerated Hypofractionated Post-operative Radiation Therapy in Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Why stopped (as posted): concern of extreme hypofractionation, toxicity. It is decided to go in a stepwise manner and first check feasibility of moderate hypofractionation like 50 Gy in 20 fractions or 45 Gy in 15 fractions.
Summary
Brief summary (as posted)
The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers. The present study is a non -randomized phase II study that will enroll 50 patients and test feasibility of 30 Gy in 5 fractions of the primary disease and ipsilateral level I-III disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Five fraction of post operative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Five fraction of post operative Radiotherapy
- description
- The present study is a non -randomised phase II study that will enroll 50 patients and test feasibility of 30 Gy in 5 fractions of the primary disease and ipsilateral level I-III disease.
- interventionNames
- Radiation: Five fraction of post operative radiotherapy
Primary outcomes (1)
- measure
- Severe late toxicity grade 3) at 2 year
- timeFrame
- 2 years
- description
- Severe late toxicity \> 3 or higher grade 3) at 2 year
Secondary outcomes (9)
- measure
- Loco-regional control rate
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 or above and less than 80 years. 2. Patient with high risk features: close (≤ 5mm) margin, presence of LVI or PNI, pT3-4. 3. Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature. 4. Pathological N0 neck requiring ipsilateral neck PORT. 5. Karnofsky performance score greater or equal 70. 6. Timely delivery of PORT preferable within 6-12 weeks of surgery (additional delay of 1-3 weeks of delay beyond 12 weeks is permissible to accommodate for delayed wound healing or other logistics). 7. Written informed consent for treatment. 8. Available to attend long term follow- up. Exclusion Criteria: 1. Pathologically positive neck disease. 2. Positive margin. 3. Patients requiring bilateral neck RT. 4. Patients that require re-irradiation for recurrent disease. 5. Previous radiotherapy to the head and neck region. 6. Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ). 7. Age \< 18 years or \> 80 years.
References
Publications (0)
Data not yet available