Phase II trial of stereotactic radiotherapy for patients with head and neck cancer

JRCT ID: jRCT1052240008

Registered date:10/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and neck cancer
• Date of first enrollment: 10/04/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Stereotactic ablative radiotherapy: 40 Gy in 10 fractions

Outcome(s)

• Primary Outcome: Time to loco-regional progression

Secondary Outcome

Response rate, non-hematological acute adverse event rate, late adverse event rate, loco-regional progression-free survival, progression-free survival, overall survival
Loco-regional control rate, loco-regional progression-free survival rate, progression-free survival rate, and overall survival rate at 6 months, 1 year, and 2 years
Change in QOL score
Proportion of patients with out-field local recurrence, proportion of patients with out-field regional lymph node recurrence

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with oropharyngeal, hypopharyngeal, laryngeal, oral, maxillary sinus, ethmoid sinus, nasal, or salivary gland cancer
2. Patients not applicable for surgery or radiotherapy for curative intent due to their general condition or social situation
3. Patients previously treated with radiotherapy to the head and neck region

• Exclude criteria: Patients with distant metastasis

Related Information

• Primary Sponsor: Nakashima Ryota