Clinical Trial: A Multicenter Prospective Study to Evaluate the Efficacy and Safety of Weekly 8 Gy x 3 Palliative Radiotherapy for Symptomatic Head and Neck Cancer (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062684) titled 'A Multicenter Prospective Study to Evaluate the Efficacy and Safety of Weekly 8 Gy x 3 Palliative Radiotherapy for Symptomatic Head and Neck Cancer' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - Head and Neck Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to prospectively evaluate the objective response to Weekly 8 (8 Gy once weekly for three fractions) in patients undergoing palliative radiotherapy for symptomatic head and neck cancer, and to assess its safety, symptom palliation, quality-of-life benefits, and treatment feasibility. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Weekly 8 (8 Gy once weekly for three fractions)

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. The treating physician has determined prior to enrollment that the patient is not a candidate for local treatment with curative intent. 2. The patient has symptoms in the head and neck region caused by head and neck cancer. 3. The patient is aged 18 years or older at enrollment. 4. Written informed consent has been obtained from the patient. 5. The patient has an ECOG performance status of 0-3. 6. The patient has a pathological diagnosis of head and neck cancer. 7. The target lesion is adequately visualized on CT or MRI. 8. If the patient is receiving systemic therapy, the most recent systemic therapy must have been completed before the date of baseline imaging, and no systemic therapy may be administered within 7 days before the start of radiotherapy. Key exclusion criteria - 1. The patient is unable to maintain the supine position. 2. The patient has a history of radiotherapy overlapping the study treatment target lesion or the planned irradiation field. 3. The target lesion is a bone metastasis. 4. The patient is scheduled to initiate or resume systemic therapy after the baseline imaging assessment and before the 2-month imaging assessment, which is the primary endpoint assessment. 5. The patient is pregnant or may be pregnant. 6. The principal investigator or a subinvestigator considers the patient unsuitable for participation in the study. Target Size - 95

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 18 Day Anticipated trial start date - 2027 Year 01 Month 01 Day Last follow-up date - 2031 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071771

Disclaimer: Curated by HT Syndication.