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 febbraio 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
106
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
Quebec
-
Montreal, Quebec, Canada, H2W 1S6
- McGill Cancer Centre at McGill University
-
-
-
-
California
-
Auburn, California, Stati Uniti, 95603
- Auburn Radiation Oncology
-
Cameron Park, California, Stati Uniti, 95682
- Radiation Oncology Centers - Cameron Park
-
Carmichael, California, Stati Uniti, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
-
Castro Valley, California, Stati Uniti, 94546
- East Bay Radiation Oncology Center
-
Castro Valley, California, Stati Uniti, 94546
- Eden Medical Center
-
Castro Valley, California, Stati Uniti, 94546
- Valley Medical Oncology Consultants - Castro Valley
-
Duarte, California, Stati Uniti, 91010-3000
- City of Hope Comprehensive Cancer Center
-
Fremont, California, Stati Uniti, 94538
- Valley Medical Oncology
-
La Jolla, California, Stati Uniti, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
-
Oakland, California, Stati Uniti, 94609
- Alta Bates Summit Medical Center - Summit Campus
-
Oakland, California, Stati Uniti, 94602
- Highland General Hospital
-
Oakland, California, Stati Uniti, 94609
- Larry G Strieff MD Medical Corporation
-
Oakland, California, Stati Uniti, 94609
- CCOP - Bay Area Tumor Institute
-
Oakland, California, Stati Uniti, 94609
- Bay Area Breast Surgeons, Incorporated
-
Oakland, California, Stati Uniti, 94609
- Tom K Lee, Incorporated
-
Pleasanton, California, Stati Uniti, 94588
- Valley Care Medical Center
-
Pleasanton, California, Stati Uniti, 94588
- Valley Medical Oncology Consultants - Pleasanton
-
Roseville, California, Stati Uniti, 95661
- Radiation Oncology Center - Roseville
-
Sacramento, California, Stati Uniti, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
-
Sacramento, California, Stati Uniti, 95819
- Mercy General Hospital
-
San Diego, California, Stati Uniti, 92161
- Veterans Affairs Medical Center - San Diego
-
San Francisco, California, Stati Uniti, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
-
San Pablo, California, Stati Uniti, 94806
- Doctors Medical Center - San Pablo Campus
-
Vacaville, California, Stati Uniti, 95687
- Solano Radiation Oncology Center
-
-
Delaware
-
Lewes, Delaware, Stati Uniti, 19958
- Tunnell Cancer Center at Beebe Medical Center
-
Newark, Delaware, Stati Uniti, 19713
- CCOP - Christiana Care Health Services
-
-
Florida
-
Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic - Jacksonville
-
Panama City, Florida, Stati Uniti, 32401
- Bay Medical
-
-
Illinois
-
Bloomington, Illinois, Stati Uniti, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Stati Uniti, 61520
- Graham Hospital
-
Carthage, Illinois, Stati Uniti, 62321
- Memorial Hospital
-
Chicago, Illinois, Stati Uniti, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
Elk Grove Village, Illinois, Stati Uniti, 60007
- Alexian Brothers Radiation Oncology
-
Eureka, Illinois, Stati Uniti, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Clinic, PC
-
Galesburg, Illinois, Stati Uniti, 61401
- InterCommunity Cancer Center of Western Illinois
-
Havana, Illinois, Stati Uniti, 62644
- Mason District Hospital
-
Hopedale, Illinois, Stati Uniti, 61747
- Hopedale Medical Complex
-
Macomb, Illinois, Stati Uniti, 61455
- Mcdonough District Hospital
-
Maywood, Illinois, Stati Uniti, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
-
Normal, Illinois, Stati Uniti, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Stati Uniti, 61761
- Community Cancer Center
-
Olympia Fields, Illinois, Stati Uniti, 60461
- Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
-
Ottawa, Illinois, Stati Uniti, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Stati Uniti, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, Stati Uniti, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Stati Uniti, 61614
- Proctor Hospital
-
Peoria, Illinois, Stati Uniti, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Stati Uniti, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peoria, Illinois, Stati Uniti, 61615-7827
- OSF St. Francis Medical Center
-
Peru, Illinois, Stati Uniti, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Stati Uniti, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, Stati Uniti, 61362
- St. Margaret's Hospital
-
Spring Valley, Illinois, Stati Uniti, 61362
- Valley Cancer Center
