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Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix Clinical research trials and Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix health trials take place in a lot of 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 potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix  Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
For Condition: stage 1B cervical cancer,cervical adenocarcinoma,cervical squamous cell carcinoma,cervical adenosquamous cell carcinoma
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.
Details: OBJECTIVES: - Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy. - Compare the toxicity of these regimens in these patients. - Compare the health-related quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted. - Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery. - Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses. - Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy. - Group 3: Patients receive further treatment at the discretion of the investigator. - Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery. - Group A: Patients receive treatment as in group 1 above without intracavity irradiation. - Group B: Patients receive treatment as in group 2 above without intracavity irradiation. - Group C: Patients receive no further treatment. - Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses. Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types: - Squamous cell carcinoma - Adenocarcinoma - Adenosquamous carcinoma - Primary, previously untreated disease - Exophytic cervical lesions greater than 4 cm in diameter OR - Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer - No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations) - No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection) - Eligible for radical hysterectomy and lymph node dissection PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times normal - SGOT no greater than 3 times normal - Alkaline phosphatase no greater than 3 times normal Renal - Creatinine no greater than 2.0 mg/dL - No renal abnormalities requiring modification of radiation fields Gastrointestinal - No gastrointestinal bleeding - No intestinal obstruction Other - Not pregnant - Negative pregnancy test - No septicemia or severe infection - No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer - No circumstances that would preclude study completion or required follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics - No prior hysterectomy (total or subtotal)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottMcMeekin, Study Chair, Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612-3824
United States
Recruiting Howard Strassner 312-942-6723
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
University of Oklahoma College of Medicine *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting Robert Mannel 405-271-8787
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Tacoma General Hospital *Recruiting*
Tacoma, Washington, 98405
United States
Recruiting Roger Lee 253-403-1029
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8028
United States
Recruiting Peter Schwartz 203-785-4014
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0526
United States
Recruiting Nader Husseinzadeh 513-558-8450
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Gavin Stuart 403-944-1721
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9032
United States
Recruiting David Miller 214-648-3026
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5001
United States
Recruiting G. Rose 202-782-8515
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01605-2982
United States
Recruiting Susan Zweizig 508-334-1160
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting S. Yamada 773-702-6722
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Robert Burger 714-456-7971
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0587
United States
Recruiting Edward Hannigan 409-772-3368
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905-0001
United States
Recruiting Harry Long 507-284-4320
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Kenneth Noller 617-636-2382
State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting Michael Pearl 631-444-2774
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting James Fiorica 813-972-8478
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Willie Andersen 434-924-9333
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Anthony Evans 715-389-3101
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Mark Morgan 215-662-6043
Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11790-7775
United States
Recruiting Michael Pearl 631-444-2774
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44124
United States
Recruiting Peter Rose 216-444-1712
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Frederick Ueland 606-257-1613
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Katherine Look 317-274-8987
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Wesley Fowler 919-966-1196
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Abington Memorial Hospital *Recruiting*
Abington, Pennsylvania, 19001-3788
United States
Recruiting Parviz Hanjani 215-885-0220
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Michael Bookman 215-728-2987
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103-1489
United States
Recruiting David Warshal 856-342-2185
Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos, California, 95032
United States
Recruiting Nick Spirtos 408-866-3843
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Andrew Menzin 516-562-4438
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1740
United States
Recruiting Jonathan Berek 310-206-5161
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Stephanie King 215-762-2640
Australia New Zealand Gynaecological Oncology Trials Group *Recruiting*
Camperdown, New South Wales, 1450
Australia
Recruiting Michael Friedlander 61-2-9562-1450
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Daniel Clarke-Pearson 919-684-3765
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting George Olt 717-531-8144
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Francis Major 303-388-4876
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Keesler Medical Center - Keesler Air Force Base *Recruiting*
Keesler AFB, Mississippi, 39534-2576
United States
Recruiting John Bomalaski 228-377-6396
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Sara Crowder 573-882-1057
Kagoshima City Hospital *Recruiting*
Kagoshima City, , 892-8580
Japan
Recruiting Masayuki Hatae 81-99-224-2101
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Carol Brown 212-639-7659
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting Joel Sorosky 319-356-2015
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Linda Carson 612-626-3347
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1065
United States
Recruiting Brigitte Miller 336-716-6673
Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Cheung Wong 802-847-5110
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting David Mutch 314-362
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Mack Barnes 205-934-0930
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Jeffrey Fowler 614-293-8737
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Benjamin Greer 206-685-2463
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Charles Levenback 713-745-2563
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6188
United States
Recruiting Ellen Hartenbach 608-263-1209
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Steven Waggoner 216-844-5011
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Gynecologic Oncology Network *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Howard Homesley 615-804-2216
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Additional Information:
Study ID Numbers: CDR0000269821; GOG-0201
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054067
Other Cervical Squamous Cell Carcinoma Studies:
1. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
2. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
3. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
4. Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer
5. Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Related Studies:
Other cervical squamous cell carcinoma Clinical Trials
Other Mississippi Clinical Trials
Other Jackson Clinical Trials
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
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