⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer

Official Title: Phase II Study of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin and Bevacizumab Followed by Surgery and Postoperative 5-FU, Leucovorin, Oxaliplatin (FOLFOX) and Bevacizumab in Patients With Locally Advanced Rectal Cancer

Study ID: NCT00321685

Study Description

Brief Summary: This phase II trial studies how well giving bevacizumab, radiation therapy, and combination chemotherapy works in treating patients who are undergoing surgery for locally advanced nonmetastatic rectal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab together with combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the pathological complete response rate in patients with T3 and T4 rectal cancers when treated preoperatively with capecitabine, oxaliplatin, bevacizumab, and concurrent radiotherapy (XRT). II. To evaluate the resection rate for T3 and T4 rectal cancers and the expected versus actual type of resection (abdominoperinal resection \[APR\] vs. low anterior resection \[LAR\] vs. LAR/coloanal anastomosis). III. To make preliminary observations of patient survival and patterns of recurrence for this treatment combination. IV. To gain additional experience regarding the toxicity and tolerability of this preoperative and postoperative regimen. OUTLINE: PREOPERATIVE CHEMORADIOTHERAPY: Patients undergo radiotherapy (total dose to the tumor bed was 5040 cGy) once daily (QD) 5 days a week and receive capecitabine 825 mg/m\^2 orally (PO) twice daily (BID) 5 days a week for 5.5 weeks. Patients also receive oxaliplatin 50 mg/m\^2 intravenously (IV) over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab 5 mg/kg IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy. SURGERY: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection. Patients whose tumors are not completely resected or who have metastatic disease discontinue protocol therapy. POSTOPERATIVE CHEMOTHERAPY: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium 400 mg/m\^2 IV over 2 hours, and bevacizumab 5 mg/kg IV over 30-90 minutes on day 1. Patients also receive fluorouracil 2400 mg/m\^2 IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients then receive up to 3 additional courses of leucovorin calcium, fluorouracil, and bevacizumab. After completion of study treatment, patients are followed up periodically for 10 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

The Hospital of Central Connecticut, New Britain, Connecticut, United States

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

Atlanta VA Medical Center, Decatur, Georgia, United States

Medical Center of Central Georgia, Macon, Georgia, United States

Rush - Copley Medical Center, Aurora, Illinois, United States

MacNeal Hospital and Cancer Center, Berwyn, Illinois, United States

Hematology and Oncology Associates, Chicago, Illinois, United States

Northwestern University, Chicago, Illinois, United States

Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois, United States

Mercy Hospital and Medical Center, Chicago, Illinois, United States

Swedish Covenant Hospital, Chicago, Illinois, United States

Presence Saint Joseph Hospital-Chicago, Chicago, Illinois, United States

Saint Anthony Memorial Hospital, Effingham, Illinois, United States

Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States

Midwest Center for Hematology Oncology, Joliet, Illinois, United States

Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States

NorthShore Hematology Oncology-Libertyville, Libertyville, Illinois, United States

Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States

Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States

Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States

Spector, David MD (UIA Investigator), Moline, Illinois, United States

Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States

Trinity Medical Center, Moline, Illinois, United States

Vigliotti, Antonio, P.G. M.D. (UIA Investigator), Moline, Illinois, United States

DuPage Medical Group-Ogden, Naperville, Illinois, United States

Illinois Cancer Specialists-Niles, Niles, Illinois, United States

Edward H Kaplan MD and Associates, Skokie, Illinois, United States

Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States

Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

Mercy Medical Center-Sioux City, Sioux City, Iowa, United States

Saint Luke's Regional Medical Center, Sioux City, Iowa, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview-Southdale Hospital, Edina, Minnesota, United States

Unity Hospital, Fridley, Minnesota, United States

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

Meeker County Memorial Hospital, Litchfield, Minnesota, United States

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

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

Saint Joseph's Hospital - Healtheast, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

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

Woodwinds Health Campus, Woodbury, Minnesota, United States

Nebraska Cancer Research Center, Lincoln, Nebraska, United States

Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Virtua Memorial, Mount Holly, New Jersey, United States

Sparta Cancer Treatment Center, Sparta, New Jersey, United States

Virtua Voorhees, Voorhees, New Jersey, United States

Inspira Medical Center Woodbury, Woodbury, New Jersey, United States

Montefiore Medical Center-Wakefield Campus, Bronx, New York, United States

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States

Summa Barberton Hospital, Barberton, Ohio, United States

Mary Rutan Hospital, Bellefontaine, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Saint Rita's Medical Center, Lima, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Mercy Fitzgerald Hospital, Darby, Pennsylvania, United States

Pocono Medical Center, East Stroudsburg, Pennsylvania, United States

Ephrata Cancer Center, Ephrata, Pennsylvania, United States

Riddle Memorial Hospital, Media, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Aria Health-Torresdale Campus, Philadelphia, Pennsylvania, United States

Einstein Medical Center Philadelphia, Philadelphia, Pennsylvania, United States

Hematology and Oncology Associates of North East Pennsylvania, Scranton, Pennsylvania, United States

Associates In Hematology Oncology PC-Upland, Upland, Pennsylvania, United States

Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States

Avera Cancer Institute, Sioux Falls, South Dakota, United States

Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States

Medical X-Ray Center, Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Contact Details

Name: Jerome C Landry

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: