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Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
 
Region Sponsors
California - Southern
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
National Cancer Institute (NCI)
North Central Cancer Treatment Group
 
Acronym KP IRB No.
10143
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Patients with Colorectal Cancer.
 
Purpose
This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Radiologically measurable or clinically evaluable disease
  • ECOG performance status 0, 1, or 2
  • Absolute neutrophil count (ANC) =/> 1,500/mm³
  • Platelets =/> 100,000/mm³
  • Hemoglobin > 8.0 g/dL
  • Total bilirubin =/< 1.5 times upper limit of normal (ULN)
  • AST and ALT =/< 3 times ULN
  • Creatinine =/< 1.5 times ULN
 
Exclusion Criteria
  • Chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is =/> 5 years)
  • Prior pelvic radiation
  • Tumor causing symptomatic bowel obstruction

 
Keywords and/or Specific Medical Conditions
  • Antimetabolites
  • Levoleucovorin
  • Antimetabolites, Antineoplastic
  • Micronutrients
  • Antineoplastic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Capecitabine
  • Neoplasms
  • Colonic Diseases
  • Neoplasms by Site
  • Colorectal Neoplasms
  • Oxaliplatin
  • Digestive System Diseases
  • Pharmacologic Actions
  • Digestive System Neoplasms
  • Physiological Effects of Drugs
  • Fluorouracil
  • Rectal Diseases
  • Gastrointestinal Diseases
  • Rectal Neoplasms
  • Gastrointestinal Neoplasms
  • Therapeutic Uses
  • Growth Substances
  • Vitamin B Complex
  • Immunologic Factors
  • Vitamins
  • Immunosuppressive Agents
  • Gastroenterology
  • Intestinal Diseases
  • Oncology (Adult)
  • Intestinal Neoplasms
  • Surgery (Colon and Rectal)
  • Leucovorin
 
KP Clinical Facility
  • Anaheim
  • Riverside
  • San Diego
  • San Marcos
 
Clinical Area
  • Gastroenterology
  • Oncology (Adult)
  • Surgery (Colon and Rectal)


Principal Investigator:
Gary A Bushschacher, MD
Contact Information:
- Kaiser Permanente Clinical Trials
-844-294-4114
-clinical.trials@kp.org
-Southern California


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