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

A phase I clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes using carbon-ion beams and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix - Cervix-V (Protocol 1207)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008349

Enrollment

Registered

2012-08-01

Start date

2012-08-01

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

Uterine cervical cancer

Interventions

5 weeks Carbon ion radiotherapy: 72.0 GyE / 20 fractions Chemotherapy: weekly cisplatin 30-40 mg / m2 for 5 weeks.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Squamous cell carcinoma of the uterine cervix 2. International Federation of Gynecology and Obstetrics (FIGO) Stage IIB(>= 4 cm in diameter), III, or IVA disease 3. No para-aortic lymph nodes >= 1 cm in minimum diameter on CT images 4. The tumor had to be grossly measurable. 5. Age between 20 and 70 years 6. Performance status 0 - 2 7. Patients with no histories of prior chemotherapy or pelvic radiotherapy for cervical cancer 8. Normal organ function (WBC >= 3000/mm3,Hb >= 10g/dl, Plt>= 100,000/mm3, T-Bil.<= 1.5mg/dl, AST(GOT) and ALT(GPT) <= 100IU/dl, Cre <= 1.5mg/dl, CCR >= 50ml/min, ECG normal or require no treatment 9. Estimated life expectancy of _6 months 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe complicating illness 2. Active double cancer 3. Rectal invasion 4. History of pelvic radiotherapy 5. History of prior chemotherapy 6. medical, psychological or others reason that primary doctor think ineligible

Design outcomes

Primary

Measure	Time frame
Acute toxicity of organ at risks	—

Secondary

Measure	Time frame
Primary response rate by recommended dose in 6 months after treatment	—

Countries

Japan

Contacts

Public ContactMasaru Wakatsuki

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

waka@nirs.go.jp043-206-3306

Outcome results

None listed

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