Rectal CancerPhase 1NCT04677413
Ultra-fractionated Radiotherapy for Rectal Cancer
A Phase 1 study testing Ultrafractionated radiotherapy for rectal cancer in people with Rectal Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. 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?
- Ultrafractionated radiotherapy for rectal cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to Jun 2027
- Phase
- 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
- At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
- Willing and able to provide written informed consent
- Pathologic diagnosis of rectal adenocarcinoma
- T3-4 and/or N+ disease per AJCC 8th edition
- No prior treatment for rectal adenocarcinoma
- Eastern Cooperative Group (ECOG) performance status of 0-2.
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- Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows:
- WBC ≥ 3,000/mL;
- ANC WBC ≥ 1,000/mL;
- PLT ≥ 75,000/mL;
- T Bili ≤ 1.5 x upper limit of normal (ULN);
- AST/ALT ≤ 2.5 x ULN;
- Creatinine not above ULN, or creatinine clearance >50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal.
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
- Prior RT to the pelvis.
- Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
- Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
- Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-8849
About this study
Official title: Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
Read the detailed description
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or CAPOX (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.
- Conditions
- Rectal Cancer
- Being tested
- Ultrafractionated radiotherapy for rectal cancer
- Keywords
- Rectal Cancer,T3-4 or N+
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrafractionated radiotherapy for rectal cancerRadiation
To determine the toxicity of dose-escalated hypofractionated RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX or CAPOX chemotherapy and selective omission of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Cohorts | Experimental | DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis)
DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis) Receives: Radiation: Ultrafractionated radiotherapy for rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
The MTD will be based upon toxicity, which will be assessed according to the NCI's CTCAE v5.0 toxicity criteria. Dose limiting toxicities will include any of the following Grade 3+ GI toxicities.
Measured: 0 to 60 days post radiation therapy
Secondary outcomes (6)
To evaluate the rate of clinical complete and near complete response to radiation and chemotherapy.
Clinical complete response, assessed at 4-8 weeks after completion of chemotherapy and radiation, will be defined based upon endoscopy and MRI as described in section 4.1.1.
Measured: 1 year
To determine the organ preservation rate at 1 year after radiotherapy and FOLFOX or CAPOX chemotherapy.
Organ preservation rate will be defined as rate of intact rectum and no local regional failure at 1 year from completion of treatment.
Measured: 1 year
To evaluate local regional recurrence, defined as the time between date of therapy initiation and date of local progression.
The rate of local regional recurrence will be defined as disease recurrence in the pelvis and will be recorded on a time interval since completion of treatment. This will be evaluated as a median and rate up to 1 year post treatment. The time will be backdated to when the recurrence was observed.
Measured: 1 year
To evaluate disease-free survival (DFS), defined as the time between date of therapy completion the first date of documented disease progression or death.
The disease-free survival endpoint will be defined as the percent of patients without disease recurrence at 1-year.
Measured: 1 year
For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.
R0 resection will be defined by the percent of patients with an R0 resection or negative surgical margin at the time of total mesorectal excision. Acute and late toxicities will be recorded as the rate of treatment related grade 3-5 adverse events experienced in the acute phase from initiation of therapy to 6 weeks treatment to the late phase 6 weeks to 1 year, using the NCI's CTCAE v5.0 toxicity criteria.
Measured: 1 year
To evaluate the rate of distant failure, defined as development of disease outside of the pelvis.
The rate of distant failure will be recurrence of disease outside of the pelvis that will be collected on time interval since completion of therapy and be evaluated as a median or rate up to 1-year follow-up. Time will be backdated to when the recurrence was observed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start3 Jun 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 University of Texas Southwestern Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective dose evaluation
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Sanford, University of Texas Southwestern Medical Center
- Investigators
- Nina Sanford, MD, Principal investigator, UT SOUTHWESTERN medical CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677413
- Sponsor's protocol ID
- 2020-1394
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04677413
- Acronym / sponsor ID
- 2020-1394
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer,T3-4 or N+
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Dec 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.
The rationale of this clinical trial is to assess the feasibility of selective non-operative management for locally advanced rectal cancer using dose-escalated ultra-fractionated short course radiation therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy over a prolonged interval, at escalated doses and with concurrent chemotherapy may be feasible and allow for improved clinical response.
Detailed description
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated adaptive RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX (5-FU, oxaliplatin, leucovorin) or CAPOX (capecitabine, oxaliplatin) chemotherapy and selective omission of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective dose evaluation
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Cohorts | Experimental | Radiation: Ultrafractionated radiotherapy for rectal cancerDOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis) DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis) DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
- Willing and able to provide written informed consent
- Pathologic diagnosis of rectal adenocarcinoma
- T3-4 and/or N+ disease per AJCC 8th edition
- No prior treatment for rectal adenocarcinoma
Key exclusion criteria (5 listed)
- Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT.
- Prior RT to the pelvis.
- Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
- Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
- Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
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 |
|---|---|---|
| Ultrafractionated radiotherapy for rectal cancerTo determine the toxicity of dose-escalated hypofractionated RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX or CAPOX chemotherapy and selective omission of surgery. | Radiation | Phase I Dose Cohorts |
Primary outcome
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.
Time frame: 0 to 60 days post radiation therapy
The MTD will be based upon toxicity, which will be assessed according to the NCI's CTCAE v5.0 toxicity criteria. Dose limiting toxicities will include any of the following Grade 3+ GI toxicities.
6 secondary outcomes
To evaluate the rate of clinical complete and near complete response to radiation and chemotherapy.
Time frame: 1 year
To determine the organ preservation rate at 1 year after radiotherapy and FOLFOX or CAPOX chemotherapy.
Time frame: 1 year
To evaluate local regional recurrence, defined as the time between date of therapy initiation and date of local progression.
Time frame: 1 year
To evaluate disease-free survival (DFS), defined as the time between date of therapy completion the first date of documented disease progression or death.
Time frame: 1 year
For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.
Time frame: 1 year
To evaluate the rate of distant failure, defined as development of disease outside of the pelvis.
Time frame: 1 year
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 24 Jul 2026.
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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.
Nina Sanford, MD principal investigator
UT SOUTHWESTERN medical CENTRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultrafractionated radiotherapy for rectal cancer in people with Rectal Cancer, run by University of Texas Southwestern Medical Center 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 17 inclusion and 5 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 24 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 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT. (time frame: 0 to 60 days post radiation therapy). 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 24 Jul 2026.