Rectal CancerPhase 2NCT04643366
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer
A Phase 2 study testing Chemotherapy and Radiation Therapy in people with Rectal Cancer, run by Virginia Commonwealth University at 4 sites in United States.
Trial summary
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Chemotherapy and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jan 2021to 31 Jan 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23230
Sue Moore, MSN, RN, 804-287-3000 ext. 1261, smoore@vacancer.com
Purvi Shah, MD
- Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
Massey CTO GI Team, RN, 804-628-6430, masseygi@vcu.edu
Khalid Matin, MD
- Recruiting
VCU Community Memorial Healthcenter
South Hill, Virginia, 23970
Massey CTO GI Team, 804-628-6430, masseygi@vcu.edu
Khalid Matin, MD
- Not yet recruiting
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560
Massey CTO GI Team, 804-628-6430, masseygi@vcu.edu
Khalid Matin, MD
About this study
Official title: Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Read the detailed description
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).
- Conditions
- Rectal Cancer
- Being tested
- Chemotherapy, Radiation Therapy
- Keywords
- Resectable, Rectal
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)
Radiation TherapyRadiation
Pelvic Intensity-modulated radiation therapy (IMRT)
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Chemotherapy/ Radiation Therapy | Experimental | 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. Receives: Drug: Chemotherapy; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year disease free survival (DFS)
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).
Measured: 3 years after end of treatment
Secondary outcomes (6)
Pathologic complete response (pCR) rate
The number of patients that achieve pathologic complete response(pCR)(defined as negative surgical margins and no evidence of residual viable tumor) at time of total mesorectal excision (TME).
Measured: 3 Years after end of treatment
Clinical complete response (cCR) following total neoadjuvant therapy (TNT) based on tumor response
Determine the cCR using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), in patients evaluable for response
Measured: 3 Years after end of treatment
The number of Adverse events (AEs) per participant
The number of Adverse events (AEs) per participant characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v. 5.0)
Measured: 39 Months
Progression (PFS) Rate
PFS defined as the time from initiation of chemotherapy until date of progression
Measured: 3 Years and 5 years after end of treatment
Overall Survival (OS) Rate
OS defined as the time from initiation of chemotherapy until death by any cause.
Measured: 5 Years after end of treatment
Number of patients who do not require an ostomy at time of surgery
After neoadjuvant therapy is complete patients will undergo assessment of disease status prior to determination of whether they will proceed to surgical resection or active surveillance
Measured: 116 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start28 Jan 2021
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khalid Matin, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643366
- Sponsor's protocol ID
- MCC-18-14260
- Other IDs
- HM20020384, NCI-2020-13796
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer
- ClinicalTrials.gov ID
- NCT04643366
- Acronym / sponsor ID
- MCC-18-14260
- Conditions
- Rectal Cancer
- Keywords
- Resectable, Rectal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Chemotherapy/ Radiation Therapy | Experimental | Drug: Chemotherapy, Radiation: Radiation Therapy5-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyNeoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX) | Drug | Concurrent Chemotherapy/ Radiation Therapy |
| Radiation TherapyPelvic Intensity-modulated radiation therapy (IMRT) | Radiation | Concurrent Chemotherapy/ Radiation Therapy |
Primary outcome
Three-year disease free survival (DFS)
Time frame: 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).
6 secondary outcomes
Pathologic complete response (pCR) rate
Time frame: 3 Years after end of treatment
Clinical complete response (cCR) following total neoadjuvant therapy (TNT) based on tumor response
Time frame: 3 Years after end of treatment
The number of Adverse events (AEs) per participant
Time frame: 39 Months
Progression (PFS) Rate
Time frame: 3 Years and 5 years after end of treatment
Overall Survival (OS) Rate
Time frame: 5 Years after end of treatment
Number of patients who do not require an ostomy at time of surgery
Time frame: 116 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khalid Matin, MD principal investigator
Massey Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy and Radiation Therapy in people with Rectal Cancer, run by Virginia Commonwealth University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey IIT Research Operations, RN (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-year disease free survival (DFS) (time frame: 3 years after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.