Head and Neck CancerAccelerateNCT05648461
Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer
A study testing Five fraction of post operative radiotherapy in people with Head and Neck Cancer, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Five fraction of post operative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- Pathologically positive neck disease.
- Positive margin.
- Patients requiring bilateral neck RT.
- Patients that require re-irradiation for recurrent disease.
- 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).
- Age < 18 years or > 80 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accelerate Trial: Phase II Study Exploring Five Fractions of Accelerated Hypofractionated Post-operative Radiation Therapy in Head and Neck Cancer
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.
Read the detailed description
Radiotherapy (RT) is an integral cancer treatment and RT utilization rates for commonly occurring carcinoma include breast: 87%, cervical: 71%, head and neck: 84%, lung: 77%, and prostate: 58% [1]. Overall, 57.5% of global head and neck cancers occur in Asia especially in India [2]. Head and neck cancers in India accounted for 30% of all cancers. In India, 60 to 80% of patients present with advanced disease as compared to 40% in developed countries [3]. Inequitable radiotherapy availability in India leads to non-compliance in many cases, as patients need to travel long distances for treatment. The number of functional radiotherapy units in India is below the limit recommended by the World Health Organization [3]. This poses a serious barrier to radiotherapy access as well as timely delivery of multidisciplinary cancer care.
Post operative radiation treatment for head and neck patients requires 6 weeks of time and the patient has to travel to the radiotherapy department daily for 5 days a week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. The Accelerate trial has potential to provide a quick solution (by reducing 30 fractions of PORT to 5 fractions) and is particularly suitable for resource constraint and overburdened radiotherapy. Five fractions of radiotherapy has been proven to be equally efficacious to long courses at various cancer sites like rectal cancer, breast cancer [4,5]. With small volume disease and technological advances in delivery of radiotherapy it is possible to deliver 5 fractions of hypofractionated RT to prostate, lung and pancreatic cancer [6-8].
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.
References
- Atun R, Jaffray DA, Barton MB, et al: Expanding global access to radiotherapy. Lancet Oncol 16:1153-1186, 2015.
- Chaturvedi P. Head and neck surgery. J Can Res Ther 2009; 5:143
- Kulkarni MR. Head and neck cancer burden in India. Int J Head Neck Surg. 2013; 4(1): 29- 35.
- van der Valk MJM, Marijnen CAM, van Etten B, et al; Collaborative investigators. Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer: results of the international randomized RAPIDO-trial. Radiother Oncol. 2020;147:75-83.
- Brunt AM , Haviland JS, Wheatley DA et al. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial Lancet, 395 (2020), pp. 1613-1626,
- Bezjak A, Paulus R, Gaspar LE, et al. Safety and efficacy of a five-fraction stereotactic body radiotherapy schedule for centrally located non-small-cell lung cancer: NRG oncology/RTOG 0813 trial. J Clin Oncol. 2019;37:1316-1325.
- Alongi F, Cozzi L, Arcangeli S, et al. Linac based SBRT for prostate cancer in 5 fractions with VMAT and flattening filter free beams: preliminary report of a phase II study. Radiat Oncol. 2013;8:171.
- Tchelebi LT, Lehrer EJ, Trifiletti DM, Sharma NK, Gusani NJ, Crane CH, Zaorsky NG. Conventionally fractionated radiation therapy versus stereotactic body radiation therapy for locally ad-vanced pancreatic cancer (CRiSP): an international systematic review and meta-analysis. Cancer. 2020;126:2120-2131
- Conditions
- Head and Neck Cancer
- Being tested
- Five fraction of post operative radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five fraction of post operative radiotherapyRadiation
Target volume will include tumor bed \& ipsilateral level I-III levels.
| Study group | Role | What they receive |
|---|---|---|
| Five fraction of post operative Radiotherapy | Experimental | 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. Receives: Radiation: Five fraction of post operative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe late toxicity grade 3) at 2 year
Severe late toxicity > 3 or higher grade 3) at 2 year
Measured: 2 years
Secondary outcomes (9)
Loco-regional control rate
Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months
Measured: 2 years
Disease free survival
Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months]
Measured: 2 years
Overall Survival
Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months]
Measured: 2 years
Regional recurrence at ipsilateral level IV
Time to an event [longitudinal assessment at 3, 6, 12, 18, 21 and 24 months]
Measured: 2 years
Acute toxicity
RTOG scale
Measured: Every week for first month
Late toxicity
RTOG scale [longitudinal assessment at 3, 6, 12, 18 and 24 months]
Measured: 2 years
Swallowing function
MD Anderson Dysphagia Inventory [longitudinal assessment at 3, 6, 12, 18 and 24 months]
Measured: 2 years
Quality of life EORTC QLQC30
EORTC QLQC30 module [longitudinal assessment at 3, 6, 12, 18 and 24 months] The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: 2 years
Quality of life H&B35
EORTC H\&B35 module [longitudinal assessment at 3, 6, 12, 18 and 24 months]
The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H\&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Mar 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aman Sharma, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648461
- Sponsor's protocol ID
- The Accelerate Trial
- Acronym
- Accelerate
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accelerate Trial: Phase II Study Exploring Five Fractions of Accelerated Hypofractionated Post-operative Radiation Therapy in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05648461
- Acronym / sponsor ID
- Accelerate / The Accelerate Trial
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radiotherapy (RT) is an integral cancer treatment and RT utilization rates for commonly occurring carcinoma include breast: 87%, cervical: 71%, head and neck: 84%, lung: 77%, and prostate: 58% [1]. Overall, 57.5% of global head and neck cancers occur in Asia especially in India [2]. Head and neck cancers in India accounted for 30% of all cancers. In India, 60 to 80% of patients present with advanced disease as compared to 40% in developed countries [3]. Inequitable radiotherapy availability in India leads to non-compliance in many cases, as patients need to travel long distances for treatment. The number of functional radiotherapy units in India is below the limit recommended by the World Health Organization [3]. This poses a serious barrier to radiotherapy access as well as timely delivery of multidisciplinary cancer care.
Post operative radiation treatment for head and neck patients requires 6 weeks of time and the patient has to travel to the radiotherapy department daily for 5 days a week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. The Accelerate trial has potential to provide a quick solution (by reducing 30 fractions of PORT to 5 fractions) and is particularly suitable for resource constraint and overburdened radiotherapy. Five fractions of radiotherapy has been proven to be equally efficacious to long courses at various cancer sites like rectal cancer, breast cancer [4,5]. With small volume disease and technological advances in delivery of radiotherapy it is possible to deliver 5 fractions of hypofractionated RT to prostate, lung and pancreatic cancer [6-8].
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.
References
- Atun R, Jaffray DA, Barton MB, et al: Expanding global access to radiotherapy. Lancet Oncol 16:1153-1186, 2015.
- Chaturvedi P. Head and neck surgery. J Can Res Ther 2009; 5:143
- Kulkarni MR. Head and neck cancer burden in India. Int J Head Neck Surg. 2013; 4(1): 29- 35.
- van der Valk MJM, Marijnen CAM, van Etten B, et al; Collaborative investigators. Compliance and tolerability of short-course radiotherapy followed by preoperative chemotherapy and surgery for high-risk rectal cancer: results of the international randomized RAPIDO-trial. Radiother Oncol. 2020;147:75-83.
- Brunt AM , Haviland JS, Wheatley DA et al. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial Lancet, 395 (2020), pp. 1613-1626,
- Bezjak A, Paulus R, Gaspar LE, et al. Safety and efficacy of a five-fraction stereotactic body radiotherapy schedule for centrally located non-small-cell lung cancer: NRG oncology/RTOG 0813 trial. J Clin Oncol. 2019;37:1316-1325.
- Alongi F, Cozzi L, Arcangeli S, et al. Linac based SBRT for prostate cancer in 5 fractions with VMAT and flattening filter free beams: preliminary report of a phase II study. Radiat Oncol. 2013;8:171.
- Tchelebi LT, Lehrer EJ, Trifiletti DM, Sharma NK, Gusani NJ, Crane CH, Zaorsky NG. Conventionally fractionated radiation therapy versus stereotactic body radiation therapy for locally ad-vanced pancreatic cancer (CRiSP): an international systematic review and meta-analysis. Cancer. 2020;126:2120-2131
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Five fraction of post operative Radiotherapy | Experimental | Radiation: Five fraction of post operative radiotherapyThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- Pathologically positive neck disease.
- Positive margin.
- Patients requiring bilateral neck RT.
- Patients that require re-irradiation for recurrent disease.
- Previous radiotherapy to the head and neck region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five fraction of post operative radiotherapyTarget volume will include tumor bed \& ipsilateral level I-III levels. | Radiation | Five fraction of post operative Radiotherapy |
Primary outcome
Severe late toxicity grade 3) at 2 year
Time frame: 2 years
Severe late toxicity > 3 or higher grade 3) at 2 year
9 secondary outcomes
Loco-regional control rate
Time frame: 2 years
Disease free survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Regional recurrence at ipsilateral level IV
Time frame: 2 years
Acute toxicity
Time frame: Every week for first month
Late toxicity
Time frame: 2 years
Swallowing function
Time frame: 2 years
Quality of life EORTC QLQC30
Time frame: 2 years
Quality of life H&B35
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Five fraction of post operative radiotherapy in people with Head and Neck Cancer, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe late toxicity grade 3) at 2 year (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.