Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
2018年8月27日 更新者：Radiation Therapy Oncology Group
A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity (grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with conventionally delivered radiotherapy, as was utilized in the capecitabine and oxaliplatin arm of RTOG-0247 (NCT00081289).
Secondary
- To evaluate the feasibility of performing IMRT in a cooperative group setting for the treatment of rectal cancer.
- To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment in the neoadjuvant period, the adjuvant period, and overall.
- To estimate the pathologic complete response rate following neoadjuvant IMRT-based chemoradiotherapy.
- To estimate the time to treatment failure and patterns of failure.
- To correlate pre- and post-treatment levels of serum cytokines with symptoms during and pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer.
- To evaluate the rate of abdominoperineal resections.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy). Beginning on the first day of radiotherapy and continuing through completion of radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5 weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29.
- Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo resection of the rectal tumor.
- Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely resected disease and negative surgical margins receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.
研究の種類
介入
入学 (実際)
79
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Alabama
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Mobile、Alabama、アメリカ、36608
- Providence Cancer Center at Providence Hospital
-
-
California
-
Auburn、California、アメリカ、95603
- Auburn Radiation Oncology
-
Cameron Park、California、アメリカ、95682
- Radiation Oncology Centers - Cameron Park
-
Carmichael、California、アメリカ、95608
- Mercy Cancer Center at Mercy San Juan Medical Center
-
Duarte、California、アメリカ、91010-3000
- City of Hope Comprehensive Cancer Center
-
Fresno、California、アメリカ、93720
- California Cancer Center - Woodward Park Office
-
La Jolla、California、アメリカ、92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Roseville、California、アメリカ、95661
- Radiation Oncology Center - Roseville
-
Sacramento、California、アメリカ、95815
- Radiological Associates of Sacramento Medical Group, Incorporated
-
Sacramento、California、アメリカ、95819
- Mercy General Hospital
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San Diego、California、アメリカ、92161
- Veterans Affairs Medical Center - San Diego
-
Vacaville、California、アメリカ、95687
- Solano Radiation Oncology Center
-
-
Florida
-
Boca Raton、Florida、アメリカ、33486
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
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Gainesville、Florida、アメリカ、32610-0232
- University of Florida Shands Cancer Center
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Jacksonville、Florida、アメリカ、32207
- Baptist Cancer Institute - Jacksonville
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Miami、Florida、アメリカ、33176
- Baptist-South Miami Regional Cancer Program
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Orange Park、Florida、アメリカ、32073
- Integrated Community Oncology Network - Orange Park
-
Panama City、Florida、アメリカ、32401
- Bay Medical
-
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Georgia
-
Atlanta、Georgia、アメリカ、30309
- Piedmont Hospital
-
Columbus、Georgia、アメリカ、31904
- John B. Amos Cancer Center
-
Savannah、Georgia、アメリカ、31403-3089
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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-
Illinois
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Springfield、Illinois、アメリカ、62702
- Cancer Institute at St. John's Hospital
-
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Indiana
-
Anderson、Indiana、アメリカ、46016
- Saint John's Cancer Center at Saint John's Medical Center
-
Goshen、Indiana、アメリカ、46526
- Center for Cancer Care at Goshen General Hospital
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Indianapolis、Indiana、アメリカ、46260
- St. Vincent Oncology Center
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Muncie、Indiana、アメリカ、47303-3499
- Cancer Center at Ball Memorial Hospital
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Kansas
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Overland Park、Kansas、アメリカ、66209
- Menorah Medical Center
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Overland Park、Kansas、アメリカ、66213
- Saint Luke's Hospital - South
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Shawnee Mission、Kansas、アメリカ、66204
- Shawnee Mission Medical Center
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Greenebaum Cancer Center at University of Maryland Medical Center
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
Boston、Massachusetts、アメリカ、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston、Massachusetts、アメリカ、02118
- Boston University Cancer Research Center
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Boston、Massachusetts、アメリカ、02115
- Dana-Farber/Brigham and Women's Cancer Center
-
Fall River、Massachusetts、アメリカ、02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
-
-
Minnesota
-
Burnsville、Minnesota、アメリカ、55337
- Fairview Ridges Hospital
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina、Minnesota、アメリカ、55435
- Fairview Southdale Hospital
-
Fridley、Minnesota、アメリカ、55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Maplewood、Minnesota、アメリカ、55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Minneapolis、Minnesota、アメリカ、55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Robbinsdale、Minnesota、アメリカ、55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Saint Louis Park、Minnesota、アメリカ、55416
- CCOP - Metro-Minnesota
-
Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Cancer Center
-
Saint Paul、Minnesota、アメリカ、55102
- United Hospital
-
Shakopee、Minnesota、アメリカ、55379
- St. Francis Cancer Center at St. Francis Medical Center
-
Waconia、Minnesota、アメリカ、55387
- Ridgeview Medical Center
-
Woodbury、Minnesota、アメリカ、55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Mississippi
-
Pascagoula、Mississippi、アメリカ、39581
- Regional Cancer Center at Singing River Hospital
-
-
Missouri
-
Cape Girardeau、Missouri、アメリカ、63703
- Cancer Institute of Cape Girardeau, LLC
-
Kansas City、Missouri、アメリカ、64131
- CCOP - Kansas City
-
Kansas City、Missouri、アメリカ、64116
- North Kansas City Hospital
-
Kansas City、Missouri、アメリカ、64132
- Research Medical Center
-
