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A phase II study of hypofractionated radiotherapy for esophageal cancer

A phase II study of hypofractionated radiotherapy for esophageal cancer - A phase II study of hypofractionated radiotherapy for esophageal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054660
Enrollment
40
Registered
2024-07-12
Start date
2024-08-01
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

esophageal cancer

Interventions

radiotherapy

Sponsors

Tohoku University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. histologically proven esophageal cancer 2. Cases with T1-4a, N0-3, M0/1 lym (Japanese Esophageal Cancer Guidelines, 12th Edition) 3. Age 20 years or older and younger than 90 years old (at time of registration) 4. Performance Status (ECOG):0-1 5. Cases where surgery is inoperable or refusal is made 6. Cases where concurrent chemotherapy is difficult or refusal is made 7. Written consent has been obtained from the individual to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1. Patients with distant organ metastases other than supraclavicular or longitudinal lymph nodes. 2. Patients with a history of radiation therapy near the lesion (cases where the radiation field overlaps with this treatment). 3. Patients after esophageal cancer EMR or ESD. 4. Patients with an esophageal stent placed in the esophagus. 5. Cases with active simultaneous cancers requiring treatment other than superficial gastric cancer, prostate cancer, hypopharyngeal cancer, and primary lung cancer with only ground-glass opacity. Or cases with a disease-free period of less than 3 years, even if metachronous. 6. Patients with severe complications such as poorly controlled diabetes, collagen disease, interstitial pneumonia, and psychiatric disorders, who are not expected to tolerate this study protocol. 7. Patients with proven active infections and a fever of 38 degree or higher. 8. Patients who regularly use steroids. 9. Patients with other complications that are deemed to seriously impede the administration of treatment.

Design outcomes

Primary

MeasureTime frame
Incidence of dysphagia 6 months after starting treatment

Secondary

MeasureTime frame
Frequency and severity of adverse events, patient QOL and response rate

Countries

Japan

Contacts

Public ContactKeiichi Jingu

Tohoku University Graduate School of Medicine Department of Radiation Oncology

kjingurad@yahoo.co.jp022-717-7312

Outcome results

None listed

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