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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

1 de febrero de 2019 actualizado por: Radiation Therapy Oncology Group

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

106

Fase

Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Canadá
- Ontario
  - Toronto, Ontario, Canadá, M5G 2M9
    - Princess Margaret Hospital
- Quebec
  - Montreal, Quebec, Canadá, H2W 1S6
    - McGill Cancer Centre at McGill University
Estados Unidos
- California
  - Auburn, California, Estados Unidos, 95603
    - Auburn Radiation Oncology
  - Cameron Park, California, Estados Unidos, 95682
    - Radiation Oncology Centers - Cameron Park
  - Carmichael, California, Estados Unidos, 95608
    - Mercy Cancer Center at Mercy San Juan Medical Center
  - Castro Valley, California, Estados Unidos, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, Estados Unidos, 94546
    - Eden Medical Center
  - Castro Valley, California, Estados Unidos, 94546
    - Valley Medical Oncology Consultants - Castro Valley
  - Duarte, California, Estados Unidos, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fremont, California, Estados Unidos, 94538
    - Valley Medical Oncology
  - La Jolla, California, Estados Unidos, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Oakland, California, Estados Unidos, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, Estados Unidos, 94602
    - Highland General Hospital
  - Oakland, California, Estados Unidos, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, Estados Unidos, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, Estados Unidos, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, Estados Unidos, 94609
    - Tom K Lee, Incorporated
  - Pleasanton, California, Estados Unidos, 94588
    - Valley Care Medical Center
  - Pleasanton, California, Estados Unidos, 94588
    - Valley Medical Oncology Consultants - Pleasanton
  - Roseville, California, Estados Unidos, 95661
    - Radiation Oncology Center - Roseville
  - Sacramento, California, Estados Unidos, 95815
    - Radiological Associates of Sacramento Medical Group, Incorporated
  - Sacramento, California, Estados Unidos, 95819
    - Mercy General Hospital
  - San Diego, California, Estados Unidos, 92161
    - Veterans Affairs Medical Center - San Diego
  - San Francisco, California, Estados Unidos, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Pablo, California, Estados Unidos, 94806
    - Doctors Medical Center - San Pablo Campus
  - Vacaville, California, Estados Unidos, 95687
    - Solano Radiation Oncology Center
- Delaware
  - Lewes, Delaware, Estados Unidos, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, Estados Unidos, 19713
    - CCOP - Christiana Care Health Services
- Florida
  - Jacksonville, Florida, Estados Unidos, 32224
    - Mayo Clinic - Jacksonville
  - Panama City, Florida, Estados Unidos, 32401
    - Bay Medical
- Illinois
  - Bloomington, Illinois, Estados Unidos, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Estados Unidos, 61520
    - Graham Hospital
  - Carthage, Illinois, Estados Unidos, 62321
    - Memorial Hospital
  - Chicago, Illinois, Estados Unidos, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Elk Grove Village, Illinois, Estados Unidos, 60007
    - Alexian Brothers Radiation Oncology
  - Eureka, Illinois, Estados Unidos, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Estados Unidos, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Estados Unidos, 61401
    - Galesburg Clinic, PC
  - Galesburg, Illinois, Estados Unidos, 61401
    - InterCommunity Cancer Center of Western Illinois
  - Havana, Illinois, Estados Unidos, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Estados Unidos, 61747
    - Hopedale Medical Complex
  - Macomb, Illinois, Estados Unidos, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, Estados Unidos, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Normal, Illinois, Estados Unidos, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Estados Unidos, 61761
    - Community Cancer Center
  - Olympia Fields, Illinois, Estados Unidos, 60461
    - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
  - Ottawa, Illinois, Estados Unidos, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Estados Unidos, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Estados Unidos, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Estados Unidos, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Estados Unidos, 61614
    - Proctor Hospital
