A phase I/II clinical trial of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix

A phase I/II clinical trial of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix - Carbon-ion radiotherapy and concurrent chemotherapy for locally advanced adenocarcinoma of the uterine cervix

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003585

Enrollment

Registered

2010-05-10

Start date

2010-04-01

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

locally advanced adenocarcinoma of the uterine cervix

Interventions

A total dose of 68.0-74.4 GyE in 20 fractions of carbon-ion radiotherapy is administered for 5 weeks. Cisplatin 40mg/m2 is administered weekly for 5 weeks concurrently with carbon-ion radiotherapy.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pathologically proven adenocarcinoma or adenosquamous carcinoma of the uterine cervix 2. Stage IIB, III, or IVA disease (FIGO 1994) 3. No enlarged para-aortic lymph node by CT scan 4. Measurable disease 5. Age; 20-70 years 6. PS; WHO 0-2 7. Patients with unresectable disease or patients who refuse surgery 8. No prior surgery or chemotherapy to cervical cancer 9. Adequate bone marrow, hepatic, and renal functions; white blood cells >= 3000/m3 hemoglobin >= 10g/dl platelets >= 100,000/m3 total bilirubin <= 1.5mg/dl AST/ALT <= 100IU/dl serum creatinine <= 1.5mg/dl creatinine clearance >= 50ml/min ECG: within normal range 10. Life expectancy; longer than 6 months 11. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe concomitant illness (e.g. uncontrolled heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infectious disease, active gastric ulcer, uncontrolled mental illness) 2. History of other malignancies within the past 5 years 3. Tumor invading directly to the rectum 4. Prior radiotherapy to the pelvis 5. Patients who are judged inappropriate for the entry into the study by the investigator

Design outcomes

Primary

Measure	Time frame
Phase I study Acute toxicity (to determine the maximum tolerated dose and the recommended dose for phase II study) Phase II study Response rate	—

Secondary

Measure	Time frame
Phase I study Response rate at the RD level Phase II study Acute and late toxicity Local control Progression-free survival Overall survival	—

Countries

Japan

Outcome results

None listed

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