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

27 août 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

79

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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)
Médicament: oxaliplatine
Autres noms:
  • 50 mg/m^2 IV pendant 2 heures par semaine pendant cinq semaines à partir du jour 1 de la radiothérapie.
Médicament: capecitabine
1650 mg/m^2/day orally 5 days/week during radiotherapy.
Procédure: 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.
Radiation: 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
Médicament: 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.

Autres noms:
  • Oxaliplatin, leucovorin, 5-fluorouracil

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Radiation Therapy Oncology Group

Collaborateurs

National Cancer Institute (NCI)
NRG Oncology

Les enquêteurs

  • Chercheur principal: Michael C. Garofalo, MD, University of Maryland Greenebaum Cancer Center
  • Chaise d'étude: Adam C. Berger, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
  • Chaise d'étude: Johanna Bendell, MD, Duke Cancer Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2008

Achèvement primaire (Réel)

1 janvier 2010

Achèvement de l'étude (Réel)

1 décembre 2016

Dates d'inscription aux études

Première soumission

9 février 2008

Première soumission répondant aux critères de contrôle qualité

9 février 2008

Première publication (Estimation)

12 février 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2018

Dernière vérification

1 juillet 2018

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Autres numéros d'identification d'étude

  • RTOG-0822
  • CDR0000586277

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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