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Neoadjuvant irinotecan and nedaplatin followed by radical hysterectomy for bulky stage Ib/II cervical cancer

Neoadjuvant irinotecan and nedaplatin followed by radical hysterectomy for bulky stage Ib/II cervical cancer - KCOG-G1201 study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021727
Enrollment
68
Registered
2016-04-07
Start date
2012-05-29
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-IIb of uterine cervical cancer

Interventions

neoadjuvant chemotherapy

Sponsors

Kansai Clinical Oncology Group; KCOG
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) pathologically diagnosed with squamous cell carcinoma in uterine of the cervix 2) stageIB2-IIb with bulky tumor (more than 4cm) 3) no previous therapy 4) ECOG performance status 0-1 5) Neutrocyte > 2,000/mm3 Platelet > 100,000/mm2 Hemoglobin > 9.0 g/dL AST, ALT < 100IU/L Total bilirubin < 1.5mg/dL Serum creatinine < 1.5mg/dL Creatinine clearance >60ml/min 6) obtained informed consent

Exclusion criteria

Exclusion criteria: 1) remarkable infection 2) severe complications (heart disease, incontorable diabetes) 3) with other malignancies 4) interstitial pneumonia 5) massive ascites 6) severe diarrhea 7) ileus 8) pregnant women 9) past history of severe allergy for drug

Design outcomes

Primary

MeasureTime frame
2 year overall survival rate—

Secondary

MeasureTime frame
reponse rate of the neoadjuvant chemotherapy, adverse events rate—

Countries

Japan

Contacts

Public ContactTaisuke Mori

Kyoto Prefectural University of Medicine Department of Obstetrics and Gynecology

moriman@koto.kpu-m.ac.jp075-251-5560

Outcome results

None listed

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