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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075712
First received: January 9, 2004
Last updated: August 9, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: carboplatin
Drug: paclitaxel
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 3 years [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28) [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2003
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075712

  Hide Study Locations
Locations
United Kingdom
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
North Devon District Hospital
Barnstaple, England, United Kingdom, EX31 4JB
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
Blackpool Victoria Hospital
Blackpool, England, United Kingdom, FY3 8NR
Bradford Royal Infirmary
Bradford, England, United Kingdom, BD9 6RJ
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Broomfield Hospital
Broomfield, England, United Kingdom, CM1 7ET
Cumberland Infirmary
Carlisle, England, United Kingdom, CA2 7HY
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Essex County Hospital
Colchester, England, United Kingdom, C03 3NB
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Royal Derby Hospital
Derby, England, United Kingdom, DE22 3NE
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Birmingham Women's Hospital
Edgbaston, England, United Kingdom, B15 2TG
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Frimley Park Hospital
Frimley, England, United Kingdom, GU16 5UJ
Queen Elizabeth Hospital
Gateshead, England, United Kingdom, NE9 6SX
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 7XX
Hereford Hospitals
Hereford, England, United Kingdom, HR1 2ER
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Royal Lancaster Infirmary
Lancaster, England, United Kingdom, LA1 4RP
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester General Hospital
Leicester, England, United Kingdom, LE5 4PW
Lincoln County Hospital
Lincoln, England, United Kingdom, LN2 5QY
Liverpool Women's Hospital
Liverpool, England, United Kingdom, L8 7SS
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Hammersmith Hospital
London, England, United Kingdom, W12 OHS
Barts and the London School of Medicine
London, England, United Kingdom, EC1M 6GR
Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LJ
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
St. Mary's Hospital
Manchester, England, United Kingdom, M13 0JH
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom, MK6 5LD
Northampton General Hospital
Northampton, England, United Kingdom, NN1 5BD
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 7LJ
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Dorset Cancer Centre
Poole Dorset, England, United Kingdom, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom, PO3 6AD
Whiston Hospital
Prescot Merseyside, England, United Kingdom, L35 5DR
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S1O 2JF
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S10 2SJ
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom, SY3 8XQ
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom, SL2 4HL
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
University Hospital of North Staffordshire
Stoke-On-Trent, England, United Kingdom, ST4 7LN
St. Peter's Hospital
Surrey, England, United Kingdom, KT 16 OPZ
Great Western Hospital
Swindon, England, United Kingdom, SN3 6BB
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom, TA1 5DA
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA
Walsall Manor Hospital
Walsall, England, United Kingdom, WS2 9PS
Good Hope Hospital
West Midlands, England, United Kingdom, B75 7RR
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Yeovil District Hospital
Yeovil, England, United Kingdom, BA21 4AT
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT9 7BL
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Ysbyty Gwynedd
Bangor, Wales, United Kingdom, LL57 2PW
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF4 7XL
South West Wales Cancer Institute
Swansea, Wales, United Kingdom, SA2 8QA
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom, LL13 7TD
Sponsors and Collaborators
Royal College of Obstetricians and Gynecologists
Investigators
Principal Investigator: Sean Kehoe Oxford University Hospitals NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00075712     History of Changes
Other Study ID Numbers: RCOG-MRC-CHORUS, CDR0000347463, EU-20350, ISRCTN74802813
Study First Received: January 9, 2004
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
stage IIIA fallopian tube cancer
stage IIIB fallopian tube cancer
stage IIIC fallopian tube cancer
stage IV fallopian tube cancer
stage IIIA primary peritoneal cavity cancer
stage IIIB primary peritoneal cavity cancer
stage IIIC primary peritoneal cavity cancer
stage IV primary peritoneal cavity cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014