Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-02-01 @ 11:06 PM
Study NCT ID:
NCT05648461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer
Sponsor:
All India Institute of Medical Sciences
Organization:
Study Overview
Official Title:
The Accelerate Trial: Phase II Study Exploring Five Fractions of Accelerated Hypofractionated Post-operative Radiation Therapy in Head and Neck Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Accelerate
Brief 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.
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
1. Atun R, Jaffray DA, Barton MB, et al: Expanding global access to radiotherapy. Lancet Oncol 16:1153-1186, 2015.
2. Chaturvedi P. Head and neck surgery. J Can Res Ther 2009; 5:143
3. Kulkarni MR. Head and neck cancer burden in India. Int J Head Neck Surg. 2013; 4(1): 29- 35.
4. 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.
5. 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,
6. 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.
7. 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.
8. 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
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
1. Atun R, Jaffray DA, Barton MB, et al: Expanding global access to radiotherapy. Lancet Oncol 16:1153-1186, 2015.
2. Chaturvedi P. Head and neck surgery. J Can Res Ther 2009; 5:143
3. Kulkarni MR. Head and neck cancer burden in India. Int J Head Neck Surg. 2013; 4(1): 29- 35.
4. 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.
5. 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,
6. 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.
7. 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.
8. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: