Fallopian Tube CancerPhase 2/3NCT00075712
Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase 2/3 study testing carboplatin, paclitaxel and adjuvant therapy in people with Fallopian Tube Cancer and Ovarian Cancer, run by Royal College of Obstetricians and Gynecologists at 70 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- carboplatin, paclitaxel and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 70 sitesUnited Kingdom
- Study dates
- Sep 2003to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
70 sites in 1 country.
70 sites in 1 country
United Kingdom70 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
North Devon District Hospital
Barnstaple, England, EX31 4JB
Royal United Hospital
Bath, England, BA1 3NG
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7BL
Blackpool Victoria Hospital
Blackpool, England, FY3 8NR
Bradford Royal Infirmary
Bradford, England, BD9 6RJ
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Broomfield Hospital
Broomfield, England, CM1 7ET
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF4 7XL
Cumberland Infirmary
Carlisle, England, CA2 7HY
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Essex County Hospital
Colchester, England, C03 3NB
Walsgrave Hospital
Coventry, England, CV2 2DX
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Royal Derby Hospital
Derby, England, DE22 3NE
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Birmingham Women's Hospital
Edgbaston, England, B15 2TG
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Frimley Park Hospital
Frimley, England, GU16 5UJ
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Hereford Hospitals
Hereford, England, HR1 2ER
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Ipswich Hospital
Ipswich, England, IP4 5PD
Royal Lancaster Infirmary
Lancaster, England, LA1 4RP
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester General Hospital
Leicester, England, LE5 4PW
Lincoln County Hospital
Lincoln, England, LN2 5QY
Liverpool Women's Hospital
Liverpool, England, L8 7SS
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Barts and the London School of Medicine
London, England, EC1M 6GR
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
St. George's Hospital
London, England, SW17 0QT
Royal Marsden - London
London, England, SW3 6JJ
Hammersmith Hospital
London, England, W12 OHS
St. Mary's Hospital
Manchester, England, M13 0JH
Christie Hospital
Manchester, England, M20 4BX
Wythenshawe Hospital
Manchester, England, M23 9LJ
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Northampton General Hospital
Northampton, England, NN1 5BD
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Oxford Radcliffe Hospital
Oxford, England, 0X3 7LJ
Derriford Hospital
Plymouth, England, PL6 8DH
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD
Whiston Hospital
Prescot Merseyside, England, L35 5DR
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, PR2 9HT
Oldchurch Hospital
Romford, England, RM7 OBE
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S10 2SJ
Royal Hallamshire Hospital
Sheffield, England, S1O 2JF
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
Staffordshire General Hospital
Stafford, England, ST16 3SA
University Hospital of North Staffordshire
Stoke-on-Trent, England, ST4 7LN
St. Peter's Hospital
Surrey, England, KT 16 OPZ
South West Wales Cancer Institute
Swansea, Wales, SA2 8QA
Great Western Hospital
Swindon, England, SN3 6BB
Taunton and Somerset Hospital
Taunton Somerset, England, TA1 5DA
Torbay Hospital
Torquay, England, TQ2 7AA
Walsall Manor Hospital
Walsall, England, WS2 9PS
Good Hope Hospital
West Midlands, England, B75 7RR
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
Yeovil District Hospital
Yeovil, England, BA21 4AT
About this study
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
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.
Read the 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.
- Being tested
- carboplatin, paclitaxel, adjuvant therapy, conventional surgery, neoadjuvant therapy
- Keywords
- 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
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
paclitaxelDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 3 years
Progression-free survival
Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2004 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Obstetricians and Gynecologists
- Sponsor type
- University, hospital or other
- Investigators
- Sean Kehoe, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075712
- Sponsor's protocol ID
- RCOG-MRC-CHORUS
- Other IDs
- CDR0000347463, EU-20350, ISRCTN74802813
- Status last verified
- May 2007
- First submitted
- 9 Jan 2004
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00075712
- Acronym / sponsor ID
- RCOG-MRC-CHORUS
- Keywords
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal College of Obstetricians and GynecologistsUniversity, hospital or other
- Study start
- Sep 2003
- First posted
- 13 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Overall survival at 3 years
Progression-free survival
Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Related trials for Fallopian Tube Cancer
RecruitingPhase 2
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RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Kehoe principal investigator
Oxford University Hospitals NHS Trust
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing carboplatin, paclitaxel and adjuvant therapy in people with Fallopian Tube Cancer and Ovarian Cancer, run by Royal College of Obstetricians and Gynecologists at 70 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 3 years. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.