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

NCT ID: NCT00331760

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Cervical Cancer; Endometrial Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endometrial Cancer: IMRT

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.

Group Type: OTHER

intensity-modulated radiation therapy

Intervention Type: RADIATION

Cervical Cancer: IMRT + Chemotherapy (cisplatin)

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m\^2 for five weeks.

Group Type: OTHER

cisplatin

Intervention Type: DRUG

intensity-modulated radiation therapy

Intervention Type: RADIATION

Interventions

cisplatin

Intervention Type: DRUG

intensity-modulated radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anuja Jhingran, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

Auburn Radiation Oncology

Auburn, California, United States

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

East Bay Radiation Oncology Center

Castro Valley, California, United States

Eden Medical Center

Castro Valley, California, United States

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Valley Medical Oncology

Fremont, California, United States

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Highland General Hospital

Oakland, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Breast Surgeons, Incorporated

Oakland, California, United States

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Tom K Lee, Incorporated

Oakland, California, United States

Valley Care Medical Center

Pleasanton, California, United States

Valley Medical Oncology Consultants - Pleasanton

Pleasanton, California, United States

Radiation Oncology Center - Roseville

Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

Veterans Affairs Medical Center - San Diego

San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Solano Radiation Oncology Center

Vacaville, California, United States

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Bay Medical

Panama City, Florida, United States

St. Joseph Medical Center

Bloomington, Illinois, United States

Graham Hospital

Canton, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Alexian Brothers Radiation Oncology

Elk Grove Village, Illinois, United States

Eureka Community Hospital

Eureka, Illinois, United States

Galesburg Clinic, PC

Galesburg, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hopedale Medical Complex

Hopedale, Illinois, United States

McDonough District Hospital

Macomb, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

BroMenn Regional Medical Center

Normal, Illinois, United States

Community Cancer Center

Normal, Illinois, United States

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

Olympia Fields, Illinois, United States

Community Hospital of Ottawa

Ottawa, Illinois, United States

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Illinois Valley Community Hospital

Peru, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

St. Margaret's Hospital

Spring Valley, Illinois, United States

Valley Cancer Center

Spring Valley, Illinois, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Oncology Center at Saint Margaret Mercy Healthcare Center

Hammond, Indiana, United States

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Providence Medical Center

Kansas City, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Menorah Medical Center

Overland Park, Kansas, United States

Johnson County Radiation Therapy

Overland Park, Kansas, United States

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Central Maine Comprehensive Cancer Center at Central Maine Medical Center

Lewiston, Maine, United States

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, United States

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

South Suburban Oncology Center

Quincy, Massachusetts, United States

South Shore Hospital

South Weymouth, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, United States

Independence Regional Health Center

Independence, Missouri, United States

Truman Medical Center - Hospital Hill

Kansas City, Missouri, United States

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, United States

Kansas City Cancer Center at St. Joseph's Medical Mall

Kansas City, Missouri, United States

St. Joseph Medical Center

Kansas City, Missouri, United States

North Kansas City Hospital

Kansas City, Missouri, United States

Parvin Radiation Oncology

Kansas City, Missouri, United States

CCOP - Kansas City

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center

Kansas City, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

St. John's Regional Health Center

Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Camden, New Jersey, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

Vineland, New Jersey, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Lovelace Medical Center - Downtown

Albuquerque, New Mexico, United States

Radiation Oncology Associates, PA

Albuquerque, New Mexico, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Cancer Institute of New Mexico

Santa Fe, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Beth Israel Medical Center - Petrie Division

New York, New York, United States

St. Luke's - Roosevelt Hospital Center - St.Luke's Division

New York, New York, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, United States

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Huron Hospital Cancer Care Center

Cleveland, Ohio, United States

Euclid Hospital

Cleveland, Ohio, United States

Grandview Hospital

Dayton, Ohio, United States

Good Samaritan Hospital

Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Samaritan North Cancer Care Center

Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, United States

CCOP - Dayton

Dayton, Ohio, United States

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Middletown Regional Hospital

Franklin, Ohio, United States

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, United States

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

South Pointe Hospital Cancer Care Center

Warrensville Heights, Ohio, United States

Clinton Memorial Hospital

Wilmington, Ohio, United States

Cancer Treatment Center

Wooster, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, United States

CCOP - Main Line Health

Wynnewood, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

American Fork Hospital

American Fork, Utah, United States

Sandra L. Maxwell Cancer Center

Cedar City, Utah, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Southwest Virginia Regional Cancer Center at Wellmonth Health

Norton, Virginia, United States

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, United States

Columbia-Saint Mary's Cancer Care Center

Milwaukee, Wisconsin, United States

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

McGill Cancer Centre at McGill University

Montreal, Quebec, Canada

Countries

United States; Canada

References

Jhingran A, Winter K, Portelance L, Miller B, Salehpour M, Gaur R, Souhami L, Small W Jr, Berk L, Gaffney D. A phase II study of intensity modulated radiation therapy to the pelvis for postoperative patients with endometrial carcinoma: radiation therapy oncology group trial 0418. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):e23-8. doi: 10.1016/j.ijrobp.2012.02.044. Epub 2012 Apr 28.

Reference Type: RESULT

PMID: 22543211 (View on PubMed)

Other Identifiers

CDR0000472905

Identifier Type: -

Identifier Source: secondary_id

RTOG-0418

Identifier Type: -

Identifier Source: org_study_id