|
Combination Chemotherapy in Treating Women With Resected Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy in Treating Women With Resected Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Women With Resected Breast Cancer Clinical research trials and Combination Chemotherapy in Treating Women With Resected Breast Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy in Treating Women With Resected Breast Cancer. Combination Chemotherapy in Treating Women With Resected Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Women With Resected Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy in Treating Women With Resected Breast Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Women With Resected Breast Cancer  Combination Chemotherapy in Treating Women With Resected Breast Cancer
Combination Chemotherapy in Treating Women With Resected Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapyregimen is more effective in treating resectedstage I or stage II breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.
Details: OBJECTIVES: - Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel. - Compare the acute toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms. - Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens. - Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC) IV on day 1. Treatment repeats every 3 weeks for 8 courses. - Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF). Treatment with CMF repeats every 4 weeks for 4 courses. - Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I, regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses. Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy (START) trial receive localized radiotherapy once daily, 5 days a week, for 3-5 weeks, according to local practice. Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily for at least 5 years. Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated - No clinical or radiological evidence of locoregional or metastatic disease - No locally advanced tumors at diagnosis, indicated by any of the following: - Fixed tumors - Peau d'orange skin changes - Skin ulceration - Inflammatory changes (T4 or T3b, N2 disease) - No male breast cancer - No prior invasive breast cancer or bilateral breast cancer - Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed - Must begin study chemotherapy within 8 weeks after definitive surgery - Hormone receptor status: - Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Age: - Over 18 Sex: - Female Menopausal status: - Not specified Performance status: - WHO 0-1 Life expectancy: - At least 2 years Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin normal - AST no greater than 1.5 times normal - Alkaline phosphatase no greater than 1.5 times normal Renal: - Creatinine no greater than 1.5 times normal Cardiovascular: - No myocardial infarction within the past 6 months - No congestive heart failure Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix - No other serious medical illness that would limit life expectancy - No psychiatric condition that would preclude informed consent - No active uncontrolled bacterial, viral, or fungal infection PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - See Disease Characteristics - No prior cytotoxic chemotherapy Endocrine therapy: - No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy - No concurrent hormone replacement therapy Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics Other: - At least 4 weeks since any prior unlicensed drugs - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulEllis, Study Chair, Guy's Hospital
Maidstone Hospital *Recruiting*
Maidstone, England, ME16 9QQ
United Kingdom
Recruiting C. Abson 01622-729000, ext.5014
Oxford Radcliffe Hospital *Recruiting*
Oxford, England, 0X3 9DU
United Kingdom
Recruiting Adrian Harris 44-1865-226-184
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting John Yarnold 44-20-8661-3388
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Andrew Last 44-23-8063-4288
West Suffolk Hospital *Recruiting*
