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

27 agosto 2018 aggiornato da: Radiation Therapy Oncology Group

A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity (grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with conventionally delivered radiotherapy, as was utilized in the capecitabine and oxaliplatin arm of RTOG-0247 (NCT00081289).

Secondary

  • To evaluate the feasibility of performing IMRT in a cooperative group setting for the treatment of rectal cancer.
  • To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment in the neoadjuvant period, the adjuvant period, and overall.
  • To estimate the pathologic complete response rate following neoadjuvant IMRT-based chemoradiotherapy.
  • To estimate the time to treatment failure and patterns of failure.
  • To correlate pre- and post-treatment levels of serum cytokines with symptoms during and pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer.
  • To evaluate the rate of abdominoperineal resections.

OUTLINE: This is a multicenter study.

  • Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy). Beginning on the first day of radiotherapy and continuing through completion of radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5 weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29.
  • Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo resection of the rectal tumor.
  • Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely resected disease and negative surgical margins receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

79

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
  • Stati Uniti
    • Alabama
      • Mobile, Alabama, Stati Uniti, 36608
        • Providence Cancer Center at Providence Hospital
    • California
      • Auburn, California, Stati Uniti, 95603
        • Auburn Radiation Oncology
      • Cameron Park, California, Stati Uniti, 95682
        • Radiation Oncology Centers - Cameron Park
      • Carmichael, California, Stati Uniti, 95608
        • Mercy Cancer Center at Mercy San Juan Medical Center
      • Duarte, California, Stati Uniti, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Fresno, California, Stati Uniti, 93720
        • California Cancer Center - Woodward Park Office
      • La Jolla, California, Stati Uniti, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Roseville, California, Stati Uniti, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Stati Uniti, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • Sacramento, California, Stati Uniti, 95819
        • Mercy General Hospital
      • San Diego, California, Stati Uniti, 92161
        • Veterans Affairs Medical Center - San Diego
      • Vacaville, California, Stati Uniti, 95687
        • Solano Radiation Oncology Center
    • Florida
      • Boca Raton, Florida, Stati Uniti, 33486
        • Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
      • Gainesville, Florida, Stati Uniti, 32610-0232
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, Stati Uniti, 32207
        • Baptist Cancer Institute - Jacksonville
      • Miami, Florida, Stati Uniti, 33176
        • Baptist-South Miami Regional Cancer Program
      • Orange Park, Florida, Stati Uniti, 32073
        • Integrated Community Oncology Network - Orange Park
      • Panama City, Florida, Stati Uniti, 32401
        • Bay Medical
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
        • Piedmont Hospital
      • Columbus, Georgia, Stati Uniti, 31904
        • John B. Amos Cancer Center
      • Savannah, Georgia, Stati Uniti, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Springfield, Illinois, Stati Uniti, 62702
        • Cancer Institute at St. John's Hospital
    • Indiana
      • Anderson, Indiana, Stati Uniti, 46016
        • Saint John's Cancer Center at Saint John's Medical Center
      • Goshen, Indiana, Stati Uniti, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Indianapolis, Indiana, Stati Uniti, 46260
        • St. Vincent Oncology Center
      • Muncie, Indiana, Stati Uniti, 47303-3499
        • Cancer Center at Ball Memorial Hospital
    • Kansas
      • Overland Park, Kansas, Stati Uniti, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Stati Uniti, 66213
        • Saint Luke's Hospital - South
      • Shawnee Mission, Kansas, Stati Uniti, 66204
        • Shawnee Mission Medical Center
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stati Uniti, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Stati Uniti, 02118
        • Boston University Cancer Research Center
      • Boston, Massachusetts, Stati Uniti, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
      • Fall River, Massachusetts, Stati Uniti, 02721
        • Hudner Oncology Center at Saint Anne's Hospital - Fall River
    • Minnesota
      • Burnsville, Minnesota, Stati Uniti, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, Stati Uniti, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Stati Uniti, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Maplewood, Minnesota, Stati Uniti, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Robbinsdale, Minnesota, Stati Uniti, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • United Hospital
      • Shakopee, Minnesota, Stati Uniti, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Waconia, Minnesota, Stati Uniti, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Stati Uniti, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Mississippi
      • Pascagoula, Mississippi, Stati Uniti, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, Stati Uniti, 63703
        • Cancer Institute of Cape Girardeau, LLC