  - Peoria, Illinois, Estados Unidos, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Estados Unidos, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peoria, Illinois, Estados Unidos, 61615-7827
    - OSF St. Francis Medical Center
  - Peru, Illinois, Estados Unidos, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Estados Unidos, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Estados Unidos, 61362
    - St. Margaret's Hospital
  - Spring Valley, Illinois, Estados Unidos, 61362
    - Valley Cancer Center
  - Springfield, Illinois, Estados Unidos, 62702
    - Cancer Institute at St. John's Hospital
- Indiana
  - Beech Grove, Indiana, Estados Unidos, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Hammond, Indiana, Estados Unidos, 46320
    - Oncology Center at Saint Margaret Mercy Healthcare Center
  - Richmond, Indiana, Estados Unidos, 47374
    - Reid Hospital & Health Care Services
- Iowa
  - Iowa City, Iowa, Estados Unidos, 52242-1002
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Kansas City, Kansas, Estados Unidos, 66112
    - Providence Medical Center
  - Lawrence, Kansas, Estados Unidos, 66044
    - Lawrence Memorial Hospital
  - Overland Park, Kansas, Estados Unidos, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, Estados Unidos, 66210
    - Johnson County Radiation Therapy
  - Shawnee Mission, Kansas, Estados Unidos, 66204
    - Shawnee Mission Medical Center
- Maine
  - Lewiston, Maine, Estados Unidos, 04240
    - Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- Maryland
  - Elkton, Maryland, Estados Unidos, 21921
    - Union Hospital Cancer Program at Union Hospital
- Massachusetts
  - Boston, Massachusetts, Estados Unidos, 02115
    - Dana-Farber/Brigham and Women's Cancer Center
  - Quincy, Massachusetts, Estados Unidos, 02169
    - South Suburban Oncology Center
  - South Weymouth, Massachusetts, Estados Unidos, 02190
    - South Shore Hospital
- Michigan
  - Ann Arbor, Michigan, Estados Unidos, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Estados Unidos, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Kalamazoo, Michigan, Estados Unidos, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, Estados Unidos, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, Estados Unidos, 49007-3731
    - West Michigan Cancer Center
- Minnesota
  - Rochester, Minnesota, Estados Unidos, 55905
    - Mayo Clinic Cancer Center
- Missouri
  - Cape Girardeau, Missouri, Estados Unidos, 63703
    - Cancer Institute of Cape Girardeau, LLC
  - Independence, Missouri, Estados Unidos, 64050
    - Independence Regional Health Center
  - Kansas City, Missouri, Estados Unidos, 64131
    - CCOP - Kansas City
  - Kansas City, Missouri, Estados Unidos, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, Estados Unidos, 64132
    - Research Medical Center
  - Kansas City, Missouri, Estados Unidos, 64108
    - Truman Medical Center - Hospital Hill
  - Kansas City, Missouri, Estados Unidos, 64111
    - Saint Luke's Cancer Institute at Saint Luke's Hospital
  - Kansas City, Missouri, Estados Unidos, 64114
    - St. Joseph Medical Center
  - Kansas City, Missouri, Estados Unidos, 64116
    - Parvin Radiation Oncology
  - Kansas City, Missouri, Estados Unidos, 64114
    - Kansas City Cancer Center at St. Joseph's Medical Mall
  - Kansas City, Missouri, Estados Unidos, 64154
    - Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
  - Saint Joseph, Missouri, Estados Unidos, 64506
    - Heartland Regional Medical Center
  - Springfield, Missouri, Estados Unidos, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Estados Unidos, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Estados Unidos, 65807
    - Hulston Cancer Center at Cox Medical Center South
- New Jersey
  - Camden, New Jersey, Estados Unidos, 08103
    - Cancer Institute of New Jersey at Cooper University Hospital - Camden
  - Long Branch, New Jersey, Estados Unidos, 07740-6395
    - Monmouth Medical Center
  - New Brunswick, New Jersey, Estados Unidos, 08903
    - Saint Peter's University Hospital
  - Vineland, New Jersey, Estados Unidos, 08360
    - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
  - Voorhees, New Jersey, Estados Unidos, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
- New Mexico
  - Albuquerque, New Mexico, Estados Unidos, 87131-5636
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, Estados Unidos, 87102
    - Lovelace Medical Center - Downtown
  - Albuquerque, New Mexico, Estados Unidos, 87109
    - Radiation Oncology Associates, PA
  - Santa Fe, New Mexico, Estados Unidos, 87505
    - Cancer Institute of New Mexico
- New York
  - Buffalo, New York, Estados Unidos, 14263-0001
    - Roswell Park Cancer Institute
