Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075712
• Other study ID #: RCOG-MRC-CHORUS
• Secondary ID: CDR0000347463EU-
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 9, 2004
• Last updated: August 9, 2013
• Start date: September 2003

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before and after surgery works and compares it to giving chemotherapy after surgery alone in treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• carboplatin

• paclitaxel

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	North Devon District Hospital	Barnstaple	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Centre for Cancer Research and Cell Biology at Queen's University Belfast	Belfast	Northern Ireland
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Bradford Royal Infirmary	Bradford	England
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Broomfield Hospital	Broomfield	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Royal Derby Hospital	Derby	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Birmingham Women's Hospital	Edgbaston	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Frimley Park Hospital	Frimley	England
United Kingdom	Queen Elizabeth Hospital	Gateshead	England
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Hereford Hospitals	Hereford	England
United Kingdom	Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Hull	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Royal Lancaster Infirmary	Lancaster	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester General Hospital	Leicester	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Liverpool Women's Hospital	Liverpool	England
United Kingdom	Barts and the London School of Medicine	London	England
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Medical Research Council Clinical Trials Unit	London	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	St. Mary's Hospital	Manchester	England
United Kingdom	Wythenshawe Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Whiston Hospital	Prescot Merseyside	England
United Kingdom	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Royal Hallamshire Hospital	Sheffield	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	Staffordshire General Hospital	Stafford	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent	England
United Kingdom	St. Peter's Hospital	Surrey	England
United Kingdom	South West Wales Cancer Institute	Swansea	Wales
United Kingdom	Great Western Hospital	Swindon	England
United Kingdom	Taunton and Somerset Hospital	Taunton Somerset	England
United Kingdom	Torbay Hospital	Torquay	England
United Kingdom	Walsall Manor Hospital	Walsall	England
United Kingdom	Good Hope Hospital	West Midlands	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England
United Kingdom	Wrexham Maelor Hospital	Wrexham	Wales
United Kingdom	Yeovil District Hospital	Yeovil	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Obstetricians and Gynecologists

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 3 years			No
Primary	Progression-free survival			No
Primary	Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28)			No