Phase III study of Z-100 in uterine cervix cancer patients

Phase III study of Z-100 in uterine cervix cancer patients - Phase III study of Z-100 in uterine cervix cancer patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000221

Enrollment

240

Registered

2005-09-13

Start date

2004-09-01

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

primary uterine cervix cancer

Interventions

Z group : During radiotherapy period, Z-100 subcutaneous administration into upper arm (1 ampul, 2 times/week, 3-4 day interval, start within 3 days after radiotherapy). Only response case, after judg

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)FIGO stage II-IVa 2)Histologically proven epidermoid carcinoma 3)No prior treatment for uterine cervix cancer 4)No abdominal paraaortic lymph node metastases 5)Being able to have intravaginal radiation therapy 6)Performance Status(PS) 0,1,2 7)Sufficient organ function (bone marrow, liver, kidney) 8)Written Informed Consent

Exclusion criteria

Exclusion criteria: 1)Synchronous and metachronous carcinomas within 5 years 2)Serious renal disease except hydronephrosis because of uterine cervix cancer 3)Past history of allergy to cisplatin or other platinum drug (patient planning concomitant use of cisplatin) 4)Past history of serious drug allergy 5)Pregnancy or lactation 6)Patients judged inappropriate for this study by phisicians

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
Cancer Death-Free Survival Relapse-Free Survival Effect of tumor size reduction Adverse Drug Reaction, Adverse Events	—

Countries

Japan

Outcome results

None listed

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