New combo therapy aims to boost rectal cancer survival
NCT ID NCT04643366
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This phase 2 trial is testing a two-month course of chemotherapy (mFOLFOX) followed by short-course radiation before surgery for people with resectable rectal cancer. The goal is to see if this approach improves the chance of being cancer-free three years later. About 54 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (oxaliplatin, 5-fluorouracil, leucovorin) and radiation therapy
- What this could lead to
- If successful, this approach could improve the chance of being cancer-free three years after treatment for people with resectable rectal cancer.
- What could go wrong
- This is a small, early-phase trial (54 participants) with no control group, so results may not apply broadly. Chemotherapy and radiation have side effects like fatigue, nausea, and bowel issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VCU Community Memorial Healthcenter
RECRUITINGSouth Hill, Virginia, 23970, United States
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VCU Health Tappahannock Hospital
NOT_YET_RECRUITINGTappahannock, Virginia, 22560, United States
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Virginia Cancer Institute
RECRUITINGRichmond, Virginia, 23230, United States
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Virginia Commonwealth University Massey Cancer Center
RECRUITINGRichmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase II study of total neoadjuvant mFOLFOX6 plus suvemcitug and enlonstobart with selective omission of pelvic radiotherapy for High-Risk Mid-Rectal locally advanced rectal cancer with MSS status
- Leveraging digital health solutions to collect Patient-Reported outcomes in rectal cancer
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can Pre-Surgery radiation stop rectal cancer from returning?
- Can a platform trial match the right drug combo to each tumor?
- Laser light may help surgeons spot risky bowel connections