Kansas City、Missouri、アメリカ、64108
- Truman Medical Center - Hospital Hill
-
Kansas City、Missouri、アメリカ、64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
-
Kansas City、Missouri、アメリカ、64114
- St. Joseph Medical Center
-
Kansas City、Missouri、アメリカ、64116
- Parvin Radiation Oncology
-
Lee's Summit、Missouri、アメリカ、64086
- Saint Luke's East - Lee's Summit
-
Liberty、Missouri、アメリカ、64068
- Liberty Hospital
-
Saint Joseph、Missouri、アメリカ、64506
- Heartland Regional Medical Center
-
Saint Louis、Missouri、アメリカ、63141
- Barnes-Jewish West County Hospital
-
Saint Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Peters、Missouri、アメリカ、63376
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
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Springfield、Missouri、アメリカ、65802
- CCOP - Cancer Research for the Ozarks
-
Springfield、Missouri、アメリカ、65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Omaha、Nebraska、アメリカ、68198
- Nebraska Medical Center
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Nevada
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Las Vegas、Nevada、アメリカ、89102
- University Medical Center of Southern Nevada
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Las Vegas、Nevada、アメリカ、89106
- CCOP - Nevada Cancer Research Foundation
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Reno、Nevada、アメリカ、89502
- Renown Institute for Cancer at Renown Regional Medical Center
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New Hampshire
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Keene、New Hampshire、アメリカ、03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon、New Hampshire、アメリカ、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Long Branch、New Jersey、アメリカ、07740-6395
- Monmouth Medical Center
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Marlton、New Jersey、アメリカ、08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Toms River、New Jersey、アメリカ、08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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New York
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Brooklyn、New York、アメリカ、11219
- Maimonides Cancer Center at Maimonides Medical Center
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Lake Success、New York、アメリカ、11042
- Monter Cancer Center of the North Shore-LIJ Health System
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Manhasset、New York、アメリカ、11030
- CCOP - North Shore University Hospital
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Manhasset、New York、アメリカ、11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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New Hyde Park、New York、アメリカ、11040
- Long Island Jewish Medical Center
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North Carolina
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Goldsboro、North Carolina、アメリカ、27534
- Wayne Radiation Oncology
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Goldsboro、North Carolina、アメリカ、27534
- Wayne Memorial Hospital, Incorporated
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Ohio
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Akron、Ohio、アメリカ、44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Barberton、Ohio、アメリカ、44203
- Barberton Citizens Hospital
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Cincinnati、Ohio、アメリカ、45267
- Charles M. Barrett Cancer Center at University Hospital
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Columbus、Ohio、アメリカ、43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Salem、Ohio、アメリカ、44460
- Cancer Care Center, Incorporated
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West Chester、Ohio、アメリカ、45069
- Precision Radiotherapy at University Pointe
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Wooster、Ohio、アメリカ、44691
- Cancer Treatment Center
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- Oklahoma University Cancer Institute
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Oklahoma City、Oklahoma、アメリカ、73112
- Integris Oncology Services
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Pennsylvania
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Abington、Pennsylvania、アメリカ、19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Hospital
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Dunmore、Pennsylvania、アメリカ、18512
- Northeast Radiation Oncology Center
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East Stroudsburg、Pennsylvania、アメリカ、18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Media、Pennsylvania、アメリカ、19063
- Riddle Memorial Hospital Cancer Center
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Milford、Pennsylvania、アメリカ、18337
- Upper Delaware Valley Cancer Center
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Paoli、Pennsylvania、アメリカ、19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia、Pennsylvania、アメリカ、19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia、Pennsylvania、アメリカ、19114
- Frankford Hospital Cancer Center - Torresdale Campus
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Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood、Pennsylvania、アメリカ、19096
- CCOP - Main Line Health
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Hollings Cancer Center at Medical University of South Carolina
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Tennessee
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Kingsport、Tennessee、アメリカ、37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Utah
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American Fork、Utah、アメリカ、84003
- American Fork Hospital
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Cedar City、Utah、アメリカ、84720
- Sandra L. Maxwell Cancer Center
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Murray、Utah、アメリカ、84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden、Utah、アメリカ、84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo、Utah、アメリカ、84604
- Utah Valley Regional Medical Center - Provo
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Saint George、Utah、アメリカ、84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City、Utah、アメリカ、84103
- LDS Hospital
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Salt Lake City、Utah、アメリカ、84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Saint Johnsbury、Vermont、アメリカ、05819
- Norris Cotton Cancer Center - North
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Virginia
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Charlottesville、Virginia、アメリカ、22908
- University of Virginia Cancer Center
