Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma (Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer)

Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma (Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer) - Randomized Trial of tri-weekly TJ vs. weekly TJ for Stage II-IV Mullerian Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000183

Enrollment

600

Registered

2005-09-15

Start date

2003-04-01

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

Patients with stageII-IV Mullerian Carcinoma (Ovarian Epithelial,Primary Peritoneal,or Fallopian Tube Cancer)

Interventions

combination of paclitaxel and carboplatin PTX180mg/m2, day1+CBDCA AUC6.0 day1 every 21 days for 6-9cycles combination of paclitaxel and carboplatin PTX80mg/m2 day1,8,15+CBDCA AUC6.0 day1 every 2

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: I. Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer II. No prior chemotherapy III. Age: 20 and more IV. Performance status: ECOG 0-2 V. 1) Absolute neutrophil count at least 1,500/mm3 2) Platelet count at least 100,000/mm3 3) Bilirubin less than 1.5mg/dL 4) SGOT less than 100 IU/l 5) Serum creatinine less than 1.5mg/dL VI. Written informed consent

Exclusion criteria

Exclusion criteria: I. Patients with ovarian borderline tumor II. Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer those are curable with local therapy III. Patients with active infection or uncontrolled diabetes IV. Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication V. Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)

Design outcomes

Primary

Measure	Time frame
Progression-free Survival	—

Secondary

Measure	Time frame
Overall Suvival/Adverse event/Clinical Objective Response/Quality of life	—

Countries

Japan

Contacts

Public ContactNoriyuki Katsumata ,M.D.

JGOG3016 Coordinating Office National Cancer Center Hospital

nkatsuma@ncc.go.jp03-3542-2511

Outcome results

None listed

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