Clinical trial NCT03941366: Treatment of Adenocarcinoma of the Rectum With Transanal Local Excision for Complete Responders
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients in the trial receive the intervention and are followed prospectively.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete remission
timeFrame: 18 months
measure: Partial remission
timeFrame: 18 months
measure: Disease progression
timeFrame: 18 months
measure: Local resection
timeFrame: 18 months
Secondary outcomes:
measure: Patient quality of life
timeFrame: 18 months
measure: Patient health status
timeFrame: 18 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
Study officials:
affiliation: Ascension SME
name: Amr Aref, MD
role: PRINCIPAL_INVESTIGATOR
References: