Rectal AdenocarcinomaEarly Phase 1NCT05108428
Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma
A Early Phase 1 study testing Capecitabine, Radiation Therapy and FOLFOX regimen in people with Rectal Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine the feasibility of using magnetic resonance imaging (MRI)-guided adaptive chemoradiation therapy to improve response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Capecitabine, Radiation Therapy and FOLFOX regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2021to Oct 2026
- Phase
- Early Phase 1
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1
- Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- Clinical Stage II or III as determined on rectal MRI with a distal tumor extent/margin no more than 1 cm proximal to the anterior peritoneal reflection.
- Must have the ability to swallow and retain oral medications
- Adequate hematologic function within 28 days before registration as defined in protocol.
- Adequate hepatic function within 45 days before registration, as defined in protocol.
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- Adequate renal function within 28 days before registration, as defined in protocol.
- International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before registration must be within normal limits for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history
- Pregnancy test done within 14 days before registration must be negative (for women of childbearing potential only). Pregnancy testing should be performed according to institutional standards.
Who cannot join
- Patients with one or more of the following conditions are NOT eligible for this study:
- Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, mixed adenoneuroendocrine, anal adenocarcinoma, etc.).
- History of prior invasive rectal malignancy, regardless of disease-free interval or history of familial polyposis syndrome (Lynch, FAP, etc.).
- Patients with a history of antineoplastic treatment for prior malignancy within the past 3 years, except for adequately treated basal cell skin carcinoma or in situ cervical cancer. Note: Hormone therapy for breast cancer is permitted.
- Primary unresectable rectal cancer. Note: A tumor is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins.
- Synchronous colorectal adenocarcinomas.
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- Tumor may not be causing symptomatic bowel obstruction
- Definitive clinical or radiologic evidence of metastatic disease or nodal disease outside of the prescribed radiation field. Note: Required imaging studies must have been performed within 28 days prior to enrollment.
- Patients with a history of an arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction, transient ischemic attack (TIA), Cardiovascular Accident (CVA). Note: Patients with a history of venous thrombotic episodes such as deep venous 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. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
- No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matric metalloprotease inhibitors, thalidomide, anti-VEGF (vascular endothelial growth factor) monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
- Inflammatory bowel disease or have a history of abdominal surgery that may interfere with gastrointestinal motility or absorption.
- Ineligibility to undergo MR imaging or treatment on the MRL due to medical or physical reasons. Anxiety disorders will be permitted if pre-medicated with anxiolytics.
- Active seizure disorder uncontrolled by medication.
- Major surgery within 12 weeks before enrollment.
- Any prior pelvic radiation.
- Known DPD (dihydro pyrimidine dehydrogenase) deficiency. Any of the following because this study involves agents that have known or potential genotoxic or mutagenic and teratogenic effects: Pregnant women, Nursing women who are unwilling to discontinue nursing, Men or women of childbearing potential who are unwilling to employ adequate contraception (e.g. hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 3 months after the last dose of study therapy.
- Any diagnosis of acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease.
- Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up.
- BMI > 40 is considered exclusive from this study due to increased surgical complication risk and greater risk of incomplete resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI Guided Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma to Enhance Complete Response
The purpose of the study is to determine the feasibility of using magnetic resonance imaging (MRI)-guided adaptive chemoradiation therapy to improve response to treatment.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Capecitabine, Radiation Therapy, FOLFOX regimen
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Capecitabine 825 mg/m^2 twice daily orally 5 days per week on days of planned radiation therapy.
Radiation TherapyRadiation
Participants will receive varying doses of radiotherapy based on MRI guidance, beginning at 28-33 fractions (1.8 Gray units) .
FOLFOX regimenDrug
Standard of Care FOLFOX regimen consists of 8 cycles (each cycle is 14 days) of 5-fluorouracil, leucovorin, and oxaliplatin. Dosage is as follows: Oxaliplatin 85 mg/m^2 IV over 2 hours day 1 each cycle. Leucovorin (optional) 400 mg/m^2 IV over 2 hours day 1 each cycle. 5-fluorouracil bolus* (optional) 400 mg/m^2 IV push day 1 of each cycle, and 5-fluorouracil infusion 2400 mg/m^2 IV continuous infusion over 46 hours day 1 each cycle.
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided adaptive radiation | Experimental | Patients will receive capecitabine-based chemoradiotherapy (chemotherapy with capecitabine + radiation). Dosing will be modified based on tumor changes measured daily and weekly by MR-guided radiotherapy (MRgRT) utilizing MR-linac (MRL) systems. Chemoradiotherapy will be followed by standard of care consolidated chemotherapy. (FOLFOX) Receives: Drug: Capecitabine; Radiation: Radiation Therapy; Drug: FOLFOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MRI guided dose adaptive chemoradiation therapy
Investigators will demonstrate if MRI guided dose-adaptation based on MR morphologic objective measurements during primary chemoradiation is feasible. Feasibility will be recorded for each patient as an indicator variable (1=feasible; 0=not feasible)
Measured: Up to 6 weeks
Secondary outcomes (2)
Number of Participants with Complete Clinical Response (cCR)
Complete Clinical Response is defined as the absence of clinically detectable tumor after treatment.
Measured: Up to 6 months
Number of Participants with Pathological Complete Response (pCR)
Pathological Complete Response (pCR) is defined as the lack of all signs of cancer in tissue samples after treatment.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start23 Dec 2021
- Primary completion9 Oct 2023
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Viewray Inc., Natera, Inc.
- Responsible party
- Sponsor
- Investigators
- Jessica M Frakes, MD, Principal investigator, Moffitt Cancer CenterSeth Felder, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108428
- Sponsor's protocol ID
- MCC-20911
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2021
- Last updated
- 1 Apr 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Guided Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma to Enhance Complete Response
- ClinicalTrials.gov ID
- NCT05108428
- Acronym / sponsor ID
- MCC-20911
- Conditions
- Rectal Adenocarcinoma
- Keywords
- colon cancer, rectal cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Viewray Inc., Natera, Inc.
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Nov 2021 (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.
The purpose of the study is to determine the feasibility of using magnetic resonance imaging (MRI)-guided adaptive chemoradiation therapy to improve response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided adaptive radiation | Experimental | Drug: Capecitabine, Radiation: Radiation Therapy, Drug: FOLFOX regimenPatients will receive capecitabine-based chemoradiotherapy (chemotherapy with capecitabine + radiation). Dosing will be modified based on tumor changes measured daily and weekly by MR-guided radiotherapy (MRgRT) utilizing MR-linac (MRL) systems. Chemoradiotherapy will be followed by standard of care consolidated chemotherapy. (FOLFOX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1
- Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- Clinical Stage II or III as determined on rectal MRI with a distal tumor extent/margin no more than 1 cm proximal to the anterior peritoneal reflection.
- Must have the ability to swallow and retain oral medications
- Adequate hematologic function within 28 days before registration as defined in protocol.
Key exclusion criteria (19 listed)
- Patients with one or more of the following conditions are NOT eligible for this study:
- Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, mixed adenoneuroendocrine, anal adenocarcinoma, etc.).
- History of prior invasive rectal malignancy, regardless of disease-free interval or history of familial polyposis syndrome (Lynch, FAP, etc.).
- Patients with a history of antineoplastic treatment for prior malignancy within the past 3 years, except for adequately treated basal cell skin carcinoma or in situ cervical cancer. Note: Hormone therapy for breast cancer is permitted.
- Primary unresectable rectal cancer. Note: A tumor is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins.
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 |
|---|---|---|
| CapecitabineAlso: XelodaCapecitabine 825 mg/m^2 twice daily orally 5 days per week on days of planned radiation therapy. | Drug | MRI-guided adaptive radiation |
| Radiation TherapyParticipants will receive varying doses of radiotherapy based on MRI guidance, beginning at 28-33 fractions (1.8 Gray units) . | Radiation | MRI-guided adaptive radiation |
| FOLFOX regimenStandard of Care FOLFOX regimen consists of 8 cycles (each cycle is 14 days) of 5-fluorouracil, leucovorin, and oxaliplatin. Dosage is as follows: Oxaliplatin 85 mg/m^2 IV over 2 hours day 1 each cycle. Leucovorin (optional) 400 mg/m^2 IV over 2 hours day 1 each cycle. 5-fluorouracil bolus* (optional) 400 mg/m^2 IV push day 1 of each cycle, and 5-fluorouracil infusion 2400 mg/m^2 IV continuous infusion over 46 hours day 1 each cycle. | Drug | MRI-guided adaptive radiation |
Primary outcome
Feasibility of MRI guided dose adaptive chemoradiation therapy
Time frame: Up to 6 weeks
Investigators will demonstrate if MRI guided dose-adaptation based on MR morphologic objective measurements during primary chemoradiation is feasible. Feasibility will be recorded for each patient as an indicator variable (1=feasible; 0=not feasible)
2 secondary outcomes
Number of Participants with Complete Clinical Response (cCR)
Time frame: Up to 6 months
Number of Participants with Pathological Complete Response (pCR)
Time frame: Up to 6 months
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 Apr 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. This study is not recruiting at the moment.
Jessica M Frakes, MD principal investigator
Moffitt Cancer Center
Seth Felder, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Capecitabine, Radiation Therapy and FOLFOX regimen in people with Rectal Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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 9 inclusion and 19 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Feasibility of MRI guided dose adaptive chemoradiation therapy (time frame: Up to 6 weeks). 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 Apr 2026.