Completed

A Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Abdominal Neoplasms+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorRoyal College of Obstetricians and Gynecologists
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the feasibility of a randomized trial to determine the impact of the timing of surgery and chemotherapy in patients with newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer. OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary surgery, patients receive chemotherapy comprising carboplatin alone or in combination with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo interval debulking surgery after the third course of chemotherapy. * Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3 courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6 weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm I. Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18 months.

Official TitleA Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma 
NCT00075712
Principal SponsorRoyal College of Obstetricians and Gynecologists
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Abdominal NeoplasmsUrogenital DiseasesGenital DiseasesAdnexal DiseasesDigestive System DiseasesDigestive System NeoplasmsFallopian Tube DiseasesFallopian Tube NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SitePeritoneal DiseasesPeritoneal NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

DISEASE CHARACTERISTICS: * Newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer * Clinical and imaging evidence of a pelvic mass with extrapelvic metastases within the past 4 weeks * Serum CA 125/CEA ratio \> 25 * Plans to receive carboplatin-based chemotherapy PATIENT CHARACTERISTICS: Age * Adult Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Considered fit to undergo protocol treatment and follow-up * No other prior or concurrent malignancy that would preclude study treatment or comparisons PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 70 locations

Suspended

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, United KingdomSee the location
Suspended

North Devon District Hospital

Barnstaple, United Kingdom
Suspended

Royal United Hospital

Bath, United Kingdom
Suspended

Blackpool Victoria Hospital

Blackpool, United Kingdom
Completed70 Study Centers