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Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders

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ClinicalTrials.gov Identifier: NCT03941366
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Aref, Ascension South East Michigan

Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE February 26, 2016
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Complete remission [ Time Frame: 18 months ]
    Percent of patients who achieve complete remission
  • Partial remission [ Time Frame: 18 months ]
    Percent of patients who achieve partial remission
  • Disease progression [ Time Frame: 18 months ]
    Percent of patients with disease progression
  • Local resection [ Time Frame: 18 months ]
    Percent of patients who require local resection only
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Patient quality of life [ Time Frame: 18 months ]
    Quality of life score on questionnaire
  • Patient health status [ Time Frame: 18 months ]
    Patient self-reported health status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
Official Title  ICMJE Treatment of T2-T3/NO-N+ Adenocarcinoma of the Rectum by Neoadjuvant Chemotherapy (FOLFOX) Followed by Preoperative Chemo (5FU/Capecitabine)-Radio Therapy (CRT) With Transanal Local Excision for Complete Responders
Brief Summary The current standard of care for rectal cancer has diminished local recurrence and enhanced survival. Quality of life, however, remains poor for many patients and the probability of distant recurrence is high. In this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.
Detailed Description

The purpose of the study is to determine if neo-adjuvant FOLFOX therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission.

This is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant FOLFOX chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life.

All procedures in this study are standard of care, the study question relates to the use of neo-adjuvant FOLFOX and the timing between the end of radiation and surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All patients in the trial receive the intervention and are followed prospectively.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery
All treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery.
Study Arms  ICMJE Neoadjuvant Chemotherapy and Follow-up Surgery
All patients will receive standard of care therapy and based upon their response will either receive transanal local resection or full resection, based on pathologic response.
Intervention: Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Diagnosis of rectal invasive adenocarcinoma
  3. Tumor in the low or mid rectum (up to 11 cm from the anal verge)
  4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible.

1. Clinical staging will be estimated based on the combination of the following assessments:

  1. Physical examination by the primary surgeon
  2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis
  3. Pelvic MRI and endoscopic ultrasound

Exclusion Criteria:

  • Less than 18 years of age
  • Do not complete informed consent
  • Pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa C Miller, BA 313-343-3166 lisa.miller4@ascension.org
Contact: Susan M Szpunar, PhD 313-343-7838 susan.szpunar@ascension.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941366
Other Study ID Numbers  ICMJE 866142
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amr Aref, Ascension South East Michigan
Study Sponsor  ICMJE Ascension South East Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ascension South East Michigan
Verification Date May 2019

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