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

13 marzo 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

57

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treatment (bevacizumab and chemoradiotherapy)
See Detailed Description
Biologico: Bevacizumab
Dato IV
Altri nomi:
  • Avastin
  • Anti-VEGF
  • Anticorpo monoclonale umanizzato anti-VEGF
  • Anti-VEGF rhuMAb
  • Bevacizumab biosimilare BEVZ92
  • Bevacizumab biosimilare BI 695502
  • Bevacizumab biosimilare CBT 124
  • Bevacizumab biosimilare FKB238
  • Bevacizumab biosimilare MIL60
  • Bevacizumab biosimilare QL 1101
  • Immunoglobulina G1 (fattore di crescita endoteliale vascolare monoclonale umano-topo rhuMab-VEGF anti-catena gamma), disolfuro con catena leggera monoclonale umano-topo rhuMab-VEGF, dimero
  • Anticorpo monoclonale anti-VEGF umanizzato ricombinante
  • rhuMab-VEGF
  • BEVACIZUMAB, TITOLARE DI LICENZA NON SPECIFICATO
Droga: Fluorouracile
Dato IV
Altri nomi:
  • 5-FU
  • 5-Fluracile
  • Fluracil
  • 5-Fluoro-2,4(1H, 3H)-pirimidinedione
  • 5-Fluorouracile
  • Accu Site
  • Carac
  • Fluorouracile
  • Fluuracile
  • Flurablastina
  • Fluracedil
  • Fluril
  • Fluroblastina
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Droga: Oxaliplatino
Dato IV
Altri nomi:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatina
  • Ai Heng
  • Aiheng
  • Diamminocicloesano ossalatoplatino
  • JM-83
  • Oxalatoplatino
  • RP 54780
  • RP-54780
  • SR-96669
Droga: Capecitabina
Dato PO
Altri nomi:
  • Xeloda
  • Ro 09-1978/000
Droga: Leucovorina Calcio
Dato IV
Altri nomi:
  • Wellcovorin
  • fattore citrovorum
  • acido folinico
  • Adinepar
  • Calcifolina
  • Calcio (6S)-folinato
  • Folinato di calcio
  • Leucovorina di calcio
  • Calfox
  • Calinat
  • Cehafolin
  • Citofolina
  • Citrec
  • Cromatonbico Folinico
  • Dalisol
  • Disintossicazione
  • Divical
  • Ecofol
  • Emovis
  • Fattore, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxina
  • FOLI-cella
  • Folben
  • Folidano
  • Folidar
  • Folinac
  • Calcio folinato
  • Acido Folinico Sale di Calcio Pentaidrato
  • Folinorale
  • Folinvit
  • Folplus
  • Flix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leucovorin
  • Rescufolina
  • Rescuvolin
  • Tonofolina
Procedura: Chirurgia terapeutica convenzionale
Sottoponiti a resezione chirurgica
Radiazione: Radioterapia
Sottoponiti a radioterapia
Altri nomi:
  • Radioterapia del cancro
  • Irradiare
  • Irradiato
  • Radiazione
  • Radioterapia
  • RT
  • Terapia, radiazioni
  • irradiazione
  • RADIOTERAPIA

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pathologic Complete Response Rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resection Rate for T3 Rectal Cancers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Jerome C Landry, ECOG-ACRIN Cancer Research Group

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 luglio 2006

Completamento primario (Effettivo)

12 agosto 2013

Completamento dello studio (Effettivo)

11 febbraio 2019

Date di iscrizione allo studio

Primo inviato

2 maggio 2006

Primo inviato che soddisfa i criteri di controllo qualità

2 maggio 2006

Primo Inserito (Stima)

4 maggio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2009-01081 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U10CA021115 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000471148
  • ECOG-E3204
  • E3204 (Altro identificatore: CTEP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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