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Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors

Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors - SGSG008/ TGCU Intergroup study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001539
Enrollment
90
Registered
2009-01-01
Start date
2008-04-01
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 Ib- II patients with uterine cervical nonsquamous cell carcinoma with risk factors, including pelvic lymphnode involvement and/ or parametrial extension

Interventions

Adjuvant chemotherapy for stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factor after radical hysterectomy

Sponsors

Sankai Gynecologic Study Group(SGSG), Tohoku Gynecologic Cancer Unit(TGCU)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factors after radical hysterectomy. Risk factors are defined as pelvic lymphnode involvement and/ or parametrial extension 2.Performance status: 0-2 3.Age: 20-74 years old 4.Patients without severe dysfunction of major organs 5.Patients can be alive over 3 months after treatment 6.Signed informed consent must be obtained

Exclusion criteria

Exclusion criteria: 1.Patients with fever over 38.0 2.Patients with infection or more than WBC:12,000/mm3 3.Patients with severe complications 4.Patients with double cancer 5.Patients with massive pleural effusion, ascites and pericardiac fluid need to continuous drainage 6.Patients with neuropathy more than grade 1 7.Patients with edema more than grade 1, except for cervical adenocarcinoma 8.Patients with hypersensitivity reactions to taxane compound, carboplatin or polysorbate 80 9.Patients received neoadjuvant chemotherapy 10.Patients judged as the exclusive case by the investigator

Design outcomes

Primary

MeasureTime frame
2-year Progression free survival

Secondary

MeasureTime frame
Drug adverse effect, Compliance

Countries

Japan

Contacts

Public ContactMuneaki Shimada

Faculty of Medicine, Tottori University Department of Obstetrics and Gynecology

mshima12@med.tottori-u.ac.jp0859-38-6647

Outcome results

None listed

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