A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer

A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer - A phase ll study of adjuvant chemotherapy for node-positive cervical cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003036

Enrollment

Registered

2010-01-14

Start date

2010-01-01

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 lb2 lla cervical cancer with pelvic lymph node metastasis

Interventions

Irinotecan 60mg/m2 day1,8+Nedaplatin 80mg/m2 day q4weeks 5cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Pathologicaly confirmed cervical cancer(squamous cell carcinoma) 2)FIGO Stagelb2 or lla,including pathological parametrium involvement 3)Completely have radical hysterectomy and pelvic lymph node metastasis 4)Tumor removed completely by surgery 5)No prior therapy 6)20years-old<=age<=70years-old 7)ECOG performance status of 0 to 1 8)Adequate bone marrow,cardiac,pulmonry functions 9)Patients homozygous for UGT1A1*1,or heterozygous for UGT1A1*28 or UGT1A1*6 10)Written informed consent 11)Able to have a chemothrapy within 6 weeks after surgery

Exclusion criteria

Exclusion criteria: 1)Patients with paraaortic lymph node metastasis 2)Patients with positive histological margin 3)Patients with adnexal involvement 4)Patients with tumor extension to other organs 5) Patients with active infections 6) Patients with serious complications 7) Patients with active concomitant malignancy 8) Patients with interstitial pneumonia or pulmonary fibrosis 9) Patients with massive pleural, cardiac effusion, and/or ascites 10) Patients with coneraindication to CPT-11or NDP 11) Patients with diarrhea (watery stool) 12) Patients with intestinal paralysis or illeus 13) Patients with any history of serious drug reactions or hypersensitivity 14) Patients with HBs antigen 15)Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

Design outcomes

Primary

Measure	Time frame
Two-year relapse-free survival rate	—

Secondary

Measure	Time frame
Incidence of morbidity Completeness of chemothrapy Overall survival in 5 years Relapse-free survival in 5 years Incidence of leg lymphedema	—

Countries

Japan

Contacts

Public ContactNobuhiro Takeshima, M.D.

JGOG1067 Coordinating Office CANCER INSTITUTE HOSPITAL

jgog1067@jgog.gr.jp03-3520-0111

Outcome results

None listed

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