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Phase II study of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel (dose dense TC therapy) for locally advanced cervical cancer

Phase II study of pre and post operative combination chemotherapy using carboplatin and dose dense paclitaxel (dose dense TC therapy) for locally advanced cervical cancer - SGSG016 study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015184
Enrollment
50
Registered
2014-09-18
Start date
2014-09-18
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

FIGO stage Ib2, IIa2, or IIb cervical cancer

Interventions

Carboplatin AUC6 (Day1), Paclitaxel 80mg/m2 (Day1, 8, 15) Q21 Days 3 cycles (Neoadjuvant) Type III hysterectomy Carboplatin AUC6 (Day1), Paclitaxel 80mg/m2 (Day1, 8, 15) Q21 Days 3 cycles (Adjuvant)

Sponsors

Sankai Gynecology Study Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed cervical cancer. 2. FIGO stage Ib2, IIa2, or IIb. 3. ECOG performance status: 0 to 2 4. Patient with adequate organ function.

Exclusion criteria

Exclusion criteria: 1. Prior chemotherapy nor radiation therapy for cervical cancer. 2. Simultaneous active cancer. 3. Serious coexisting illness 4. Carrier of viral hepatitis 5. Active infection 6. Interstitial pneumonia

Design outcomes

Primary

MeasureTime frame
2 year recurrence free survival

Secondary

MeasureTime frame
objective response rate, pathological response rate, 2 year overall survival, toxicity, site of recurrence, completion rate of protocol therapy

Countries

Japan

Contacts

Public ContactSHOJI NAGAO

Hyogo Cancer Center Gynecologic Oncology

nagao@hp.pref.hyogo.jp078-929-1151

Outcome results

None listed

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