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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03941366
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
Amr Aref, Ascension South East Michigan

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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
Official Title: 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
Actual Study Start Date : February 26, 2016
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. Complete remission [ Time Frame: 18 months ]
    Percent of patients who achieve complete remission

  2. Partial remission [ Time Frame: 18 months ]
    Percent of patients who achieve partial remission

  3. Disease progression [ Time Frame: 18 months ]
    Percent of patients with disease progression

  4. Local resection [ Time Frame: 18 months ]
    Percent of patients who require local resection only

Secondary Outcome Measures :
  1. Patient quality of life [ Time Frame: 18 months ]
    Quality of life score on questionnaire

  2. Patient health status [ Time Frame: 18 months ]
    Patient self-reported health status

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03941366

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Contact: Lisa C Miller, BA 313-343-3166
Contact: Susan M Szpunar, PhD 313-343-7838

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United States, Michigan
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Lisa C. Miller, BA    313-343-3166   
Contact: Amr Aref, MD    313-343-3166   
Sponsors and Collaborators
Ascension South East Michigan
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Responsible Party: Amr Aref, Director, Radiation Oncology, Ascension South East Michigan Identifier: NCT03941366    
Other Study ID Numbers: 866142
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type