US University is about to start new clinicl trial of Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer

Virginia Commonwealth University is enrolling patients into the clinical trial investigating Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer.

This trial involves 4 cycles of systemic chemotherapy followed by short-course RT with concurrent 5-FU neoadjuvant chemoradiotherapy (CRT) and subsequent consolidation with 4 cycles of systemic chemotherapy prior to surgery or, for those who achieve cCR, the option of non-operative active surveillance.Three-year disease free survival (DFS) defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).

The trial is designed to enroll male and female 18 years and older and is being conducted in the Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States.

The indicators for inclusion are:

  • Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy.
  • Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup: Colonoscopy within 90 days prior to registration.

There are other inclusion criteria.

The indicators for exclusion are:

  • Prior RT that would result in overlap of RT fields with the planned study treatment.
  • Clinically significant cardiac disease, including major cardiac dysfunction, such as uncontrolled angina, clinical congestive heart failure with New York Heart Association (NYHA) class III or IV, ventricular arrhythmias requiring anti-arrhythmic therapy, recent (within the last 6 months) myocardial infarction, or unstable disease.
  • Serious (ie, ≥ grade 3) uncontrolled infection.

There are other exclusion criteria.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04643366

Clinical Research News

Upcoming Clinical Trials

3