Adenocarcinoma of the Lower RectumNOM-ERANCT03904043
Non-Operative Management and Early Response Assessment in Rectal Cancer
A study testing Radiation therapy, FOLFOX regimen and CAPOX regimen in people with Adenocarcinoma of the Lower Rectum, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Lower Rectum
- What is being tested?
- Radiation therapy, FOLFOX regimen and CAPOX 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
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2020to 25 Jan 2026
- Phase
- Interventional
- 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
- Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI
- Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
- Clinically detectable (MR, endoscopy, or DRE) tumor present
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- At least 18 years of age
- Adequate bone marrow function defined as:
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- Absolute neutrophil count (ANC) > 1,500 cells/mm3
- Hemoglobin> 8 g/dl
- Platelets >100,000 cells/mm3
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
Who cannot join
- Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
- Prior oxaliplatin or capecitabine use for any malignancy
- No prior radiation therapy to the pelvis.
- A history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Currently receiving any investigational agents.
- A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5FU, oxaliplatin, or leucovorin.
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
- Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado
Aurora, Colorado, 80045
University of Vermont Medical Center
Burlington, Vermont, 05401
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.
- Conditions
- Adenocarcinoma of the Lower Rectum
- Being tested
- Radiation therapy, FOLFOX regimen, CAPOX regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
-Monday-Friday treatment is strongly recommended
FOLFOX regimenDrug
-CAPOX can be given as alternative
CAPOX regimenDrug
Given as an alternative to FOLFOX
| Study group | Role | What they receive |
|---|---|---|
| Radiation + FOLFOX | Experimental | * Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted Receives: Radiation: Radiation therapy; Drug: FOLFOX regimen |
| Radiation + CAPOX | Experimental | * Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted Receives: Radiation: Radiation therapy; Drug: CAPOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response Rate
- Criteria for clinical complete response:
- No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer
- No palpable tumor on DRE
- No radiographic evidence of tumor on MRI
- No suspicious mesorectal lymph nodes on MRI
- Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
Measured: Completion of treatment (estimated to be 22 weeks)
Secondary outcomes (13)
Progression-free Survival (PFS)
- Criteria for progressive disease:
- Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm)
- New metastatic disease
- PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up.
Measured: At 2 years
Incidence of Any Grade 3 or Higher Toxicity During Treatment
- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Measured: From start of treatment through the completion of treatment (estimated to be 22 weeks)
Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity
- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Measured: At 1 year after the start of radiation
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being)
- Physical Well-Being section of the FACT-C questionnaire consists of 7 questions.
- Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score for this section ranges from 0-28.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being)
- Social/Family Well-Being section of the FACT-C questionnaire consists of 7 questions.
- Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score for this section ranges from 0-28.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being)
- Emotional Well-Being section of the FACT-C questionnaire consists of 6 questions.
- Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score for this section ranges from 0-24.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being)
- Functional Well-Being section of the FACT-C questionnaire consists of 7 questions.
- Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score for this section ranges from 0-28.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale)
- Colorectal Cancer Subscale section of the FACT-C questionnaire consists of 7 scored questions.
- Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score for this section ranges from 0-28.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score)
- The FACT-G total score is calculated by adding the Physical Well Being subscale score, Social/Family Well Being subscale score, Emotional Well Being subscale score, and Functional Well Being subscale score
- Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score ranges from 0-108.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C-TOI Total Score)
- The FACT-C-Trial Outcome Index (TOI) total score is calculated by adding the Physical Well Being subscale score, Functional Well Being subscale score, and the Colorectal Cancer subscale score
- Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score ranges from 0-84.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C Total Score)
- The FACT-C total score is calculated by adding the Physical Well Being subscale score, Social/Family Well Being subscale score, Emotional Well Being subscale score, Functional Well Being subscale score, and the Colorectal Cancer subscale score
- Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life.
- The total score ranges from 0-136.
Measured: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Organ Preservation Rate
Measured: At 1 year
Organ Preservation Rate
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Jul 2020
- Primary completion21 Aug 2024
- Study completion25 Jan 2026
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 Adenocarcinoma of the Lower RectumStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Waters, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904043
- Sponsor's protocol ID
- 201904029
- Acronym
- NOM-ERA
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2019
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be shared with investigators who submit a sound proposal. Participants who opted out of data sharing in the informed consent will not be included.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Operative Management and Early Response Assessment in Rectal Cancer
- ClinicalTrials.gov ID
- NCT03904043
- Acronym / sponsor ID
- NOM-ERA / 201904029
- Conditions
- Adenocarcinoma of the Lower Rectum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation + FOLFOX | Experimental | Radiation: Radiation therapy, Drug: FOLFOX regimen* Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted |
| Radiation + CAPOX | Experimental | Radiation: Radiation therapy, Drug: CAPOX regimen* Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI
- Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
- Clinically detectable (MR, endoscopy, or DRE) tumor present
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- At least 18 years of age
Key exclusion criteria (9 listed)
- Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
- Prior oxaliplatin or capecitabine use for any malignancy
- No prior radiation therapy to the pelvis.
- A history of other malignancy (except non-melanomatous skin cancers) with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Currently receiving any investigational agents.
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 |
|---|---|---|
| Radiation therapy-Monday-Friday treatment is strongly recommended | Radiation | Radiation + CAPOX, Radiation + FOLFOX |
| FOLFOX regimen-CAPOX can be given as alternative | Drug | Radiation + FOLFOX |
| CAPOX regimenGiven as an alternative to FOLFOX | Drug | Radiation + CAPOX |
Primary outcome
Clinical Complete Response Rate
Time frame: Completion of treatment (estimated to be 22 weeks)
- Criteria for clinical complete response: * No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer * No palpable tumor on DRE * No radiographic evidence of tumor on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
13 secondary outcomes
Progression-free Survival (PFS)
Time frame: At 2 years
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Time frame: From start of treatment through the completion of treatment (estimated to be 22 weeks)
Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity
Time frame: At 1 year after the start of radiation
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C-TOI Total Score)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C Total Score)
Time frame: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapy
Organ Preservation Rate
Time frame: At 1 year
Organ Preservation Rate
Time frame: At 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with investigators who submit a sound proposal. Participants who opted out of data sharing in the informed consent will not be included.
Related trials for Adenocarcinoma of the Lower Rectum
Recruiting
Beyond TME Origins
Neoplasms, Adenocarcinoma
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.
Michael Waters, M.D., Ph.D. principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy, FOLFOX regimen and CAPOX regimen in people with Adenocarcinoma of the Lower Rectum, run by Washington University School of Medicine 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 1 May 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). 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?
Clinical Complete Response Rate (time frame: Completion of treatment (estimated to be 22 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 May 2026.