Bury St. Edmunds, England, IP33 2QZ
United Kingdom
Recruiting Margaret Moody 44-1284-713-571
Broomfield Hospital *Recruiting*
Chelmsford, Essex, England, CM1 5ET
United Kingdom
Recruiting N.P.G. Davidson 44-1245-440-761
Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Recruiting Anne Robinson 44-1702-221-226
Royal Devon and Exeter Hospital *Recruiting*
Exeter, England, EX2 5DW
United Kingdom
Recruiting Andrew Goodman 44-1392-411-611
Glan Clywd District General Hospital *Recruiting*
Rhyl, Denbighshire, Wales, LL 18 5UJ
United Kingdom
Recruiting Jill Bishop 44-1745-445-154
Queen Elizabeth Hospital *Recruiting*
King's Lynn, England, PE30 4ET
United Kingdom
Recruiting Athar Ahmad 44-1553-613-684
St. Luke's Cancer Center *Recruiting*
Guildford, England, GU2 5XX
United Kingdom
Recruiting Stephen Houston 44-1483-571-122 ext. 6744
Royal Sussex County Hospital *Recruiting*
Brighton, England, BN2 5BF
United Kingdom
Recruiting David Bloomfield 44-1273-696-955 ext. 7686
University of Cambridge *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Helena Earl 44-1223-274-312
Royal Preston Hospital *Recruiting*
Preston, England, PR2 9HT
United Kingdom
Recruiting S. Kumar 44-1772-710-089
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting D. Dodwell 44-113-392-6788
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Mette Lindegaard 32-16-34-6900
New Cross Hospital *Recruiting*
Wolverhampton, England, WV10 0QP
United Kingdom
Recruiting M. Churn 01902-642978
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting A. Bowman 44-131-537-2196
Belfast City Hospital Trust Incorporating Belvoir Park Hospital *Recruiting*
Belfast, Northern Ireland, BT8 8JR
United Kingdom
Recruiting Jackie Clarke 44-2890-699-069
Cheltenham General Hospital *Recruiting*
Cheltenham, England, GL53 7AN
United Kingdom
Recruiting Kim Benstead 44-8454-223-510
Royal Berkshire Hospital *Recruiting*
Reading, England, RG1 5AN
United Kingdom
Recruiting J. Barrett 44-118-987-7878
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Robert Coleman 44-114-226-5213
Essex County Hospital *Recruiting*
Colchester, England, C03 3NB
United Kingdom
Recruiting Philip Murray 44-0120-674-7474
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Chris Cottrill 44-20-7601-8391
Alexandra Healthcare NHS *Recruiting*
Redditch, Worcestershire, England, B98 7UB
United Kingdom
Recruiting C. Irwin 44-015-2750-3030
Queen Elizabeth Hospital at University of Birmingham *Recruiting*
Birmingham, England, B15 2TH
United Kingdom
Recruiting Christopher Poole 44-121-472-1311
Torbay Hospital *Recruiting*
Torquay Devon, England, TQ2 7AA
United Kingdom
Recruiting Nigel Bailey 441803655052
Guy's Hospital *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Paul Ellis 44-207-955-5000 ext. 5816
Charing Cross Hospital *Recruiting*
London, England, W6 8RF
United Kingdom
Recruiting Charles Lowdell 44-20-8846-1478
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting S. Goodman 0117-928-2418
North Devon District Hospital *Recruiting*
Barnstaple, England, EX31 4JB
United Kingdom
Recruiting Mark Napier 44-1884-821747
Diana Princess of Wales Hospital *Recruiting*
Grimsby, England, DN33 2BA
United Kingdom
Recruiting Paul Mack 44-1472-874-111
Huddersfield Royal Infirmary *Recruiting*
Huddersfield, West Yorks, England, HD3 3EA
United Kingdom
Recruiting Barbara Crosse 0484-342999
Royal United Hospital *Recruiting*
Bath, England, BA1 3NG
United Kingdom
Recruiting Hugh Newman 44-1225-824797
Singleton Hospital *Recruiting*
Swansea, Wales, SA 2 8QA
United Kingdom
Recruiting Theo Joannides 44-1792-205-666
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF14 2TL
United Kingdom
Recruiting Peter Barrett Lee 44-29-2061-5888
Salisbury District Hospital *Recruiting*
Salisbury, England, SP2 8BJ
United Kingdom
Recruiting Rosemary Gregory 44-1722-429-384
Pilgrim Hospital *Recruiting*
Boston, England, PE21 9QT
United Kingdom
Recruiting Elisabeth Murray 44-1205-364-801
Walsgrave Hospital *Recruiting*
Coventry, England, CV2 2DX
United Kingdom
