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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03941366

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

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:Rectal Cancer
  • Intervention/Treatment: Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 15 participants
  • 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 2016
  • Estimated Primary Completion Date: January 2025
  • Estimated Study Completion Date: January 2025
Arms and interventions
Arm Intervention/treatment
Other: 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.
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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

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

Contacts and Locations

Contact: Lisa C Miller, BA 313-343-3166 lisa.miller4@ascension.org

Contact: Susan M Szpunar, PhD 313-343-7838 susan.szpunar@ascension.org


United States, Michigan
Ascension St. John Hospital

Sponsors and Collaborators

Ascension South East Michigan

More Information
  • Responsible Party: Ascension South East Michigan
  • ClinicalTrials.gov Identifier: NCT03941366 History of Changes
  • 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
  • Plan to Share IPD: No
  • 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.: Yes
  • Additional relevant MeSH terms: Adenocarcinoma