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

13. března 2019 aktualizováno: National Cancer Institute (NCI)

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

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

57

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35233
        • University of Alabama at Birmingham Cancer Center
    • Connecticut
      • New Britain, Connecticut, Spojené státy, 06050
        • The Hospital of Central Connecticut
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Decatur, Georgia, Spojené státy, 30033
        • Atlanta VA Medical Center
      • Macon, Georgia, Spojené státy, 31201
        • Medical Center of Central Georgia
    • Illinois
      • Aurora, Illinois, Spojené státy, 60504
        • Rush - Copley Medical Center
      • Berwyn, Illinois, Spojené státy, 60402
        • MacNeal Hospital and Cancer Center
      • Chicago, Illinois, Spojené státy, 60611
        • Northwestern University
      • Chicago, Illinois, Spojené státy, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, Spojené státy, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, Spojené státy, 60657
        • Presence Saint Joseph Hospital-Chicago
      • Chicago, Illinois, Spojené státy, 60612
        • Jesse Brown Veterans Affairs Medical Center
      • Chicago, Illinois, Spojené státy, 60616
        • Mercy Hospital and Medical Center
      • Effingham, Illinois, Spojené státy, 62401
        • Saint Anthony Memorial Hospital
      • Highland Park, Illinois, Spojené státy, 60035
        • Hematology Oncology Associates of Illinois-Highland Park
      • Hinsdale, Illinois, Spojené státy, 60521
        • Hinsdale Hematology Oncology Associates Incorporated
      • Joliet, Illinois, Spojené státy, 60435
        • Joliet Oncology-Hematology Associates Limited
      • Joliet, Illinois, Spojené státy, 60432
        • Midwest Center for Hematology Oncology
      • Libertyville, Illinois, Spojené státy, 60048
        • NorthShore Hematology Oncology-Libertyville
      • Moline, Illinois, Spojené státy, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, Spojené státy, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, Spojené státy, 61265
        • Spector, David MD (UIA Investigator)
      • Moline, Illinois, Spojené státy, 61265
        • Trinity Medical Center
      • Moline, Illinois, Spojené státy, 61265
        • Sharis, Christine M MD (UIA Investigator)
      • Moline, Illinois, Spojené státy, 61265
        • Stoffel, Thomas J MD (UIA Investigator)
      • Moline, Illinois, Spojené státy, 61265
        • Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
      • Naperville, Illinois, Spojené státy, 60563
        • DuPage Medical Group-Ogden
      • Niles, Illinois, Spojené státy, 60714
        • Illinois Cancer Specialists-Niles
      • Skokie, Illinois, Spojené státy, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Skokie, Illinois, Spojené státy, 60076
        • Edward H Kaplan MD and Associates
      • Urbana, Illinois, Spojené státy, 61801
        • Carle Cancer Center
    • Indiana
      • Michigan City, Indiana, Spojené státy, 46360
        • Franciscan Saint Anthony Health-Michigan City
    • Iowa
      • Bettendorf, Iowa, Spojené státy, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Sioux City, Iowa, Spojené státy, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Spojené státy, 51102
        • Mercy Medical Center-Sioux City
      • Sioux City, Iowa, Spojené státy, 51104
        • Saint Luke's Regional Medical Center
    • Michigan
      • Kalamazoo, Michigan, Spojené státy, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Spojené státy, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Spojené státy, 49048
        • Borgess Medical Center
    • Minnesota
      • Burnsville, Minnesota, Spojené státy, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Spojené státy, 55433
        • Mercy Hospital
      • Edina, Minnesota, Spojené státy, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Spojené státy, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Spojené státy, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, Spojené státy, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, Spojené státy, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Spojené státy, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Spojené státy, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Spojené státy, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Spojené státy, 55407
        • Virginia Piper Cancer Institute
      • Robbinsdale, Minnesota, Spojené státy, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Spojené státy, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Spojené státy, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, Spojené státy, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Spojené státy, 55102
        • United Hospital
      • Saint Paul, Minnesota, Spojené státy, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, Spojené státy, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, Spojené státy, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Spojené státy, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Woodbury, Minnesota, Spojené státy, 55125
        • Woodwinds Health Campus
    • Nebraska
      • Lincoln, Nebraska, Spojené státy, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, Spojené státy, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Spojené státy, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Spojené státy, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, Spojené státy, 68106
        • Missouri Valley Cancer Consortium
    • New Jersey
      • Mount Holly, New Jersey, Spojené státy, 08060
        • Virtua Memorial
      • Sparta, New Jersey, Spojené státy, 07871
        • Sparta Cancer Treatment Center
      • Voorhees, New Jersey, Spojené státy, 08043
        • Virtua Voorhees
      • Woodbury, New Jersey, Spojené státy, 08096
        • Inspira Medical Center Woodbury
    • New York
      • Bronx, New York, Spojené státy, 10467
        • Montefiore Medical Center - Moses Campus
      • Bronx, New York, Spojené státy, 10466
        • Montefiore Medical Center-Wakefield Campus
    • Ohio
      • Akron, Ohio, Spojené státy, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Barberton, Ohio, Spojené státy, 44203
        • Summa Barberton Hospital
      • Bellefontaine, Ohio, Spojené státy, 43311
        • Mary Rutan Hospital
      • Chillicothe, Ohio, Spojené státy, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Spojené státy, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Spojené státy, 43228
        • Doctors Hospital
      • Columbus, Ohio, Spojené státy, 43215
        • Grant Medical Center
      • Columbus, Ohio, Spojené státy, 43222
        • Mount Carmel Health Center West
      • Delaware, Ohio, Spojené státy, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, Spojené státy, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Spojené státy, 45801
        • Saint Rita's Medical Center
      • Marietta, Ohio, Spojené státy, 45750
        • Marietta Memorial Hospital
      • Newark, Ohio, Spojené státy, 43055
        • Licking Memorial Hospital
      • Springfield, Ohio, Spojené státy, 45505
        • Springfield Regional Medical Center
      • Westerville, Ohio, Spojené státy, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, Spojené státy, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Tulsa, Oklahoma, Spojené státy, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Pennsylvania
      • Allentown, Pennsylvania, Spojené státy, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Darby, Pennsylvania, Spojené státy, 19023-1291
        • Mercy Fitzgerald Hospital
      • East Stroudsburg, Pennsylvania, Spojené státy, 18301
        • Pocono Medical Center
      • Ephrata, Pennsylvania, Spojené státy, 17522
        • Ephrata Cancer Center
      • Media, Pennsylvania, Spojené státy, 19063
        • Riddle Memorial Hospital
      • Philadelphia, Pennsylvania, Spojené státy, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Spojené státy, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Spojené státy, 19141
        • Einstein Medical Center Philadelphia
      • Philadelphia, Pennsylvania, Spojené státy, 19114
        • Aria Health-Torresdale Campus
      • Scranton, Pennsylvania, Spojené státy, 18508
        • Hematology and Oncology Associates of North East Pennsylvania
      • Upland, Pennsylvania, Spojené státy, 19013
        • Associates In Hematology Oncology PC-Upland
    • South Dakota
      • Sioux Falls, South Dakota, Spojené státy, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Spojené státy, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Spojené státy, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, Spojené státy, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, Spojené státy, 57105
        • Avera McKennan Hospital and University Health Center
    • Texas
      • Dallas, Texas, Spojené státy, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
    • Wisconsin
      • La Crosse, Wisconsin, Spojené státy, 54601
        • Gundersen Lutheran Medical Center
      • Milwaukee, Wisconsin, Spojené státy, 53226
        • Froedtert and The Medical College of Wisconsin

