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A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy

A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy - A phase I clinical trial of stereotactic body radiotherapy for patients with cervical cancer unsuitable for intracavitary brachytherapy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020519
Enrollment
12
Registered
2016-01-11
Start date
2016-01-01
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

Cervical cancer

Interventions

Whole pelvic irradiation using IMRT: 45 Gy/25 fr. SBRT for primary lesion: 19.5 - 22.5 Gy/3 fr.

Sponsors

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. pathological diagnosis of primary cervical cancer 2. FIGO stage; Ib1-IIIB 3. N stage 0-1, Clinical stage Ib1-IIIb 4. Unsuitable for intracavitary brachytherapy 5. Age; 20- 6. ECOG PS; 0-2 7. No previous radiotherapy in the pelvic organs 8. Written informed consent 9. Adequate organ function

Exclusion criteria

Exclusion criteria: 1. Serious medical or psychological problems 2. Other active cancer 3. Be pregnant or just after giving birth

Design outcomes

Primary

MeasureTime frame
Decision of the recommended dose by adverse effects in 6 months after the treatment

Secondary

MeasureTime frame
Response rate in the arm of recommend dose Local control Adverse events

Countries

Japan

Contacts

Public ContactKei Ito

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Radiation Oncology

keiito@cick.jp03-3823-2101

Outcome results

None listed

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