- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00321685
Bevacizumab, Radiation Therapy, and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Nonmetastatic Rectal Cancer
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham Cancer Center
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Connecticut
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New Britain, Connecticut, Estados Unidos, 06050
- The Hospital of Central Connecticut
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital/Winship Cancer Institute
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Decatur, Georgia, Estados Unidos, 30033
- Atlanta VA Medical Center
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Macon, Georgia, Estados Unidos, 31201
- Medical Center of Central Georgia
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Illinois
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Aurora, Illinois, Estados Unidos, 60504
- Rush - Copley Medical Center
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Berwyn, Illinois, Estados Unidos, 60402
- MacNeal Hospital and Cancer Center
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60625
- Swedish Covenant Hospital
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Chicago, Illinois, Estados Unidos, 60611
- Hematology and Oncology Associates
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Chicago, Illinois, Estados Unidos, 60657
- Presence Saint Joseph Hospital-Chicago
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Chicago, Illinois, Estados Unidos, 60612
- Jesse Brown Veterans Affairs Medical Center
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Chicago, Illinois, Estados Unidos, 60616
- Mercy Hospital and Medical Center
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Effingham, Illinois, Estados Unidos, 62401
- Saint Anthony Memorial Hospital
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Highland Park, Illinois, Estados Unidos, 60035
- Hematology Oncology Associates of Illinois-Highland Park
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Hinsdale, Illinois, Estados Unidos, 60521
- Hinsdale Hematology Oncology Associates Incorporated
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Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology-Hematology Associates Limited
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Joliet, Illinois, Estados Unidos, 60432
- Midwest Center for Hematology Oncology
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Libertyville, Illinois, Estados Unidos, 60048
- NorthShore Hematology Oncology-Libertyville
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Moline, Illinois, Estados Unidos, 61265
- Garneau, Stewart C MD (UIA Investigator)
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Moline, Illinois, Estados Unidos, 61265
- Porubcin, Michael MD (UIA Investigator)
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Moline, Illinois, Estados Unidos, 61265
- Spector, David MD (UIA Investigator)
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Moline, Illinois, Estados Unidos, 61265
- Trinity Medical Center
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Moline, Illinois, Estados Unidos, 61265
- Sharis, Christine M MD (UIA Investigator)
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Moline, Illinois, Estados Unidos, 61265
- Stoffel, Thomas J MD (UIA Investigator)
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Moline, Illinois, Estados Unidos, 61265
- Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
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Naperville, Illinois, Estados Unidos, 60563
- DuPage Medical Group-Ogden
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Niles, Illinois, Estados Unidos, 60714
- Illinois Cancer Specialists-Niles
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Skokie, Illinois, Estados Unidos, 60076
- Hematology Oncology Associates of Illinois - Skokie
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Skokie, Illinois, Estados Unidos, 60076
- Edward H Kaplan MD and Associates
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center
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Indiana
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Michigan City, Indiana, Estados Unidos, 46360
- Franciscan Saint Anthony Health-Michigan City
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Iowa
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Bettendorf, Iowa, Estados Unidos, 52722
- Constantinou, Costas L MD (UIA Investigator)
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Estados Unidos, 51102
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, Estados Unidos, 51104
- Saint Luke's Regional Medical Center
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Michigan
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Kalamazoo, Michigan, Estados Unidos, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Estados Unidos, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Estados Unidos, 49048
- Borgess Medical Center
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Minnesota
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Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy Hospital
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Edina, Minnesota, Estados Unidos, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, Estados Unidos, 55432
- Unity Hospital
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Hutchinson, Minnesota, Estados Unidos, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Estados Unidos, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Estados Unidos, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Estados Unidos, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Estados Unidos, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55407
- Virginia Piper Cancer Institute
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Robbinsdale, Minnesota, Estados Unidos, 55422
- North Memorial Medical Health Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- Saint Joseph's Hospital - Healtheast
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Shakopee, Minnesota, Estados Unidos, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Woodbury, Minnesota, Estados Unidos, 55125
- Woodwinds Health Campus
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68510
- Nebraska Cancer Research Center
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Omaha, Nebraska, Estados Unidos, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Estados Unidos, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Estados Unidos, 68131
- Creighton University Medical Center
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Omaha, Nebraska, Estados Unidos, 68106
- Missouri Valley Cancer Consortium
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New Jersey
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Mount Holly, New Jersey, Estados Unidos, 08060
- Virtua Memorial
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Sparta, New Jersey, Estados Unidos, 07871
- Sparta Cancer Treatment Center
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Voorhees, New Jersey, Estados Unidos, 08043
- Virtua Voorhees
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Woodbury, New Jersey, Estados Unidos, 08096
- Inspira Medical Center Woodbury
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New York
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Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center - Moses Campus
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Bronx, New York, Estados Unidos, 10466
- Montefiore Medical Center-Wakefield Campus
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Ohio
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Akron, Ohio, Estados Unidos, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Barberton, Ohio, Estados Unidos, 44203
- Summa Barberton Hospital
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Bellefontaine, Ohio, Estados Unidos, 43311
- Mary Rutan Hospital
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Chillicothe, Ohio, Estados Unidos, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Estados Unidos, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, Estados Unidos, 43228
- Doctors Hospital
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Columbus, Ohio, Estados Unidos, 43215
- Grant Medical Center
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Columbus, Ohio, Estados Unidos, 43222
- Mount Carmel Health Center West
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Delaware, Ohio, Estados Unidos, 43015
- Grady Memorial Hospital
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Lancaster, Ohio, Estados Unidos, 43130
- Fairfield Medical Center
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Lima, Ohio, Estados Unidos, 45801
- Saint Rita's Medical Center
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Marietta, Ohio, Estados Unidos, 45750
- Marietta Memorial Hospital
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Newark, Ohio, Estados Unidos, 43055
- Licking Memorial Hospital
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Springfield, Ohio, Estados Unidos, 45505
- Springfield Regional Medical Center
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Westerville, Ohio, Estados Unidos, 43081
- Saint Ann's Hospital
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Zanesville, Ohio, Estados Unidos, 43701
- Genesis Healthcare System Cancer Care Center
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Valley Hospital-Cedar Crest
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Darby, Pennsylvania, Estados Unidos, 19023-1291
- Mercy Fitzgerald Hospital
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East Stroudsburg, Pennsylvania, Estados Unidos, 18301
- Pocono Medical Center
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Ephrata, Pennsylvania, Estados Unidos, 17522
- Ephrata Cancer Center
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Media, Pennsylvania, Estados Unidos, 19063
- Riddle Memorial Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Estados Unidos, 19141
- Einstein Medical Center Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos, 19114
- Aria Health-Torresdale Campus
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Scranton, Pennsylvania, Estados Unidos, 18508
- Hematology and Oncology Associates of North East Pennsylvania
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Upland, Pennsylvania, Estados Unidos, 19013
- Associates In Hematology Oncology PC-Upland
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Estados Unidos, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Sioux Falls, South Dakota, Estados Unidos, 57104
- Sanford Cancer Center Oncology Clinic
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Medical X-Ray Center
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera McKennan Hospital and University Health Center
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Froedtert and The Medical College of Wisconsin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients must have histologically confirmed, locally advanced, non-metastatic primary T3 or T4 adenocarcinoma of the rectum
- Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
- Patients must not have intra-operative radiotherapy (IORT) or brachytherapy treatment to the pelvis
- The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by proctoscopic examination
