A phase I/II clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes in locally advanced squamous cell carcinoma of the uterine cervix using carbon-ion beams

A phase I/II clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes in locally advanced squamous cell carcinoma of the uterine cervix using carbon-ion beams - Cervix IV

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016169

Enrollment

Registered

2015-01-09

Start date

2006-04-01

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

uterine cervical cancer

Interventions

Prophylactic extended-field (Pelvic and para-aorta lymph node regions) Carbon-ion radiotherapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pathologically proven squamous cell carcinoma of the uterine cervix 2. International Federation of Gynecology and Obstetrics (FIGO 1994) Stage IIB with tumor size > 4 cm in diameter, III, or IVA disease without rectal invasion 3. Patient does not have para-aortic lymph nodes > 1 cm in minimum diameter on CT image 4. Tumor must be grossly measurable 5. Age < 80 years 6. World Health Organization performance status < 3 7. Adequate bone marrow function; WBC > 3000 cells/mm3, Platelets > 100,000 cells/mm3, Hemoglobin > 10.0 g/dl 8. Estimated life expectancy > 6 months 9. Patient provides written informed consent to participate in this study before initiation of therapy.

Exclusion criteria

Exclusion criteria: 1. Severe co-morbidity; severe pelvic infection, severe psychological illness etc. 2. Active synchronous cancer 3. Prior radiotherapy to the pelvic or para-aortic region 4. Prior chemotherapy 5. Medical, psychological or other factor deciding ineligibility by attending physician

Design outcomes

Primary

Measure	Time frame
Acute toxicity	—

Countries

Japan

Contacts

Public ContactMasaru Wakatsuki

National Institute of Radiological Sciences Research Center Hospital for Charged Particle Therapy

wakkun100@yahoo.co.jp043-206-3306

Outcome results

None listed

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