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Clinical study on efficacy and safety of carbon ion radiotherapy combined with image-guided brachytherapy for locally advanced uterine cervical cancer

Clinical study on efficacy and safety of carbon ion radiotherapy combined with image-guided brachytherapy for locally advanced uterine cervical cancer - Carbon ion radiotherapy combined with image-guided brachytherapy for locally advanced uterine cervical cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015015
Enrollment
60
Registered
2014-09-01
Start date
2014-08-01
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

Locally advanced uterine cervical cancer

Interventions

Carbon ion radiotherapy Image-guided brachytherapy Chemotherapy (Cisplatin)

Sponsors

Gunma University Heavy Ion Medical Research Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed adenocarcinoma, adeno-squamous cell carcinoma, or squamous cell carcinoma of uterine cervix. 2) FIGO Stage II (larger than or equal to 4 cm), III, or IV. 3) No para-aortic lymph node with the smaller diameter equal to or larger than 1 cm is observed in CT within 4 weeks before registration. 4) Measurable tumors on CT or MRI. 5) Age >=20 <=75. 6) Performance status 0-2. 7) No prior history of surgery or chemotherapy for uterine cervical cancer. 8) No abnormality in major organ functions. 9) Expected life expectancy of more than 6 months. 10) Informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1) Tumor invasion to gastro-intestinal tract. 2) Past history of chemotherapy. 3) Past history of radiotherapy in pelvis. 4) Uncontrolled infection in pelvis. 5) Severe concomitant diseases. 6) Active concurrent cancers. 7) (Possibly) pregnant patients. 8) Other medically or psychologically unsuitable circumstances are present.

Design outcomes

Primary

MeasureTime frame
progression-free rate in the pelvis

Secondary

MeasureTime frame
1) Local control rate 2) Progression-free survival rate 3) Incidence rate of acute adverse effects 4) Incidence rate of late adverse effect

Countries

Japan

Contacts

Public ContactTatsuya Ohno

Gunma University Gunma University Heavy Ion Medical Center

tohno@gunma-u.ac.jp027-220-8378

Outcome results

None listed

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