Sequential schedule of platinum then paclitaxel-based chemotherapy for women with epithelial non-mucinous advanced inoperable peritoneal malignancy

A randomised feasibility study of extended chemotherapy with neoadjuvant carboplatin, then surgery followed by adjuvant paclitaxel and gemcitabine versus neoadjuvant gemcitabine and carboplatin, then surgery, followed by adjuvant paclitaxel for women with epithelial non-mucinous advanced inoperable peritoneal malignancy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN24742183

Enrollment

Registered

2006-12-14

Start date

2007-12-03

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced, inoperable ovarian cancer (epithelial non-mucinous advanced inoperable peritoneal malignancy) Cancer Ovarian cancer

Interventions

Group one: six cycles of chemotherapy with neoadjuvant carboplatin, then surgery, followed by six cycles of adjuvant paclitaxel and gemcitabine Group two: six cycles of neoadjuvant gem

the initial sponsor at the time of registration was the University of Birmingham (UK).

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Clinical, radiological, histological and findings consistent with a diagnosis of International Federation of Gynecology and Obstetrics (FIGO) stage 3C/4 primary epithelial ovarian cancer, primary peritoneal carcinoma, ovarian carcinosarcoma, or fallopian tube carcinoma 2. Patients (aged 18 - 75 years) will be unsuitable for primary debulking surgery as defined by laparoscopic staging procedures, supplemented by clinical and radiological assessments 3. Eastern Cooperative Oncology Group (ECOG) performance status zero, one, two or three

Exclusion criteria

Exclusion criteria: 1. Prior malignancy, chemotherapy or radiotherapy 2. Known brain metastases 3. Poorly controlled potentially serious medical conditions likely to render treatment compliance with the protocol difficult 4. Those of child-bearing potential not employing adequate contraception, which may include prescription contraceptives

Design outcomes

Primary

Measure	Time frame
The percentage of patients completing 12 cycles of chemotherapy in each study arm, considered separately.	—

Secondary

Measure	Time frame
1. Toxicities 2. Quality of life 3. Objective response rate to the induction phase of chemotherapy (first six cycles) assessed on Computed Tomography (CT), clinically, at surgery, and using CA-125 tumour marker 4. Objective response rate following all 12 (six plus six) cycles of treatment, assessed clinically, on CT and using CA-125 5. Progression-free and overall survival, particularly at 34 weeks (end of treatment) These will be assessed separately for each treatment arm.	—

Measure

Time frame

1. Toxicities 2. Quality of life 3. Objective response rate to the induction phase of chemotherapy (first six cycles) assessed on Computed Tomography (CT), clinically, at surgery, and using CA-125 tumour marker 4. Objective response rate following all 12 (six plus six) cycles of treatment, assessed clinically, on CT and using CA-125 5. Progression-free and overall survival, particularly at 34 weeks (end of treatment) These will be assessed separately for each treatment arm.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026