HYperfractionated Radiation Therapy Versus Concurrent Chemoradiation for Head and Neck Cancer (HYTC)

NCT07801235 | Recruiting

• 1 other identifier: 23 KHCC 141
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

This is an international multi-centre, non-inferiority phase III randomized controlled trial comparing concurrent chemoradiation with high dose cisplatin (Arm A) vs. hyperfractionated radiation therapy (Arm B) in patients with head and neck squamous cell carcinoma.

Conditions

Head and Neck (HNSCC)

Keywords

head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• OVERALL SURVIVAL

  To determine if hyperfractionated radiation therapy (Arm B) has a non-inferior overall survival (OS) compared to concurrent chemoradiation (CRT) with high dose cisplatin every 3 weeks (Arm A) in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC).

  7 YEARS

Secondary Outcomes (13)

• Oncologic outcomes

  7 YEARS

• Change in hearing threshold levels as assessed by pure tone audiometry

  7 YEARS

• Treatment-related toxicity/adverse events

  7 YEARS

• Change from baseline in Head and Neck Cancer-specific quality of life as assessed by the University of Washington Quality of Life Questionnaire

  7 YEARS

• Distant metastasis (DM) rate between treatment arms

  From randomisation till 7 years for each study participant

Study Arms (2)

concurrent Chemoradiation

ACTIVE COMPARATOR

concurrent chemoradiation with high dose cisplatin (Arm A) ) in patients with head and neck squamous cell carcinoma

Radiation: 70 gy 35 fractions/7weeks+high dose of cisplatin

hyperfractionated radiation therapy

EXPERIMENTAL

hyperfractionated radiation therapy 81.6 Gy

Radiation: 81.6 Gy /68 fractions BID FOR 7 WEEKS

Interventions

70 gy 35 fractions/7weeks+high dose of cisplatin RADIATION

70 Gy 35 fractions/7weeks+high dose of cisplatin

concurrent Chemoradiation

81.6 Gy /68 fractions BID FOR 7 WEEKS RADIATION

81.6 Gy /68 fractions BID FOR 7 WEEKS

hyperfractionated radiation therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic tonsillectomy or local excision of the primary without removal of nodal disease is permitted.
• Diagnostic lymph node excision or limited neck dissections (retrieving ≤ 4 nodes) are permitted HPV positive or negative (by p16 immunohistochemistry). OPC will be classified as p16 at local sites based on greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining.
• For patients with OPC: analysis of p16 status is required For patients with laryngeal/hypopharyngeal cancer: analysis of p16 status is NOT required
• Clinical stage T1-2 N1-2 M0 or T3 N0-2 M0 (UICC/AJCC TNM 8th Edition). Staging will be determined based on clinical examination, axial imaging (CT and/or MRI), and whenever available, PET-CT imaging.
• The following radiological investigations must be done within 8 weeks of registration:
• CT or MRI of the head and neck; PET-CT scan or chest CT scan (PET-CT scan is strongly preferred and highly recommended to be used for eligibility).
• Planned definitive RT. Based on clinical and laboratory evaluation and in keeping with local institutional standards, the treating oncologist must declare upfront, that in the absence of the present clinical trial, the patient would be candidate for treatment with concurrent high dose cisplatin every 3 weeks. This would include:
• Adequate hematologic function must be documented within 8 weeks prior to registration:
• Hemoglobin levels of \> 8g/dL (the use of transfusion or other intervention to achieve hemoglobin ≥ 8 g/dL is acceptable) Platelet count of \>100,000 cells/mm3. ANC of \> 1500 cells/mm3.
• Adequate hepatic function must be documented within 8 weeks prior to registration:
• Total bilirubin \< 2 X institutional upper limit of normal. AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal. Albumin ≥ 3.0 g/dL.
• Adequate renal function must be documented within 8 weeks prior to registration:
• Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula
• Patients known to be Human Immunodeficiency Virus (HIV)+ are permitted.
• Patients with CD4\>200 and serum HIV viral load of \< 200 copies/mm3 are eligible

You may not qualify if:

• HNC Patients with any of the following clinical stages/categories:
• cT1-2 N0 M0 cT4 cN3 cM1
• Patients with primary oral cavity cancer, nasopharynx cancer, or HNC of unknown primary.
• Previous HNC or multiple synchronous primary HNCs.
• Previous induction or neo-adjuvant chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded.
• Previous RT to the head and neck or neck dissection of at least 3 levels on either side.
• Patients with severe, active co-morbidity including any of the following:
• Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of registration Unstable angina and/or congestive heart failure requiring hospitalization within 6 months of registration Acute myocardial infarction within 6 months of study registration Diseases precluding RT (e.g. scleroderma) Persistent grade 3-4 (CTCAE v5) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing Active infection requiring IV antibiotics prior to registration; Chronic renal disease e.g., nephrotic syndrome, that could be worsened by cisplatin therapy History of allogenic organ transplantation Any symptomatic peripheral sensory neuropathy grade ≥ 2 (CTCAE v5)
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
• Prior allergic reaction to cisplatin

Sponsors & Collaborators

• King Hussein Cancer Center: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Issa Mohamad, Radiation oncologist

CONTACT

0799825592; imohamad@KHCC.JO

Ali Hosni, Radiation Onclogsit

CONTACT

+16478951225; ali.hosni@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: September 3, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2033
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

JO (1)