-
Springfield, Illinois, Stati Uniti, 62702
- Cancer Institute at St. John's Hospital
-
-
Indiana
-
Beech Grove, Indiana, Stati Uniti, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
-
Hammond, Indiana, Stati Uniti, 46320
- Oncology Center at Saint Margaret Mercy Healthcare Center
-
Richmond, Indiana, Stati Uniti, 47374
- Reid Hospital & Health Care Services
-
-
Iowa
-
Iowa City, Iowa, Stati Uniti, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Kansas
-
Kansas City, Kansas, Stati Uniti, 66112
- Providence Medical Center
-
Lawrence, Kansas, Stati Uniti, 66044
- Lawrence Memorial Hospital
-
Overland Park, Kansas, Stati Uniti, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Stati Uniti, 66210
- Johnson County Radiation Therapy
-
Shawnee Mission, Kansas, Stati Uniti, 66204
- Shawnee Mission Medical Center
-
-
Maine
-
Lewiston, Maine, Stati Uniti, 04240
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
-
-
Maryland
-
Elkton, Maryland, Stati Uniti, 21921
- Union Hospital Cancer Program at Union Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber/Brigham and Women's Cancer Center
-
Quincy, Massachusetts, Stati Uniti, 02169
- South Suburban Oncology Center
-
South Weymouth, Massachusetts, Stati Uniti, 02190
- South Shore Hospital
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109-0942
- University Of Michigan Comprehensive Cancer Center
-
Detroit, Michigan, Stati Uniti, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
-
Kalamazoo, Michigan, Stati Uniti, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Stati Uniti, 49001
- Borgess Medical Center
-
Kalamazoo, Michigan, Stati Uniti, 49007-3731
- West Michigan Cancer Center
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
-
-
Missouri
-
Cape Girardeau, Missouri, Stati Uniti, 63703
- Cancer Institute of Cape Girardeau, LLC
-
Independence, Missouri, Stati Uniti, 64050
- Independence Regional Health Center
-
Kansas City, Missouri, Stati Uniti, 64131
- CCOP - Kansas City
-
Kansas City, Missouri, Stati Uniti, 64116
- North Kansas City Hospital
-
Kansas City, Missouri, Stati Uniti, 64132
- Research Medical Center
-
Kansas City, Missouri, Stati Uniti, 64108
- Truman Medical Center - Hospital Hill
-
Kansas City, Missouri, Stati Uniti, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
-
Kansas City, Missouri, Stati Uniti, 64114
- St. Joseph Medical Center
-
Kansas City, Missouri, Stati Uniti, 64116
- Parvin Radiation Oncology
-
Kansas City, Missouri, Stati Uniti, 64114
- Kansas City Cancer Center at St. Joseph's Medical Mall
-
Kansas City, Missouri, Stati Uniti, 64154
- Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
-
Saint Joseph, Missouri, Stati Uniti, 64506
- Heartland Regional Medical Center
-
Springfield, Missouri, Stati Uniti, 65802
- CCOP - Cancer Research for the Ozarks
-
Springfield, Missouri, Stati Uniti, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, Stati Uniti, 65807
- Hulston Cancer Center at Cox Medical Center South
-
-
New Jersey
-
Camden, New Jersey, Stati Uniti, 08103
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
-
Long Branch, New Jersey, Stati Uniti, 07740-6395
- Monmouth Medical Center
-
New Brunswick, New Jersey, Stati Uniti, 08903
- Saint Peter's University Hospital
-
Vineland, New Jersey, Stati Uniti, 08360
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
-
Voorhees, New Jersey, Stati Uniti, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Stati Uniti, 87131-5636
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Stati Uniti, 87102
- Lovelace Medical Center - Downtown
-
Albuquerque, New Mexico, Stati Uniti, 87109
- Radiation Oncology Associates, PA
-
Santa Fe, New Mexico, Stati Uniti, 87505
- Cancer Institute of New Mexico
-
-
New York
-
Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
-
New York, New York, Stati Uniti, 10025
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
-
New York, New York, Stati Uniti, 10003-3803
- Beth Israel Medical Center - Petrie Division
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
-
-
Ohio
-
Akron, Ohio, Stati Uniti, 44307
- McDowell Cancer Center at Akron General Medical Center
-
Akron, Ohio, Stati Uniti, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
-
Cleveland, Ohio, Stati Uniti, 44106-5065
- Case Comprehensive Cancer Center
-
Cleveland, Ohio, Stati Uniti, 44112
- Huron Hospital Cancer Care Center
-
Cleveland, Ohio, Stati Uniti, 44119
- Euclid Hospital
-