      • Kansas City, Missouri, Stati Uniti, 64131
        • CCOP - Kansas City
      • Kansas City, Missouri, Stati Uniti, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Stati Uniti, 64132
        • Research Medical Center
      • Kansas City, Missouri, Stati Uniti, 64108
        • Truman Medical Center - Hospital Hill
      • Kansas City, Missouri, Stati Uniti, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, Stati Uniti, 64114
        • St. Joseph Medical Center
      • Kansas City, Missouri, Stati Uniti, 64116
        • Parvin Radiation Oncology
      • Lee's Summit, Missouri, Stati Uniti, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Stati Uniti, 64068
        • Liberty Hospital
      • Saint Joseph, Missouri, Stati Uniti, 64506
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, Stati Uniti, 63141
        • Barnes-Jewish West County Hospital
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Peters, Missouri, Stati Uniti, 63376
        • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
      • Springfield, Missouri, Stati Uniti, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Stati Uniti, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198
        • Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • CCOP - Nevada Cancer Research Foundation
      • Reno, Nevada, Stati Uniti, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Keene, New Hampshire, Stati Uniti, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Long Branch, New Jersey, Stati Uniti, 07740-6395
        • Monmouth Medical Center
      • Marlton, New Jersey, Stati Uniti, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Toms River, New Jersey, Stati Uniti, 08755
        • J. Phillip Citta Regional Cancer Center at Community Medical Center
    • New York
      • Brooklyn, New York, Stati Uniti, 11219
        • Maimonides Cancer Center at Maimonides Medical Center
      • Lake Success, New York, Stati Uniti, 11042
        • Monter Cancer Center of the North Shore-LIJ Health System
      • Manhasset, New York, Stati Uniti, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Stati Uniti, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park, New York, Stati Uniti, 11040
        • Long Island Jewish Medical Center
    • North Carolina
      • Goldsboro, North Carolina, Stati Uniti, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, Stati Uniti, 27534
        • Wayne Memorial Hospital, Incorporated
    • Ohio
      • Akron, Ohio, Stati Uniti, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Barberton, Ohio, Stati Uniti, 44203
        • Barberton Citizens Hospital
      • Cincinnati, Ohio, Stati Uniti, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Columbus, Ohio, Stati Uniti, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
      • Salem, Ohio, Stati Uniti, 44460
        • Cancer Care Center, Incorporated
      • West Chester, Ohio, Stati Uniti, 45069
        • Precision Radiotherapy at University Pointe
      • Wooster, Ohio, Stati Uniti, 44691
        • Cancer Treatment Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Oklahoma University Cancer Institute
      • Oklahoma City, Oklahoma, Stati Uniti, 73112
        • Integris Oncology Services
    • Pennsylvania
      • Abington, Pennsylvania, Stati Uniti, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, Stati Uniti, 19010
        • Bryn Mawr Hospital
      • Dunmore, Pennsylvania, Stati Uniti, 18512
        • Northeast Radiation Oncology Center
      • East Stroudsburg, Pennsylvania, Stati Uniti, 18301
        • Dale and Frances Hughes Cancer Center at Pocono Medical Center
      • Hershey, Pennsylvania, Stati Uniti, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Media, Pennsylvania, Stati Uniti, 19063
        • Riddle Memorial Hospital Cancer Center
      • Milford, Pennsylvania, Stati Uniti, 18337
        • Upper Delaware Valley Cancer Center
      • Paoli, Pennsylvania, Stati Uniti, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Stati Uniti, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, Stati Uniti, 19114
        • Frankford Hospital Cancer Center - Torresdale Campus
      • Wynnewood, Pennsylvania, Stati Uniti, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • Wynnewood, Pennsylvania, Stati Uniti, 19096
        • CCOP - Main Line Health
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Tennessee
      • Kingsport, Tennessee, Stati Uniti, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Utah
      • American Fork, Utah, Stati Uniti, 84003
        • American Fork Hospital
      • Cedar City, Utah, Stati Uniti, 84720
        • Sandra L. Maxwell Cancer Center
      • Murray, Utah, Stati Uniti, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Stati Uniti, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Stati Uniti, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Stati Uniti, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Stati Uniti, 84103
        • LDS Hospital
      • Salt Lake City, Utah, Stati Uniti, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Vermont
      • Saint Johnsbury, Vermont, Stati Uniti, 05819
        • Norris Cotton Cancer Center - North
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • University of Virginia Cancer Center
      • Norton, Virginia, Stati Uniti, 24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
    • Wisconsin
      • Mequon, Wisconsin, Stati Uniti, 53097
        • Columbia Saint Mary's Hospital - Ozaukee
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Stati Uniti, 53211
        • Columbia-Saint Mary's Cancer Care Center

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

DISEASE CHARACTERISTICS:

  • Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)

    • Located up to 12 cm from the anal verge with no extension of malignant disease into the anal canal

    • Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by the following assessments:

      • Colonoscopy and biopsy within 56 days prior to registration
      • History/physical examination (including medication history screen for contraindications) within 56 days prior to registration
      • Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography(CT), MRI, or Positron-emission tomography(PET)-CT (whole body preferred) within 56 days prior to registration
      • Chest x-ray (or CT) of the chest within within 56 days prior to registration to exclude distant metastases (except for patients who have had whole body PET-CT)

      • Transrectal ultrasound (TRUS) within 56 days prior to registration required to establish tumor stage

        • TRUS not required if clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion
  • No synchronous primary colon carcinoma
  • No evidence of distant metastases (M1)

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
  • Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine clearance > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years

Exclusion criteria:

  • Severe, active comorbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS
    • Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
    • Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
    • Evidence of peripheral neuropathy ≥ grade 2
  • Prior allergic reaction to oxaliplatin or capecitabine
  • Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
  • Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection)
  • Participation in any investigational drug study within 28 days of study enrollment.
  • Concurrent cimetidine, amifostine, and/or depot Sandostatin

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
Altro: IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Droga: oxaliplatino
Altri nomi:
  • 50 mg/m^2 EV per 2 ore settimanali per cinque settimane a partire dal giorno 1 della radioterapia.
Droga: capecitabine
1650 mg/m^2/day orally 5 days/week during radiotherapy.
Procedura: resection
All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.
Radiazione: radiation therapy
Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx
Droga: FOLFOX

Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1.

Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1.

Altri nomi:
  • Oxaliplatin, leucovorin, 5-fluorouracil

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
Lasso di tempo: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.
From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Lasso di tempo: Pretreatment
Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.
Pretreatment
Number of Patients With Pathologic Complete Response
Lasso di tempo: At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Lasso di tempo: From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;
From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
Local-regional Failure: 4-year Rate
Lasso di tempo: From registration to four years
Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.
From registration to four years
Distant Failure: 4-year Rate
Lasso di tempo: From registration to four years
Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.
From registration to four years
Overall Survival: 4-year Rate
Lasso di tempo: From registration to four years
Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
From registration to four years
Disease-free Survival: 4-year Rate
Lasso di tempo: From registration to four years
Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.
From registration to four years
Number of Patients Who Underwent Abdominoperineal Resection
Lasso di tempo: Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.
Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.

Collaboratori e investigatori

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

Sponsor

Radiation Therapy Oncology Group

Collaboratori

National Cancer Institute (NCI)
NRG Oncology

Investigatori

  • Investigatore principale: Michael C. Garofalo, MD, University of Maryland Greenebaum Cancer Center
  • Cattedra di studio: Adam C. Berger, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Cattedra di studio: Johanna Bendell, MD, Duke Cancer Institute

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

1 aprile 2008

Completamento primario (Effettivo)

1 gennaio 2010

Completamento dello studio (Effettivo)

1 dicembre 2016

Date di iscrizione allo studio

Primo inviato

9 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

9 febbraio 2008

Primo Inserito (Stima)

12 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2018

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RTOG-0822
  • CDR0000586277

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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