  - New York, New York, Estados Unidos, 10025
    - St. Luke's - Roosevelt Hospital Center - St.Luke's Division
  - New York, New York, Estados Unidos, 10003-3803
    - Beth Israel Medical Center - Petrie Division
- North Carolina
  - Charlotte, North Carolina, Estados Unidos, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
- Ohio
  - Akron, Ohio, Estados Unidos, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Akron, Ohio, Estados Unidos, 44309-2090
    - Summa Center for Cancer Care at Akron City Hospital
  - Cleveland, Ohio, Estados Unidos, 44106-5065
    - Case Comprehensive Cancer Center
  - Cleveland, Ohio, Estados Unidos, 44112
    - Huron Hospital Cancer Care Center
  - Cleveland, Ohio, Estados Unidos, 44119
    - Euclid Hospital
  - Dayton, Ohio, Estados Unidos, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Estados Unidos, 45405
    - Grandview Hospital
  - Dayton, Ohio, Estados Unidos, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Estados Unidos, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Estados Unidos, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Estados Unidos, 45429
    - CCOP - Dayton
  - Findlay, Ohio, Estados Unidos, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, Estados Unidos, 45005-1066
    - Middletown Regional Hospital
  - Kettering, Ohio, Estados Unidos, 45429
    - Charles F. Kettering Memorial Hospital
  - Mayfield Heights, Ohio, Estados Unidos, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Salem, Ohio, Estados Unidos, 44460
    - Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
  - Troy, Ohio, Estados Unidos, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Warrensville Heights, Ohio, Estados Unidos, 44122
    - South Pointe Hospital Cancer Care Center
  - Wilmington, Ohio, Estados Unidos, 45177
    - Clinton Memorial Hospital
  - Wooster, Ohio, Estados Unidos, 44691
    - Cancer Treatment Center
  - Xenia, Ohio, Estados Unidos, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Pennsylvania
  - Bryn Mawr, Pennsylvania, Estados Unidos, 19010
    - Bryn Mawr Hospital
  - Drexel Hill, Pennsylvania, Estados Unidos, 19026
    - Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  - Paoli, Pennsylvania, Estados Unidos, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Wynnewood, Pennsylvania, Estados Unidos, 19096
    - Lankenau Cancer Center at Lankenau Hospital
  - Wynnewood, Pennsylvania, Estados Unidos, 19096
    - CCOP - Main Line Health
- South Dakota
  - Rapid City, South Dakota, Estados Unidos, 57701
    - Rapid City Regional Hospital
- Tennessee
  - Kingsport, Tennessee, Estados Unidos, 37662
    - Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Texas
  - Houston, Texas, Estados Unidos, 77030-4009
    - M. D. Anderson Cancer Center at University of Texas
- Utah
  - American Fork, Utah, Estados Unidos, 84003
    - American Fork Hospital
  - Cedar City, Utah, Estados Unidos, 84720
    - Sandra L. Maxwell Cancer Center
  - Murray, Utah, Estados Unidos, 84157
    - Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  - Ogden, Utah, Estados Unidos, 84403
    - Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  - Provo, Utah, Estados Unidos, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, Estados Unidos, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, Estados Unidos, 84112
    - Huntsman Cancer Institute at University of Utah
  - Salt Lake City, Utah, Estados Unidos, 84103
    - LDS Hospital
  - Salt Lake City, Utah, Estados Unidos, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Burlington, Vermont, Estados Unidos, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Norton, Virginia, Estados Unidos, 24273
    - Southwest Virginia Regional Cancer Center at Wellmonth Health
- Washington
  - Seattle, Washington, Estados Unidos, 98101
    - CCOP - Virginia Mason Research Center
- Wisconsin
  - La Crosse, Wisconsin, Estados Unidos, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Estados Unidos, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Mequon, Wisconsin, Estados Unidos, 53097
    - Columbia Saint Mary's Hospital - Ozaukee
  - Milwaukee, Wisconsin, Estados Unidos, 53211
    - Columbia-Saint Mary's Cancer Care Center
  - Wausau, Wisconsin, Estados Unidos, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: No aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Otro: Endometrial Cancer: IMRT Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.	Radiación: radioterapia de intensidad modulada
Otro: 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.	Droga: cisplatino Radiación: radioterapia de intensidad modulada

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) Periodo de tiempo: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.	Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%. For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%.	IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Percentage of Patients With Grade 2+ Bowel Adverse Events Periodo de tiempo: From the start of treatment to 90 days.	Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.	From the start of treatment to 90 days.
Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events Periodo de tiempo: From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.	Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.	From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events Periodo de tiempo: From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.	Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.	From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant Periodo de tiempo: From start to end of chemotherapy, approximately five weeks from registration.	Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.	From start to end of chemotherapy, approximately five weeks from registration.
Rate of Local-regional Failure at Five Years Periodo de tiempo: From registration to five years.	Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.	From registration to five years.
Rate of Distant Metastases at Five Years Periodo de tiempo: From registration to five years	Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.	From registration to five years
Rate of Disease-free Survival at Five Years Periodo de tiempo: From registration five years	Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.	From registration five years
Rate of Overall Survival at Five Years Periodo de tiempo: From randomization to five years	Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.	From randomization to five years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Radiation Therapy Oncology Group

Colaboradores

National Cancer Institute (NCI)

NRG Oncology

Investigadores

Silla de estudio: Anuja Jhingran, MD, M.D. Anderson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2006

Finalización primaria (Actual)

1 de febrero de 2009

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

30 de mayo de 2006

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2006

Publicado por primera vez (Estimar)

31 de mayo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de febrero de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

1 de febrero de 2019

Última verificación

1 de febrero de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

RTOG-0418
CDR0000472905

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Cáncer de cuello uterino

Stanford University

Terminado

Férula de clavícula para la reducción del dolor después de la cirugía cervicotorácica posterior

Cirugía Cervical Posterior | Fusión cervical posterior | Laminectomía cervical posterior | Laminoplastia Cervical Posterior

Estados Unidos
Gazi University

Reclutamiento

Traducción, Adaptación Cultural, Confiabilidad y Validez de la Versión Turca de la Escala de Impacto de Radiculopatía Cervical

Radiculopatía cervical | Dolor radicular cervical | Radiculitis cervical | Síndrome de la raíz cervical

Pavo
Valérie Schuermans

Reclutamiento

Estudio de Costo-Efectividad de la Artroplastia Cervical (CACES) (CACES)

Enfermedad del disco cervical | Fusión cervical | Fusión de columna | Espondilosis cervical | Hernia de disco cervical | Mielopatía cervical | Degeneración del disco cervical | Radiculopatía Cervical | Mielopatía Compresiva | Radiculopatía, Región Cervical | Radiculopatía; en espondilosis | Radiculopatía; en... y otras condiciones

Países Bajos
Blaz Barun

Reclutamiento

Efectos de una aplicación móvil sobre la adherencia al ejercicio diario y la recuperación después de una lesión por latigazo cervical

Lesión por latigazo cervical de la columna cervical

Croacia
University of Iceland
Landspitali University Hospital; Reykjavik University; Empowered Health

Activo, no reclutando

Rehabilitación de trastornos asociados al latigazo cervical

Lesión por latigazo cervical de la columna cervical

Islandia
NuVasive

Inscripción por invitación

Estudio del sistema NuVasive® ACP

Radiculopatía cervical | Enfermedad del disco cervical | Enfermedad de la columna cervical | Mielopatía cervical | Espondilosis cervical | Hernia de disco cervical | Estenosis cervical

Estados Unidos
Istanbul Medipol University Hospital

Terminado

Efecto de la técnica de liberación miofascial en pacientes con radiculopatía cervical unilateral

Dolor | Radiculopatía cervical | Enfermedad del disco cervical | Hernia de disco cervical | Dolor radicular cervical | Cervical; Hernia

Pavo
University of Michigan
Washington University School of Medicine; LFR International

Terminado

Tres intervenciones educativas para la inmovilización de la columna cervical prehospitalaria por parte de legos

Lesión de la vértebra cervical | Fractura de vértebra cervical

Estados Unidos
Western Galilee Hospital-Nahariya

Reclutamiento

Comparación de métodos para la inserción de catéteres con balón: vista guiada (espéculo) versus guía manual en el examen cervical

Maduración Cervical

Israel
Imperial College Healthcare NHS Trust
Imperial College London; The Wellington Hospital, London

Terminado

Medidas de angulación de la columna C

Columna cervical

Reino Unido

Ensayos clínicos sobre cisplatino

Korea Cancer Center Hospital

Terminado

Quimiorradiación simultánea con cisplatino cada 3 semanas en cáncer de cuello uterino avanzado

NEOPLASIAS CERVICALES

Corea, república de
Third Military Medical University

Desconocido

Aplicación de la detección de células tumorales circulantes en el tratamiento preciso del adenocarcinoma de pulmón en estadio temprano (CTCs detection)

Tratamiento | Diagnostica Enfermedades | Adenocarcinoma de pulmón, estadio I | Células tumorales circulantes

Porcelana

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

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma

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Ensayos clínicos sobre Cáncer de cuello uterino

Ensayos clínicos sobre cisplatino

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