Dayton, Ohio, Stati Uniti, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Stati Uniti, 45405
- Grandview Hospital
-
Dayton, Ohio, Stati Uniti, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Stati Uniti, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Stati Uniti, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Stati Uniti, 45429
- CCOP - Dayton
-
Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, Stati Uniti, 45005-1066
- Middletown Regional Hospital
-
Kettering, Ohio, Stati Uniti, 45429
- Charles F. Kettering Memorial Hospital
-
Mayfield Heights, Ohio, Stati Uniti, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
-
Salem, Ohio, Stati Uniti, 44460
- Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
-
Troy, Ohio, Stati Uniti, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Warrensville Heights, Ohio, Stati Uniti, 44122
- South Pointe Hospital Cancer Care Center
-
Wilmington, Ohio, Stati Uniti, 45177
- Clinton Memorial Hospital
-
Wooster, Ohio, Stati Uniti, 44691
- Cancer Treatment Center
-
Xenia, Ohio, Stati Uniti, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, Stati Uniti, 19010
- Bryn Mawr Hospital
-
Drexel Hill, Pennsylvania, Stati Uniti, 19026
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
-
Paoli, Pennsylvania, Stati Uniti, 19301-1792
- Cancer Center of Paoli Memorial Hospital
-
Wynnewood, Pennsylvania, Stati Uniti, 19096
- Lankenau Cancer Center at Lankenau Hospital
-
Wynnewood, Pennsylvania, Stati Uniti, 19096
- CCOP - Main Line Health
-
-
South Dakota
-
Rapid City, South Dakota, Stati Uniti, 57701
- Rapid City Regional Hospital
-
-
Tennessee
-
Kingsport, Tennessee, Stati Uniti, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
-
Utah
-
American Fork, Utah, Stati Uniti, 84003
- American Fork Hospital
-
Cedar City, Utah, Stati Uniti, 84720
- Sandra L. Maxwell Cancer Center
-
Murray, Utah, Stati Uniti, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
-
Ogden, Utah, Stati Uniti, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
-
Provo, Utah, Stati Uniti, 84604
- Utah Valley Regional Medical Center - Provo
-
Saint George, Utah, Stati Uniti, 84770
- Dixie Regional Medical Center - East Campus
-
Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute at University of Utah
-
Salt Lake City, Utah, Stati Uniti, 84103
- LDS Hospital
-
Salt Lake City, Utah, Stati Uniti, 84106
- Utah Cancer Specialists at UCS Cancer Center
-
-
Vermont
-
Burlington, Vermont, Stati Uniti, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
-
Virginia
-
Norton, Virginia, Stati Uniti, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98101
- CCOP - Virginia Mason Research Center
-
-
Wisconsin
-
La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Stati Uniti, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
Mequon, Wisconsin, Stati Uniti, 53097
- Columbia Saint Mary's Hospital - Ozaukee
-
Milwaukee, Wisconsin, Stati Uniti, 53211
- Columbia-Saint Mary's Cancer Care Center
-
Wausau, Wisconsin, Stati Uniti, 54401
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Endometrial Cancer: IMRT
Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
|
|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Patients With Grade 2+ Bowel Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Anuja Jhingran, MD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2006
Completamento primario (Effettivo)
1 febbraio 2009
Completamento dello studio (Effettivo)
1 dicembre 2016
Date di iscrizione allo studio
Primo inviato
30 maggio 2006
Primo inviato che soddisfa i criteri di controllo qualità
30 maggio 2006
Primo Inserito (Stima)
31 maggio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 febbraio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 febbraio 2019
Ultimo verificato
1 febbraio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- carcinoma a cellule squamose del collo dell'utero
- carcinoma della cervice in stadio IIB
- carcinoma della cervice in stadio IB
- carcinoma della cervice allo stadio IIA
- adenocarcinoma cervicale
- carcinoma a cellule adenosquamose cervicali
- carcinoma endometriale in stadio III
- Carcinoma endometriale in stadio II
- adenocarcinoma endometriale
- carcinoma a cellule adenosquamose dell'endometrio
- Carcinoma endometriale stadio I
- adenoacantoma endometriale
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RTOG-0418
- CDR0000472905
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .