이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2019년 2월 1일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

106

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
방사능: 강도 변조 방사선 요법
다른: 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.
의약품: 시스플라틴
방사능: 강도 변조 방사선 요법

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Patients With Grade 2+ Bowel Adverse Events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

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스폰서

Radiation Therapy Oncology Group

협력자

National Cancer Institute (NCI)
NRG Oncology

수사관

  • 연구 의자: Anuja Jhingran, MD, M.D. Anderson Cancer Center

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 3월 1일

기본 완료 (실제)

2009년 2월 1일

연구 완료 (실제)

2016년 12월 1일

연구 등록 날짜

최초 제출

2006년 5월 30일

QC 기준을 충족하는 최초 제출

2006년 5월 30일

처음 게시됨 (추정)

2006년 5월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 2월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 2월 1일

마지막으로 확인됨

2019년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RTOG-0418
  • CDR0000472905

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