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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Standard of care chemotherapy with the change for avoidance of extensive surgery

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: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa C Miller, BA; Phone Number: 313-343-3166; Email: lisa.miller4@ascension.org
• Study Contact Backup: Name: Susan M Szpunar, PhD; Phone Number: 313-343-7838; Email: susan.szpunar@ascension.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Recruiting
      • Ascension St. John Hospital
      • Contact: Lisa C. Miller, BA; Phone Number: 313-343-3166; Email: lisa.miller@ascension.org
      • Contact: Amr Aref, MD; Phone Number: 313-343-3166; Email: amr.aref@ascension.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete remission	Percent of patients who achieve complete remission	18 months
Partial remission	Percent of patients who achieve partial remission	18 months
Disease progression	Percent of patients with disease progression	18 months
Local resection	Percent of patients who require local resection only	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient quality of life	Quality of life score on questionnaire	18 months
Patient health status	Patient self-reported health status	18 months

Collaborators and Investigators

• Sponsor: Ascension South East Michigan
• Investigators: Principal Investigator: Amr Aref, MD, Ascension SME

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2016
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: May 5, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 866142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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