Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer

• Status: Recruiting
• Trial end date: 2033-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University

Criteria

Inclusion Criteria:

• 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

• Within 28 days prior to registration:

• History/physical examination

• Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis or whole-body PET-CT

• Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging

• ECOG Performance Status ≤1

• Age ≥ 18 years

• Adequate bone marrow function defined as follows:

• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

• Platelets ≥ 100,000 cells/mm3

• Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dL is acceptable.)

• Adequate liver and renal function defined as follows:

• AST and alkaline phosphatase < 2.5 x upper limit of normal (ULN)

• Bilirubin ≤ 1.5 ULN

• Calculated creatinine clearance (CrCl) > 50 mL/min using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender

• Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation

• Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy.

• WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• 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

• Within 30 days prior to registration, either of the following that would, in the opinion of the investigator, preclude study therapy:

• Chronic obstructive pulmonary disease exacerbation

• Respiratory illness requiring hospitalization

• Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects

• Major surgery within 28 days of study enrollment (other than diverting colostomy)

• History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications that would, in the opinion of the investigator, preclude study therapy

• Prior known allergic reaction to 5-FU or oxaliplatin

• Known dipyrimidine dehydrogenase deficiency (DPD)

• Any evidence of distant metastases (M1)

• Pregnant or breast feeding

• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements