Phase I/II study about nedaplatin plus radiation (external beam + intra-cavitary) for local advanced uterine cervical cancer.

Phase I/II study about nedaplatin plus radiation (external beam + intra-cavitary) for local advanced uterine cervical cancer. - Nedaplatin in cemoradiation for uterine cervical cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007218

Enrollment

Registered

2012-02-03

Start date

2010-10-01

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

Phase I = Nedaplatin 80mg/m2 --&gt

90mg/m2 --&gt

100mg/m2 Phase II = recommeded dose (RD)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histopathological proven uterine cervical carcinoma 2. cT1b-2a with bulky mass (tumor size > 4cm) or cT2b-4a 3. PS: 0-2 4. written informed consent 5. WBC: 4000-12000/mm3, Neu > 2000/mm3, Plt > 100,000/mm3 Hb > 9.0g/dL, Tbil < 1.5mg/dL, GOT/GPT < 76/72, CRE < 1.2

Exclusion criteria

Exclusion criteria: 1. chemotherapy naive 2. pelvic irradiation naive 3. M1 (having distant metastasis) 4. having para-aortic lymph node metastasis 5. having serious coexisting illness 6. having synchronism overlap cancer

Design outcomes

Primary

Measure	Time frame
In step 1, MTD (maximum tolerated dose) and RD(recommended dose) of nedaplatin.	—

Secondary

Measure	Time frame
In stap 2, primary endpoint = response rate and secondary endpoints = safety (occurrence frequency of adverse event), progress free survival, and overall survival.	—

Countries

Japan

Contacts

Public ContactKae Okuma

University of Tokyo Hospital Department of Radiology

ookumak-rad@h.u-tokyo.ac.jp03-5800-8743

Outcome results

None listed

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