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Phase II trial of dose dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer

Phase II trial of dose dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer - KCOG-G-1301 trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017138
Enrollment
48
Registered
2015-04-20
Start date
2015-04-20
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

Advanced or recurrent uterine corpus cancer

Interventions

Paclitaxel 80mg/m2 day1, 8, 15+ Carboplatin AUC 6 day1 every 3 weeks

Sponsors

Kansai Clinical Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1),2),7);Women 20-75 years of age with histologically confirmed uterine corpus cancer, as endometrioid carcinoma, serous carcinoma, mucinous carcinoma, clear cell carcinoma, squamous cell carcinoma, traditional cell carcinoma, carcinosarcoma, or undifferentiated carcinoma. A) Patients with FIGO stage III had residual tumor. B) FIGO stage IV. C) Recurrence after first-line radical treatment. D) Recurrence after second line chemotherapy or radiotherapy. 3), 6) No prior therapy, over 6 months after chemotherapy with platinum plus taxane (only one regimen was permitted), or over 3 months chemotherapy after non-platinum and non-taxane chemotherapy. 4)Measurable lesion 5)No bilateral hydronephrosis 8)Performance status (ECOG);0-2 9)laboratory date in two weeks a) neutrophil; more than 1500/mm3 b) platelet; morethan 100000/mm3 c) hemoglobin; more than 10g/dl d) total bilirubin; more than 1.5mg/dl e) serum creatinine; less than1.5mg/dl f) Ccr calculated by Cockcroft's formula; more than 50ml/min 10) life expectancy of more than 3 months 11) written informed consent

Exclusion criteria

Exclusion criteria: 1)motor or sensory neuropathy with dysfunction 2) alcoholic hypersensitivity 3)bacterial infection to needtreatment 4) myocardial infarction within 6 months 5) unstable angina 6) poor control diabetes 7) active multiple malignancy 8) Interstitial pneumonia, pulmonary fibrosis 9) Paclitaxel or CBDCA is contra-indicated. 10) HBs-Ag(+) 11) Paralytic or mechanical bowel obstruction 12) History of severe drug-induced hypersensitivity syndrome 13) Any other cases who are regarded as inadequate for study enrollment by investigators.

Design outcomes

Primary

MeasureTime frame
response rate

Countries

Japan

Contacts

Public ContactKensuke Hori

Kansai Rosai Hospital obgy

hori-kensuke@kansaih.johas.go.jp+81-6-6416-1221

Outcome results

None listed

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