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Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2)

Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2) - Multicenter prospective observational study on the effectiveness of hypofractionated palliative radiotherapy for advanced head and neck squamous cell carcinoma (JROSG 18-2)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000039971
Enrollment
50
Registered
2020-03-29
Start date
2020-05-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced head and neck squamous cell carcinoma

Interventions

None listed

Sponsors

Japanese Radiation Oncology Study Group (JROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients scheduled for 3D-CRT or IMRT palliative fractionated radiotherapy (QUAD Shot; 14-14.8 Gy/4 fractions/2 days/cycle; 3-6 weeks interval; totally 3 cycles) for advanced head and neck squamous cell carcinoma (Stage III or IV on UICC 8th). 2) Patients who are not indicated for radical radiotherapy (conventionally fractionated irradiation with 60Gy or more). For example, patients who have refused radical radiotherapy or in whom radical radiotherapy is not feasible due to advanced lesions, old age, or complications. Patients who cannot tolerate conventionally fractionated irradiation under long-term hospitalization management due to complications such as delirium are also included in the criteria. 3) Patients aged 20 and older. 4) Patients pathologically diagnosed with squamous carcinoma of the head and neck region with lesions that can be assessed on imaging modalities. 5) Patients with ECOG performance status (PS) 0 to 3. 6) Patients who are fully informed prior to participating in this study, and voluntarily provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with previous radiotherapy on regions that overlap with the irradiated volume. 2) Women who are pregnant, breastfeeding or may be pregnant. 3) Patients whom the attending physician deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Completion rate for three cycles.

Secondary

MeasureTime frame
Tumor response assessment based on imaging findings and physical examinations, overall survival, progression-free survival, QOL score, adverse events, additional treatment.

Countries

Japan

Contacts

Public ContactRyo Toya

Nagasaki University Radiological Sciences

toya@nagasaki-u.ac.jp+81958197354

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026