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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. Februar 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

106

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
Strahlung: Intensitätsmodulierte Strahlentherapie
Sonstiges: 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.
Arzneimittel: Cisplatin
Strahlung: Intensitätsmodulierte Strahlentherapie

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Patients With Grade 2+ Bowel Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Radiation Therapy Oncology Group

Mitarbeiter

National Cancer Institute (NCI)
NRG Oncology

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2006

Primärer Abschluss (Tatsächlich)

1. Februar 2009

Studienabschluss (Tatsächlich)

1. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

30. Mai 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Mai 2006

Zuerst gepostet (Schätzen)

31. Mai 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Februar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Februar 2019

Zuletzt verifiziert

1. Februar 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RTOG-0418
  • CDR0000472905

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