Recruiting Robert Grieve 24-76-535-020
Taunton and Somerset Hospital *Recruiting*
Taunton Somerset, England, TA1 5DA
United Kingdom
Recruiting J.D. Graham 1823 342418
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Peter Canney 44-141-211-1743
North Staffs Royal Infirmary *Recruiting*
Stoke on Trent, England, ST4 7LN
United Kingdom
Recruiting Murray Brunt 44-1782-554-588
St. Georges Hospital Medical School *Recruiting*
London, England, SW17 ORE
United Kingdom
Recruiting J. Mansi 44-171-784-7092
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting S. Khanna 44-116-254-1414
City Hospital - Birmingham *Recruiting*
Birmingham, England, B18 7QH
United Kingdom
Recruiting Daniel Rea 44-121-507-5241
Bronglais General Hospital *Recruiting*
Sutton, England, SY23 1ER
United Kingdom
Recruiting Alan Axford 44-970-635-748
Meyerstein Institute of Oncology at Middlesex Hospital *Recruiting*
London, England, WIT 3AA
United Kingdom
Recruiting Mark Gaze 207-6-36-83-33
Blackpool Victoria Hospital *Recruiting*
Blackpool, England, FY3 8NR
United Kingdom
Recruiting Linda Evans 44-20-7210-4850
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting A. Hutcheon 44-1224-681-818
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Marcia Hall 44-1923-844-533
Royal Free Hospital *Recruiting*
Hampstead, London, England, NW3 2QG
United Kingdom
Recruiting A.L. Jones 44-171-830-2184
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting J. Brock 44-151-334-1155
Royal Infirmary *Recruiting*
Glasgow, Scotland, G4 0SF
United Kingdom
Recruiting Mike Soukop 44-141-211-1160
Bradford Hospitals NHS Trust *Recruiting*
Bradford, England, BD9 6RJ
United Kingdom
Recruiting Chris Bradley 44-1274-542-200
Northampton General Hospital NHS Trust *Recruiting*
Northampton, England, NN6 8BJ
United Kingdom
Recruiting C. MacMillan 44-1604-545-225
Princess Royal Hospital *Recruiting*
Hull, England, HU8 9HE
United Kingdom
Recruiting A. Chaturvedi 44-1482-67-66-23
Scunthorpe General Hospital *Recruiting*
Scunthorpe, England, DN15 7BH
United Kingdom
Recruiting S. Sreenivasan 44-1724-282-282
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Tim Perren 44-113-206-4670
Portsmouth Oncology Centre at Saint Mary's Hospital *Recruiting*
Portsmouth Hants, England, PO3 6AD
United Kingdom
Recruiting Joseph Frank 44-23-9228-6000
Oldchurch Hospital *Recruiting*
Romford, England, RM7 OBE
United Kingdom
Recruiting M. Quigley 44-1708-708-270
Derbyshire Royal Infirmary *Recruiting*
Derby, England, DE1 2QY
United Kingdom
Recruiting Pamela Woodings 01-332-347-141 ext. 4575
Hairmyres Hospital *Recruiting*
East Kilbride, Scotland, G75 8RG
United Kingdom
Recruiting Hosney Yosef 44-1355-220-292
Royal Shrewsbury Hospital *Recruiting*
Shrewsbury, England, SY3 8XO
United Kingdom
Recruiting Rajiv Agrawal 01743-261334
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting J.A. Dewar 44-1382-660-111
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Alan Stewart 44-161-446-3000
Raigmore Hospital *Recruiting*
Inverness, Scotland, 1V2 3UJ
United Kingdom
Recruiting Mumtaz Elia 44-1463-704-000 ext. 4310
Ipswich Hospital NHS Trust *Recruiting*
Ipswich, England, IP4 5PD
United Kingdom
Recruiting John Vay 44-014-7371-2233
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting J. Bozzino 44-191-219-4200
Peterborough Hospitals Trust *Recruiting*
Peterborough, England, PE3 6DA
United Kingdom
Recruiting Karen McAdam 44-1733-874-255
Additional Information:
Study ID Numbers: CDR0000069311; ICR-TACT,EU-20109
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033683
Other Stage 2 Breast Cancer Studies:
1. Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer
2. Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
3. Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
4. Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
5. Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other England Clinical Trials
Other Westcliff-On-Sea Clinical Trials
Combination Chemotherapy in Treating Women With Resected Breast Cancer
|
|
|
|
|
|
|
|