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Norton、Virginia、アメリカ、24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Wisconsin
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Mequon、Wisconsin、アメリカ、53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin Cancer Center
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Milwaukee、Wisconsin、アメリカ、53211
- Columbia-Saint Mary's Cancer Care Center
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-
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Ontario
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London、Ontario、カナダ、N6A 4L6
- London Regional Cancer Program at London Health Sciences Centre
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)
- Located up to 12 cm from the anal verge with no extension of malignant disease into the anal canal
Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by the following assessments:
- Colonoscopy and biopsy within 56 days prior to registration
- History/physical examination (including medication history screen for contraindications) within 56 days prior to registration
- Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography(CT), MRI, or Positron-emission tomography(PET)-CT (whole body preferred) within 56 days prior to registration
- Chest x-ray (or CT) of the chest within within 56 days prior to registration to exclude distant metastases (except for patients who have had whole body PET-CT)
Transrectal ultrasound (TRUS) within 56 days prior to registration required to establish tumor stage
- TRUS not required if clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion
- No synchronous primary colon carcinoma
- No evidence of distant metastases (M1)
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Zubrod performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
- Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine clearance > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years
Exclusion criteria:
Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
- Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
- Evidence of peripheral neuropathy ≥ grade 2
- Prior allergic reaction to oxaliplatin or capecitabine
- Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
- Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
- Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection)
- Participation in any investigational drug study within 28 days of study enrollment.
- Concurrent cimetidine, amifostine, and/or depot Sandostatin
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
|
他の名前：
1650 mg/m^2/day orally 5 days/week during radiotherapy.
All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy.
The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.
Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx
Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1. Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
時間枠：From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
|
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.
|
From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
時間枠：Pretreatment
|
Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases.
The final cases enrolled were reviewed within 3 months after accrual was completed.
Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.
|
Pretreatment
|
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Number of Patients With Pathologic Complete Response
時間枠：At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
|
Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
|
At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
|
|
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
時間枠：From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
|
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 AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;
|
From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
|
|
Local-regional Failure: 4-year Rate
時間枠：From registration to four years
|
Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment.
Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment.
Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk).
Local-regional failure rates are estimated by the cumulative incidence method.
|
From registration to four years
|
|
Distant Failure: 4-year Rate
時間枠：From registration to four years
|
Distant failure is defined as the appearance of peritoneal seeding or distant metastases.
Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk).
Distant failure rates are estimated by the cumulative incidence method.
|
From registration to four years
|
|
Overall Survival: 4-year Rate
時間枠：From registration to four years
|
Overall survival time is defined as time from registration to the date of death from any cause.
Overall survival rates are estimated by the Kaplan-Meier method.
Patients last known to be alive are censored at the date of last contact.
|
From registration to four years
|
|
Disease-free Survival: 4-year Rate
時間枠：From registration to four years
|
Disease is defined as local-regional failure or distant failure.
Distant failure is defined as the appearance of peritoneal seeding or distant metastases.
Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment.
Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored).
Disease-free survival rates are estimated using the Kaplan-Meier method.
|
From registration to four years
|
|
Number of Patients Who Underwent Abdominoperineal Resection
時間枠：Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
|
All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy.
The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon.
If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.
|
Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Michael C. Garofalo, MD、University of Maryland Greenebaum Cancer Center
- スタディチェア：Adam C. Berger, MD、Sidney Kimmel Cancer Center at Thomas Jefferson University
- スタディチェア：Johanna Bendell, MD、Duke Cancer Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年4月1日
一次修了 (実際)
2010年1月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2008年2月9日
QC基準を満たした最初の提出物
2008年2月9日
最初の投稿 (見積もり)
2008年2月12日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月25日
QC基準を満たした最後の更新が送信されました
2018年8月27日
最終確認日
2018年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
大腸がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
オキサリプラチンの臨床試験
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Hospices Civils de Lyonわからない