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Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060007
First Posted: February 1, 2010
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
January 28, 2010
February 1, 2010
January 23, 2015
February 10, 2015
March 8, 2017
November 2009
April 2013   (Final data collection date for primary outcome measure)
  • Rate of T Stage Downstaging [ Time Frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) ]
    T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
  • Preoperative Gastrointestinal Morbidity [ Time Frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) ]
    As measured by participants who experience grade 3 or higher gastrointestinal morbidity
Demonstrate that short course preoperative radiotherapy followed by preoperative chemotherapy will elicit a rate of T stage downstaging comparable to or better than seen with concurrent prolonged course preoperative radiotherapy and chemotherapy. [ Time Frame: 10 weeks ]
Complete list of historical versions of study NCT01060007 on ClinicalTrials.gov Archive Site
  • Incidence of Any Late Grade 3 or Higher Morbidity [ Time Frame: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks) ]
  • Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity [ Time Frame: 1 year (completion of all treatment) ]
  • Local Control [ Time Frame: 30 months ]
    • Kaplan-Meier projections
    • Local control = control of primary tumor
  • Rate of Overall Control [ Time Frame: 1 year ]
  • Rate of Locoregional Control [ Time Frame: 1 year ]
  • Freedom From Disease Relapse [ Time Frame: 30 months ]
    Kaplan-Meier projections.
  • Determine Quality of Anorectal Function [ Time Frame: Up to 1 year ]
    Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much.
Demonstrate that short course preoperative radiotherapy followed by preoperative chemotherapy will lead to acute gastrointestinal morbidity comparable to or better than seen with concurrent prolonged course preoperative radiotherapy and chemotherapy. [ Time Frame: 10 weeks ]
Not Provided
Not Provided
 
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
Our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. If we can establish a T stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase III trial. The long-term goal is improved overall control of disease by delivering better chemotherapy earlier.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rectal Neoplasms
  • Radiation: External beam radiation
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Drug: Leucovorin
  • Drug: 5-FU
    Other Names:
    • Fluorouracil
    • Efudex
  • Drug: Capecitabine
    Other Name: Xeloda
Experimental: Neoadjuvant radiation followed by FOLFOX

Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.

FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).

If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.

Interventions:
  • Radiation: External beam radiation
  • Drug: Oxaliplatin
  • Drug: Leucovorin
  • Drug: 5-FU
  • Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2014
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Biopsy proven adenocarcinoma of the rectum
  • Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible—provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
  • Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
  • Karnofsky Performance Status at >60
  • Laboratory criteria:
  • Absolute neutrophil count >= 1.5 K
  • Platelets >= 100 K
  • Total Bilirubin <= 2.0;
  • SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
  • Creatinine < 2.0
  • Hemoglobin >= 8.0
  • Informed consent signed
  • Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies.
  • Estimated longevity at least 12 months
  • Patients with distant metastatic disease will be eligible if they satisfy all other conditions

Exclusion Criteria:

  • Pregnant women, children < 18 years, or patients unable to give informed consent
  • Patients with a past history of pelvic radiotherapy.
  • Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
  • Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
  • Prior chemotherapy for colorectal cancer.
  • Grade >= 2 peripheral neuropathy
  • Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01060007
09-0696 / 201106272
No
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
Washington University School of Medicine
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP