Advanced Rectal CancerPhase 2NCT03781323
Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer
A Phase 2 study testing FOLFOX in people with Advanced Rectal Cancer, run by University of Rochester at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Rectal Cancer
- What is being tested?
- FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2019to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must be >18 years old at time of diagnosis
- Histologically confirmed adenocarcinoma of the rectum from biopsy, defined as adenocarcinoma <15 cm from the anal verge
- Clinical staging including T3N0 tumors, or T1-3 with N1-2a disease
- Patients with lower rectal cancer deemed by surgery to not be candidates for sphincter sparing surgery are eligible to participate
- There must be no evidence of metastatic disease any time prior to initiation of study
- Rectal tumors must be determined as likely requiring total mesorectal excision (TME)
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- Participant must be treatment naïve for rectal cancer, with no prior radiation chemotherapy, radiation, or surgery for specific rectal cancer
- No history of prior pelvic radiation
- No prior administration of platinum agents
- No active infections requiring intravenous antibiotics
- No additional active malignancy
- No prior treatment of any malignancy within the past 3 years
- Baseline lab work must meet the following parameters:
- Absolute neutrophil count (ANC)>1500/mm3
- Platelet count>100,000/mm3
- Hemoglobin>8.0 g/dL
- Total bilirubin and creatinine < 1.5x upper limit of normal (ULN)
- AST and ALT < 3x ULN
- Women of childbearing potential (WCBP) will be defined as those biologically capable of becoming pregnant. WCBP must be negative for pregnancy testing (urine or blood) and agree to use effective contraception. Viable contraception should be used after trial screening, before initiation of chemotherapy, and throughout the duration of active treatment in the study.
- Participants must be read and explained the purposes of the study, and sign a statement of informed consent prior to participation. Those who do not read or understand English are eligible and may be consented according to institutional federal regulations.
Who cannot join
- Recurrent or refractory rectal adenocarcinoma
- T1N0, T2N0, T4a, T4b, or N2b tumors
- Any evidence of metastatic disease
- Primary unresectable rectal cancer. A tumor will be considered unresectable when invading adjacent organs such that an en bloc resection cannot achieve negative margins
- Patients with threatened margins, defined as tumor <1 mm from circumferential resection margins or mesorectal fascia
- Patients unable to undergo MRI imaging
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- Patient with a history of any arterial thrombotic event within the past 6 months. This includes angina, myocardial infarction, transient ischemic attack, or cerebral vascular accident.
- Patients with history of venous thrombotic episodes such as deep vein thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Patients who are anticoagulated for atrial fibrillation or other conditions may participate only if on stable doses of anticoagulant therapy.
- Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy
- Peripheral neuropathy>grade 1 by Common Terminology Criteria for Adverse Events, or CTCAEa
- The patient must not be on any clinical trials involving other experimental therapies before or during study treatment
- Women who are currently pregnant or breast-feeding
- Men and women expecting to father/conceive children
- Patients with any other concord medical or psychiatric condition which were deemed inappropriate for entry into the study per the investigator.
- History of other invasive malignancy within the past 3 years, except for adequately treated non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ or carcinoma in situ of the cervix.
- aCTCAE version 5.0 from Department of Health and Human Services
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, 14642
University of Rochester
Rochester, New York, 14642
About this study
Official title: Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer: A Phase II Study
The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.
Read the detailed description
These patients will be evaluated for complete clinical response (cCR) after completing 10 cycles of FOLFOX (fluorouracil, leucovorin, oxaliplatin) chemotherapy, with interval analysis after six cycles. Patients who have stable or progressive disease will be treated per discretion of the treating physician following multidisciplinary discussion. Those determined to have partial or complete response will complete full neoadjuvant treatment and undergo close surveillance with watchful waiting for local recurrence without immediate surgery. The primary endpoint of this study will be the rate of cCR, which is to include complete and near complete clinical response, with secondary endpoints of disease free survival (DFS), overall survival (OS), quality of life (QOL), as well as evaluation of safety and toxicity.
- Conditions
- Advanced Rectal Cancer
- Being tested
- FOLFOX
- Keywords
- Advanced rectal cancer, FOLFOX (fluorouracil, leucovorin, oxaliplatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXDrug
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin) | Experimental | Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours. Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With a Complete Clinical Response.
- A complete response will consist of a digital rectal exam with normal appearing mucosa and sigmoidoscopy/proctoscopy with scarring but no nodularity or ulcerations.
- A near complete response will consist of digital rectal exam with smooth or minor mucosal abnormalities, and sigmoidoscopy/proctoscopy with small mucosal abnormalities, or superficial ulceration or erythematous scarring.
- Partial response, in our study, will be those tumors read with RECIST version 1.1 criteria with a ≥20% decrease in size without obtaining near or complete response.
- Stable disease, in our study, will be those tumors read with RECIST criteria with a <20% decrease in size without obtaining near or complete response.
- Progressive disease will be those tumors with >20% increase in size by RECIST version 1.1 criteria on imaging.
Measured: 1 year
Secondary outcomes (4)
Proportion of Patients With Survival
Will be measured by physical exams
Measured: 5 years
Proportion of Patients With Survival
Will be measured by laboratory testing
Measured: 5 years
Proportion of Patients With Survival
Will be measured by proctoscopy
Measured: 5 years
Proportion of Patients With Survival
Will be measured by sigmoidoscopy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start3 May 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Dunne, University of Rochester
- Investigators
- Richard Dunne, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781323
- Sponsor's protocol ID
- UGIC18095
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2018
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT03781323
- Acronym / sponsor ID
- UGIC18095
- Conditions
- Advanced Rectal Cancer
- Keywords
- Advanced rectal cancer, FOLFOX (fluorouracil, leucovorin, oxaliplatin)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 11 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery.
Detailed description
These patients will be evaluated for complete clinical response (cCR) after completing 10 cycles of FOLFOX (fluorouracil, leucovorin, oxaliplatin) chemotherapy, with interval analysis after six cycles. Patients who have stable or progressive disease will be treated per discretion of the treating physician following multidisciplinary discussion. Those determined to have partial or complete response will complete full neoadjuvant treatment and undergo close surveillance with watchful waiting for local recurrence without immediate surgery. The primary endpoint of this study will be the rate of cCR, which is to include complete and near complete clinical response, with secondary endpoints of disease free survival (DFS), overall survival (OS), quality of life (QOL), as well as evaluation of safety and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin) | Experimental | Drug: FOLFOXPatients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must be >18 years old at time of diagnosis
- Histologically confirmed adenocarcinoma of the rectum from biopsy, defined as adenocarcinoma <15 cm from the anal verge
- Clinical staging including T3N0 tumors, or T1-3 with N1-2a disease
- Patients with lower rectal cancer deemed by surgery to not be candidates for sphincter sparing surgery are eligible to participate
- There must be no evidence of metastatic disease any time prior to initiation of study
Key exclusion criteria (16 listed)
- Recurrent or refractory rectal adenocarcinoma
- T1N0, T2N0, T4a, T4b, or N2b tumors
- Any evidence of metastatic disease
- Primary unresectable rectal cancer. A tumor will be considered unresectable when invading adjacent organs such that an en bloc resection cannot achieve negative margins
- Patients with threatened margins, defined as tumor <1 mm from circumferential resection margins or mesorectal fascia
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 |
|---|---|---|
| FOLFOXPatients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle. Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours. | Drug | mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin) |
Primary outcome
Proportion of Patients With a Complete Clinical Response.
Time frame: 1 year
* A complete response will consist of a digital rectal exam with normal appearing mucosa and sigmoidoscopy/proctoscopy with scarring but no nodularity or ulcerations. * A near complete response will consist of digital rectal exam with smooth or minor mucosal abnormalities, and sigmoidoscopy/proctoscopy with small mucosal abnormalities, or superficial ulceration or erythematous scarring. * Partial response, in our study, will be those tumors read with RECIST version 1.1 criteria with a ≥20% decrease in size without obtaining near or complete response. * Stable disease, in our study, will be those tumors read with RECIST criteria with a <20% decrease in size without obtaining near or complete response. * Progressive disease will be those tumors with >20% increase in size by RECIST version 1.1 criteria on imaging.
4 secondary outcomes
Proportion of Patients With Survival
Time frame: 5 years
Proportion of Patients With Survival
Time frame: 5 years
Proportion of Patients With Survival
Time frame: 5 years
Proportion of Patients With Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Richard Dunne principal investigator
University of Rochester
2 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 FOLFOX in people with Advanced Rectal Cancer, run by University of Rochester at 2 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 20 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 11 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With a Complete Clinical Response. (time frame: 1 year). 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 4 Jun 2026.