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Spots Global Cancer Trial Database for Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

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Trial Identification

Brief Title: Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Official Title: 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

Study ID: NCT00613080

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Providence Cancer Center at Providence Hospital, Mobile, Alabama, United States

Auburn Radiation Oncology, Auburn, California, United States

Radiation Oncology Centers - Cameron Park, Cameron Park, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

California Cancer Center - Woodward Park Office, Fresno, California, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

Radiation Oncology Center - Roseville, Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States

Mercy General Hospital, Sacramento, California, United States

Veterans Affairs Medical Center - San Diego, San Diego, California, United States

Solano Radiation Oncology Center, Vacaville, California, United States

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus, Boca Raton, Florida, United States

University of Florida Shands Cancer Center, Gainesville, Florida, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida, United States

Integrated Community Oncology Network - Orange Park, Orange Park, Florida, United States

Bay Medical, Panama City, Florida, United States

Piedmont Hospital, Atlanta, Georgia, United States

John B. Amos Cancer Center, Columbus, Georgia, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States

Cancer Institute at St. John's Hospital, Springfield, Illinois, United States

Saint John's Cancer Center at Saint John's Medical Center, Anderson, Indiana, United States

Center for Cancer Care at Goshen General Hospital, Goshen, Indiana, United States

St. Vincent Oncology Center, Indianapolis, Indiana, United States

Cancer Center at Ball Memorial Hospital, Muncie, Indiana, United States

Menorah Medical Center, Overland Park, Kansas, United States

Saint Luke's Hospital - South, Overland Park, Kansas, United States

Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

Boston University Cancer Research Center, Boston, Massachusetts, United States

Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States

Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States

Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States

Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, United States

Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States

Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri, United States

St. Joseph Medical Center, Kansas City, Missouri, United States

North Kansas City Hospital, Kansas City, Missouri, United States

Parvin Radiation Oncology, Kansas City, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

Research Medical Center, Kansas City, Missouri, United States

Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States

Liberty Hospital, Liberty, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States

Barnes-Jewish West County Hospital, Saint Louis, Missouri, United States

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters, Saint Peters, Missouri, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States

Nebraska Medical Center, Omaha, Nebraska, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Renown Institute for Cancer at Renown Regional Medical Center, Reno, Nevada, United States

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene, New Hampshire, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Monmouth Medical Center, Long Branch, New Jersey, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States

J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River, New Jersey, United States

Maimonides Cancer Center at Maimonides Medical Center, Brooklyn, New York, United States

Monter Cancer Center of the North Shore-LIJ Health System, Lake Success, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset, New York, United States

Long Island Jewish Medical Center, New Hyde Park, New York, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Wayne Radiation Oncology, Goldsboro, North Carolina, United States

Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States

Barberton Citizens Hospital, Barberton, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

Cancer Care Center, Incorporated, Salem, Ohio, United States

Precision Radiotherapy at University Pointe, West Chester, Ohio, United States

Cancer Treatment Center, Wooster, Ohio, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States

Integris Oncology Services, Oklahoma City, Oklahoma, United States

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States

Northeast Radiation Oncology Center, Dunmore, Pennsylvania, United States

Dale and Frances Hughes Cancer Center at Pocono Medical Center, East Stroudsburg, Pennsylvania, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Riddle Memorial Hospital Cancer Center, Media, Pennsylvania, United States

Upper Delaware Valley Cancer Center, Milford, Pennsylvania, United States

Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Frankford Hospital Cancer Center - Torresdale Campus, Philadelphia, Pennsylvania, United States

CCOP - Main Line Health, Wynnewood, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States

Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States

American Fork Hospital, American Fork, Utah, United States

Sandra L. Maxwell Cancer Center, Cedar City, Utah, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah, United States

Dixie Regional Medical Center - East Campus, Saint George, Utah, United States

LDS Hospital, Salt Lake City, Utah, United States

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States

Norris Cotton Cancer Center - North, Saint Johnsbury, Vermont, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton, Virginia, United States

Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, United States

Columbia-Saint Mary's Cancer Care Center, Milwaukee, Wisconsin, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States

London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada

Contact Details

Name: Michael C. Garofalo, MD

Affiliation: University of Maryland Greenebaum Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Name: Adam C. Berger, MD

Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University

Role: STUDY_CHAIR

Name: Johanna Bendell, MD

Affiliation: Duke Cancer Institute

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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