Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
Status: | Completed |
---|---|
Conditions: | Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/28/2019 |
Start Date: | March 2006 |
End Date: | December 2016 |
A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma
RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy
(IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor
cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with
or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to
the pelvis with or without chemotherapy works in treating patients with endometrial cancer or
cervical cancer that has been removed by surgery.
(IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor
cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin,
work in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with
or without chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to
the pelvis with or without chemotherapy works in treating patients with endometrial cancer or
cervical cancer that has been removed by surgery.
OBJECTIVES:
- Determine the transportability of intensity modulated radiotherapy (IMRT) to a
multi-institutional setting in patients with resected endometrial or cervical cancer.
- Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus
standard treatments.
- Assess adverse events related to this regimen.
- Estimate the rates of local-regional control, distant metastasis, and disease-free and
overall survival.
- Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for
5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day
1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then
every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3
years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
- Determine the transportability of intensity modulated radiotherapy (IMRT) to a
multi-institutional setting in patients with resected endometrial or cervical cancer.
- Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus
standard treatments.
- Assess adverse events related to this regimen.
- Estimate the rates of local-regional control, distant metastasis, and disease-free and
overall survival.
- Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(cervical vs endometrial cancer).
All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for
5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day
1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks post-IMRT and then
every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3
years.
PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Must have undergone a hysterectomy (total abdominal, vaginal, radical, or
laparoscopic-assisted vaginal) within 7 weeks prior to study entry
- Patients with endometrial cancer must have also undergone a bilateral
salpingo-oophorectomy
- Histologically confirmed diagnosis of 1 of the following:
- Endometrial cancer meeting 1 of the following criteria:
- Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative
pelvic radiotherapy
- Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
- Stage IIIC with all of the following:
- Pelvic lymph node positive only
- Para-aortic nodes sampled negative
- Not receiving chemotherapy
- Cervical cancer meeting 1 of the following criteria:
- Post-radical hysterectomy and requires postoperative pelvic radiotherapy due
to any of the following:
- Positive pelvic nodes (negative para-aortic nodes)
- Microscopic parametrial involvement and negative margins
- Disease qualified by Sedlis criteria must have 2 of the following risk
factors:
- 1/3 or more stromal invasion
- Lymph-vascular space invasion
- Large clinical tumor diameter (≥ 4 cm)
- Post-simple hysterectomy with negative margins and negative nodes by CT
scan, MRI, or positron emission tomography-CT scan
- No requirement for extended-field radiotherapy beyond the pelvis
- No histologically confirmed papillary serous, clear cell, or neuroendocrine (either
large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or
malignant müllerian mixed tumor
- No evidence of metastatic disease outside of the pelvis
- No microscopic involvement of the resection margin (< 3 mm)
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
- Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
- Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
- Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
- Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
- AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
- Bilirubin ≤ 2 times upper limit of normal
- Patients must not exceed the weight and size limits of the treatment table or CT
scanner
- No mental status changes or bladder control problems that would preclude study
compliance with bladder-filling instructions
- No active inflammatory bowel disease
- No severe, active, concurrent illness, defined as any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- No history of allergy to cisplatin (cervical cancer patients)
- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for
≥ 3 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy
fields
- No prior platinum-based chemotherapy (cervical cancer patients)
- No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim
[GM-CSF], or pegfilgrastim)
- No concurrent prophylactic thrombopoietic agents
- No concurrent amifostine or other protective agents
We found this trial at
152
sites
Vineland, New Jersey 08360
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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902 Savannah Road
Lewes, Delaware 19958
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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1600 Divisadero Street
San Francisco, California 94115
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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161 North Forge Street
Akron, Ohio 44304
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
Beech Grove, Indiana 46237
(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
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St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
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44 Binney St
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 632-6364
Dana-Farber/Brigham and Women's Cancer Center Boston's Brigham and Women's Hospital (BWH) is an international leader...
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
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Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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20055 Lake Chabot Rd #130
Castro Valley, California 94546
Castro Valley, California 94546
(510) 888-0657
Valley Medical Oncology Consultants - Castro Valley Valley Medical Oncology Consultants (VMOC) has been helping...
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Sandra L. Maxwell Cancer Center The Huntsman-Intermountain Cancer Center at Valley View Medical Center in...
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Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
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Drexel Hill, Pennsylvania 19026
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Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
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Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
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Mason District Hospital Mason District Hospital is dedicated to providing superior healthcare close to home...
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Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Providence Medical Center At Providence Medical Center you will discover quality doctors, innovative technology and...
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North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
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Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Kansas City, Missouri 64154
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Kingsport, Tennessee 37662
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Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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McDonough District Hospital McDonough District Hospital is centered in Macomb, Illinois, home to Division 1...
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6780 Mayfield Rd
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
(440) 312-4569
Hillcrest Cancer Center at Hillcrest Hospital Hillcrest Hospital opened on November 23, 1968, in Mayfield...
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2160 S. First Ave.
Maywood, Illinois 60153
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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5121 South Cottonwood Street
Murray, Utah 84157
Murray, Utah 84157
(801) 507-3800
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center The Jon and Karen Huntsman...
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Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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CCOP - Bay Area Tumor Institute he Bay Area Tumor Institute Community Clinical Oncology Program...
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350 Hawthorne Ave
Oakland, California 94609
Oakland, California 94609
(510) 655-4000
Alta Bates Summit Medical Center - Summit Campus Alta Bates Summit Medical Center offers comprehensive...
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Highland General Hospital Highland Hospital is the largest campus of Alameda Health System. With 236...
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Olympia Fields, Illinois 60461
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