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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941366
• Other study ID #: 866142
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2016
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2023
• Source: Ascension South East Michigan
• Contact: Lisa C Miller, BA
• Phone: 313-343-3166
• Email: lisa.miller4[@]ascension.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Ascension St. John Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission	Percent of patients who achieve complete remission	18 months
Primary	Partial remission	Percent of patients who achieve partial remission	18 months
Primary	Disease progression	Percent of patients with disease progression	18 months
Primary	Local resection	Percent of patients who require local resection only	18 months
Secondary	Patient quality of life	Quality of life score on questionnaire	18 months
Secondary	Patient health status	Patient self-reported health status	18 months