Phase I study of combination chemotherapy with irinotecan hydrochroride(CPT-11) and nedaplatin(NDP) for locally advanced stage Ib2-IVa cervical cancer after Concurrent chemoradiotherapy (CCRT)

Phase I study of combination chemotherapy with irinotecan hydrochroride(CPT-11) and nedaplatin(NDP) for locally advanced stage Ib2-IVa cervical cancer after Concurrent chemoradiotherapy (CCRT) - Phase I study of combination chemotherapy with CPT-11 and NDP for cervical cancer after CCRT

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007458

Enrollment

Registered

2012-03-06

Start date

2012-04-01

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

Stage Ib2-IVa cervical cancer

Interventions

Irinotecan dose escalation day 1,8+Nedaplatin dose escalation day 1,q 4 weeks 4 cycles. Treatment cycles are repeated every 28 days until disease progression, unless the dose level is considered as th

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Pathologicaly confirmed cervical cancer (squamous cell carcinoma) 2) FIGO Stage lb2-lVa 3) Completely have Concurrent chemoradiotherapy(CCRT) 4) No prior therapy other than Concurrent chemoradiotherapy(CCRT) 5) 20 years-old<=age<=70 years-old 6) ECOG performance status of 0 to 1 7) Adequate bone marrow, cardiac, pulmonry functions. 8) Patients homozygous for UGT1A1*1, or heterozygous for UGT1A1*28 or UGT1A1*6 9) Written informed consent 10)Able to have a chemothrapy within 4-8 weeks after Concurrent chemoradiotherapy(CCRT)

Exclusion criteria

Exclusion criteria: 1) Patients with serious complications 2) Patients with active infections 3) Patients with active concomitant malignancy 4) Patients underwent exploratory laparotomy 5) Patients with interstitial pneumonia or pulmonary fibrosis 6) Patients with massive pleural, cardiac effusion, and/or ascites 7) Patients with coneraindication to CPT-11or NDP 8) Patients with diarrhea (watery stool) 9) Patients with any history of serious drug reactions or hypersensitivity 10) Patients with HBs antigen 11) Patients treated with radiation therapy of the paraaortic lymph nodes in cervical carcinoma 12) Patients with progression of cervical carcinoma disease during concurrent chemoradiotherapy(CCRT) 13)Patients are inappropriate to enter this study with any safety reasons, judged by the treating physician

Design outcomes

Primary

Measure	Time frame
Recommended Dose(RD)	—

Secondary

Measure	Time frame
1)Incidence of morbidity 2)Completeness	—

Countries

Japan

Contacts

Public ContactHisaya Fujiwara, M.D.,Ph.D.

Chugoku Rousai Hospital Department of Obstetrics and Gynecology

hisafuji@chugokuh.rofuku.go.jp0823-72-7171

Outcome results

None listed

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