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WithdrawnNo phase
Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer
Key facts
- Who runs it
- All India Institute of Medical Sciences
- Where
- India1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 1 Mar 2023
- Ended
- 1 Feb 2026
- Type of study
- Interventional
- Treatments tested
- Five fraction of post operative radiotherapy
- Record updated
- 11 September 2026
- Why it stopped
- 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.
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Aged 18 or above and less than 80 years
- Patient with high risk features: close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
- Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature
- Pathological N0 neck requiring ipsilateral neck PORT
- Karnofsky performance score greater or equal 70
- 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)
- Written informed consent for treatment
- Available to attend long term follow- up
Who cannot take part
- Previous radiotherapy to the head and neck region
- Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ)
- Pathologically positive neck disease
- Patients that require re-irradiation for recurrent disease
- Age < 18 years or > 80 years
- Positive margin
- Patients requiring bilateral neck RT
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Five fraction of post operative RadiotherapyTreatment being tested
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Accelerate Trial: Phase II Study Exploring Five Fractions of Accelerated Hypofractionated Post-operative Radiation Therapy in Head and Neck Cancer
- Record updated
- 11 September 2026