Total Neoadjuvant Therapy for Resectable Rectal Cancer
This study is looking at a new way to treat rectal cancer that can be removed with surgery. It combines chemotherapy (mFOLFOX, which includes oxaliplatin and 5-Fluorouracil) with short-course radiation therapy. You might be able to join if you have been diagnosed with adenocarcinoma of the rectum within the last 90 days, and your tumor is located in a specific area. The main goal of this study is to see how many people are free of their cancer three years after treatment. The study plans to enroll 64 participants, but its current status is unclear.
- Study design
- This is a Phase 2 interventional study, meaning it tests a new treatment approach in a group of people. It plans to enroll 64 participants.
- What's involved
- You would receive 4 cycles of chemotherapy, followed by short-course radiation therapy with concurrent 5-FU, and then 4 more cycles of chemotherapy before surgery. Some participants might have the option of active surveillance instead of surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your disease-free survival will be measured at 3 years after the end of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04643366
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentVirginia Commonwealth UniversityInvestigator-initiated
~64 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:ChemotherapyRadiation Therapy
At a glance
Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Three-year disease free survival (DFS)
Measured over 3 years after end of treatment
Conditions
Where it's being run
4 sites across 1 statesVirginia4
Study leadership
- Khalid Matin, MD · PRINCIPAL_INVESTIGATOR · Massey Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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, unless patient presents with an obstructing lesion
Within 30 days before initiating MFOLFOX6 treatment:
History/physical examination
Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis; or whole-body PET-CT; or MRI
Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging Note: Patients may have initiated standard mFOLFOX6 treatment before study registration provided that they met the above criteria before initiating treatment and can feasibly continue to CRT according to the timeline described in Section
ECOG Performance Status ≤2
Age ≥ 18 years
Adequate bone marrow function defined as follows:
Absolute neutrophil count (ANC) ≥ 1,200 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 ≤ 2.5 ULN
Calculated creatinine clearance (CrCl) \> 30 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
Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist
Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.
Serious (ie, ≥ grade 3) uncontrolled infection
Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.
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-fluorouracil, leucovorin, 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
What this trial measures
- Three-year disease free survival (DFS)3 years after end of treatment
The three-year disease free survival (DFS) defined as the number 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).