- Transmural penetration of tumor through the muscularis propria must be demonstrated by either of the following: computed tomography (CT) scan plus endorectal ultrasound, or a magnetic resonance imaging (MRI); an endorectal coil or pelvic MRI is allowed
- For the patient to be eligible, the surgeon must prospectively define the tumor as either initially resectable or potentially resectable after pre-operative chemoradiation; clinically resectable tumors are defined as completely resectable with negative margins based on routine examination of the non-anesthetized patient; patients whose tumors are not resectable are not eligible; before pre-operative (op) treatment, the surgeon should estimate and record the type of resection anticipated: pelvic exenteration, posterior pelvic exenteration, APR, LAR, or LAR/coloanal anastomosis
Patients with tumors that are clinically fixed, clinical stage T4N0-2, M0 are eligible if it is believed that their tumors are potentially resectable after chemoradiation; based on the following:
- Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum
- Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane will be considered evidence of fixation
- Hydronephrosis on CT scan or intravenous pyelogram (IVP) or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate
- Vaginal or uterine involvement
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- A surgical evaluation must confirm patient's ability to tolerate the proposed surgical procedure
- Patients must have a caloric intake > 1500 kilocalories/day (d)
- Within 4 weeks prior to registration, the patient's absolute neutrophil count (ANC) level must be >= 1,500/mm^3
- Within 4 weeks prior to registration, the patients platelet level must be >= 100,000/mm^3
- Within 4 weeks prior to registration, serum creatinine must be < 1.5 X upper limit of normal (ULN); if serum creatinine > 1.5 x ULN, then creatinine clearance must be >= 50 mL/mm
- Within 4 weeks prior to registration, serum bilirubin must be =< 1.5 X ULN
- Within 4 weeks prior to registration, alkaline phosphatase (alk phos) must be < 2 x ULN
- Within 4 weeks prior to registration, serum glutamic oxaloacetic transaminase (SGOT) must be < 2 x ULN
- Carcinoembryonic antigen (CEA) must be determined prior to initiation of therapy
- Within 4 weeks prior to registration, urine protein/creatinine (UPC) ratio must be < 1; patients with a ratio of >= 1 must undergo a 24-hour urine collection which must be an adequate collection and must demonstrate < 1 gram (gm) of protein in order to participate
- Within 4 weeks prior to registration, albumin must be >= 2 gm/dl
- Absence of clinical evidence of high-grade (lumen diameter < 1 cm) large bowel obstruction, unless diverting colostomy has been performed
- Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 6 months after the completion of bevacizumab
- Women must not be pregnant or breast-feeding; all females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 2 weeks of registration
- Patients must have had no prior chemotherapy for rectal cancer or pelvic irradiation therapy
- Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for > 5 years; patients with prior in situ carcinomas are eligible provided there was complete removal
- Patients must have no active inflammatory bowel disease or other serious medical illness or disease that might limit the patient's ability to receive protocol therapy
- Patients with a history of cerebrovascular accident (CVA)/transient ischemic attack (TIA) at any time, or myocardial infarction/unstable angina within 12 months of study entry are not eligible
- Patients with > grade 1 peripheral neuropathy are not eligible
- Patients must have urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1 gm of protein in order to participate
- Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable regimen of anti-hypertensive therapy
- Patients with clinically significant peripheral vascular disease are not eligible
Patients must not have any of the following:
- Unstable angina (within 12 months of study entry)
- New York Heart Association (NYHA) grade II or higher congestive heart failure
- Evidence of bleeding diathesis/coagulopathy
- Serious non-healing wound or bone fracture
Patients with a history of the following within 28 days prior to registration are not eligible:
- Abdominal fistula
- Gastrointestinal perforation
- Intrabdominal abscess
Patients with a history of the following within 28 days prior to day 0 (first treatment day) are not eligible:
- Major surgical procedure
- Open biopsy
- Significant traumatic injury
- Patients must not have core biopsy within 7 days prior to day 0 (first treatment day)
Patients with prothrombin time (PT) (international normalized ratio [INR]) > 1.5 are not eligible, unless the patient is on full-dose anticoagulants; if so, the following criteria must be met for enrollment:
- The subject must have an in-range INR (usually between 2 and 3), be on a stable dose of warfarin or on a stable dose of low molecular weight heparin
- The subject must not have active bleeding or a pathological condition that is associated with a high risk of bleeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Treatment (bevacizumab and chemoradiotherapy)
See Detailed Description
|
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Orden de compra dada
Otros nombres:
Dado IV
Otros nombres:
Someterse a una resección quirúrgica
Someterse a radioterapia
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pathologic Complete Response Rate
Periodo de tiempo: Assessed at surgery time
|
Pathologic complete response to preoperative therapy was determined at the time of surgical resection.
Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response).
Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients
|
Assessed at surgery time
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Resection Rate for T3 Rectal Cancers
Periodo de tiempo: Assessed at surgery time
|
Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers
|
Assessed at surgery time
|
Resection Rate for T4 Rectal Cancers
Periodo de tiempo: Assessed at surgery time
|
Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers
|
Assessed at surgery time
|
5-year Overall Survival Rate
Periodo de tiempo: survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
|
Overall survival is defined as time from registration to death from any cause.
5-year overall survival rate is estimated using Kaplan-Meier method.
|
survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
|
5-year Recurrence-free Survival Rate
Periodo de tiempo: recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
|
Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients.
5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.
|
recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jerome C Landry, ECOG-ACRIN Cancer Research Group
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias colorrectales
- Neoplasias Rectales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Protectores
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Micronutrientes
- Vitaminas
- Agentes de conservación de la densidad ósea
- Hormonas y agentes reguladores del calcio
- Antídotos
- Complejo de vitamina B
- Hematínicos
- Anticuerpos
- Fluorouracilo
- Capecitabina
- Oxaliplatino
- Inmunoglobulinas
- Bevacizumab
- Leucovorina
- Calcio
- Levoleucovorina
- Anticuerpos Monoclonales
- Agentes antineoplásicos inmunológicos
- Ácido fólico
- Calcio, Dietético
- Inmunoglobulina G
- Factores de crecimiento endotelial
Otros números de identificación del estudio
- NCI-2009-01081 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- U10CA180820 (Subvención/contrato del NIH de EE. UU.)
- U10CA021115 (Subvención/contrato del NIH de EE. UU.)
- CDR0000471148
- ECOG-E3204
- E3204 (Otro identificador: CTEP)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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-
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National Cancer Institute (NCI)TerminadoAdenocarcinoma de cuello uterino | Carcinoma adenoescamoso de cuello uterino | Carcinoma de células escamosas de cuello uterino, no especificado | Cáncer de cuello uterino en estadio IVA AJCC v6 y v7 | Carcinoma cervical recurrente | Cáncer de cuello uterino en estadio IV AJCC v6 y v7 | Cáncer...Estados Unidos
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsReclutamientoCarcinoma de trompa de Falopio recidivante | Carcinoma de ovario recurrente | Carcinoma peritoneal primario recidivante | Adenocarcinoma seroso endometrial recidivante | Adenocarcinoma de células claras de ovario | Carcinoma de ovario resistente al platino recurrente | Carcinoma de ovario sensible... y otras condicionesEstados Unidos
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National Cancer Institute (NCI)ReclutamientoSarcoma alveolar metastásico de partes blandas | Sarcoma alveolar de partes blandas irresecableEstados Unidos
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City of Hope Medical CenterNational Cancer Institute (NCI)Activo, no reclutandoCarcinoma de células no pequeñas de pulmón metastásico | Cáncer de pulmón en estadio IVA AJCC v8 | Cáncer de pulmón en estadio IVB AJCC v8 | Cáncer de pulmón en estadio III AJCC v8 | Cáncer de pulmón en estadio IV AJCC v8 | Cáncer de pulmón en estadio IIIA AJCC v8 | Cáncer de pulmón en estadio... y otras condicionesEstados Unidos