NCT05120947|CompletedResultsDMCFDA Device
Hypofractionated Adjuvant Radiotherapy for Resected Head and Neck Cancers
HART-HN
A Phase I Study of Hypofractionated Adjuvant Radiotherapy for Resected Head and Neck Cancers (HART-HN)
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HART-HN
A Phase I Study of Hypofractionated Adjuvant Radiotherapy for Resected Head and Neck Cancers (HART-HN)
Sponsor study identifier
interventional
18
1 country
1
Study Start
December 1, 2021
Actual (reported)Primary Completion
March 6, 2025
Actual (reported)Study Completion
November 22, 2025
Actual (reported)The primary purpose of this study is to determine the safe reduction of the treatment fractions to 10, 8, or 5, that may be delivered safely in resected head and neck squamous cell carcinoma (HNSCC) patients with intermediate pathologic risk features.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 3, 2021
Actual (reported)November 16, 2021
Actual (reported)December 1, 2021
Actual (reported)March 6, 2025
Actual (reported)November 22, 2025
Actual (reported)March 17, 2026
Actual (reported)Maximum-tolerated Radiation Dose
This will be determined as the radiation dose with the minimum number of fractions at which there is no more than a 33% rate of dose-limiting toxicity (DLT) up to 12 months after completion of radiation treatment using the TITE-CRM design.
12 months
Incidence of Dose-Limiting Toxicities
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
12 months
Overall Survival
One year
Locoregional Progression
One year
42 gy of radiation therapy will be administered in 10 fractions.
39 gy of radiation therapy will be administered in 8 fractions.
32.5 gy of radiation therapy will be administered in 5 fractions.
Radiation Therapy: Dose per fraction of 4.2 Gy.
Radiation Therapy: Dose per fraction of 4.875 Gy.
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Moran MS, Truong PT. Hypofractionated radiation treatment for breast cancer: The time is now. Breast J. 2020 Jan;26(1):47-54. doi: 10.1111/tbj.13724. Epub 2020 Jan 15.
Benjamin LC, Tree AC, Dearnaley DP. The Role of Hypofractionated Radiotherapy in Prostate Cancer. Curr Oncol Rep. 2017 Apr;19(4):30. doi: 10.1007/s11912-017-0584-7.
Stevens G, Thompson JF, Firth I, O'Brien CJ, McCarthy WH, Quinn MJ. Locally advanced melanoma: results of postoperative hypofractionated radiation therapy. Cancer. 2000 Jan 1;88(1):88-94. doi: 10.1002/(sici)1097-0142(20000101)88:13.0.co;2-k.
Musaddiq Awan, MD
Medical College of Wisconsin
18 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2021
First Posted
November 16, 2021
Study Start
December 1, 2021
Radiation Therapy: Dose per fraction of 6.5 Gy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Tupchong L, Scott CB, Blitzer PH, Marcial VA, Lowry LD, Jacobs JR, Stetz J, Davis LW, Snow JB, Chandler R, et al. Randomized study of preoperative versus postoperative radiation therapy in advanced head and neck carcinoma: long-term follow-up of RTOG study 73-03. Int J Radiat Oncol Biol Phys. 1991 Jan;20(1):21-8. doi: 10.1016/0360-3016(91)90133-o.
Kumar AMS, Miller J, Hoffer SA, Mansur DB, Coffey M, Lo SS, Sloan AE, Machtay M. Postoperative hypofractionated stereotactic brain radiation (HSRT) for resected brain metastases: improved local control with higher BED10. J Neurooncol. 2018 Sep;139(2):449-454. doi: 10.1007/s11060-018-2885-6. Epub 2018 May 10.
Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. 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. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28.
Primary Completion
March 6, 2025
Actual (reported)Study Completion
November 22, 2025
Actual (reported)Last Updated
May 1, 2026
Results First Posted
March 17, 2026
Record last verified: 2026-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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