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Treatment (bevacizumab and chemoradiotherapy)
See Detailed Description
Biologický: Bevacizumab
Vzhledem k tomu, IV
Ostatní jména:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF humanizovaná monoklonální protilátka
  • Anti-VEGF rhuMAb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar QL 1101
  • Imunoglobulin G1 (lidský-myší monoklonální rhuMab-VEGF gama-řetězcový anti-lidský vaskulární endoteliální růstový faktor), disulfid s lidským-myším monoklonálním lehkým řetězcem rhuMab-VEGF, dimer
  • Rekombinantní humanizovaná anti-VEGF monoklonální protilátka
  • rhuMab-VEGF
  • BEVACIZUMAB, DRŽITEL LICENCE NEUVEDEN
Lék: Fluorouracil
Vzhledem k tomu, IV
Ostatní jména:
  • 5-FU
  • 5-Fluracil
  • Fluracil
  • 5-Fluor-2,4(lH,3H)-pyrimidindion
  • 5-Fluoruracil
  • AccuSite
  • Carac
  • Fluoro uracil
  • Fluuracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Lék: Oxaliplatina
Vzhledem k tomu, IV
Ostatní jména:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • Ai Heng
  • Aiheng
  • Diaminocyklohexan Oxalatoplatina
  • JM-83
  • Oxalatoplatina
  • RP 54780
  • RP-54780
  • SR-96669
Lék: Kapecitabin
Vzhledem k PO
Ostatní jména:
  • Xeloda
  • Ro 09-1978/000
Lék: Leukovorin vápník
Vzhledem k tomu, IV
Ostatní jména:
  • Wellcovorin
  • citrovorový faktor
  • kyselina folinová
  • Adinepar
  • Kalcifolin
  • (6S)-folinát vápenatý
  • Folinát vápenatý
  • Leukovorin vápníku
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Cromatonbic Folinico
  • Dalisol
  • Dezinfekce
  • Divical
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-buňka
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinát vápníku
  • Pentahydrát vápenaté soli kyseliny folinové
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leukovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Postup: Terapeutická konvenční chirurgie
Podstoupit chirurgickou resekci
Záření: Radiační terapie
Podstoupit radioterapii
Ostatní jména:
  • Radioterapie rakoviny
  • Ozářit
  • Ozářené
  • Záření
  • Radioterapeutika
  • RT
  • Terapie, záření
  • ozáření
  • RADIOTERAPIE

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pathologic Complete Response Rate
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Resection Rate for T3 Rectal Cancers
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jerome C Landry, ECOG-ACRIN Cancer Research Group

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. července 2006

Primární dokončení (Aktuální)

12. srpna 2013

Dokončení studie (Aktuální)

11. února 2019

Termíny zápisu do studia

První předloženo

2. května 2006

První předloženo, které splnilo kritéria kontroly kvality

2. května 2006

První zveřejněno (Odhad)

4. května 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. března 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. března 2019

Naposledy ověřeno

1. března 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NCI-2009-01081 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (Grant/smlouva NIH USA)
  • U10CA021115 (Grant/smlouva NIH USA)
  • CDR0000471148
  • ECOG-E3204
  • E3204 (Jiný identifikátor: CTEP)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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