Recruiting

Phase 2

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

Sponsor:

Virginia Commonwealth University

Code:

NCT04643366

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Radiation Therapy

Study Details

Brief summary:

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

Conditions

Rectal Cancer

Study ID

NCT04643366

Start date

Jan 28, 2021

Status verified date

Jun, 2026

Completion date

Jan 31, 2032

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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, 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 Criteria:

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

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Concurrent Chemotherapy/ Radiation Therapy

5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) four 14-day cycles will be given before CRT starts. Pelvic Intensity-modulated radiation therapy (IMRT): 25 Gy in 5 fractions over 5 days + Continuous infusion 5-fluorouracil (5-FU) for 4 days (96 hours) followed by four 14-day cycles of (mFOLFOX6) to be given after CRT ends.

Interventions

Chemotherapy

Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)

Radiation Therapy

Pelvic Intensity-modulated radiation therapy (IMRT)

Primary outcome measure

Three-year disease free survival (DFS) [ Time Frame: 3 years after end of treatment ]

Central Contacts and Locations

Central contacts

Massey IIT Research Operations, RN

804-628-6430 masseyepd@vcu.edu

Locations

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Sue Moore, MSN, RN

804-287-3000 smoore@vacancer.com

Principal Investigator:

Purvi Shah, MD

Virginia Commonwealth University Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Massey CTO GI Team, RN

804-628-6430 masseygi@vcu.edu

Principal Investigator:

Khalid Matin, MD

VCU Community Memorial Healthcenter

Recruiting

South Hill, Virginia, United States, 23970

Contacts

Massey CTO GI Team

804-628-6430 masseygi@vcu.edu

Principal Investigator:

Khalid Matin, MD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

Resectable
Rectal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-07-01.