Rectal AdenocarcinomaPhase 1NCT04808323
MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
A Phase 1 study testing Capecitabine, Initial Dose of Radiation before Dose Escalation and Cohort A: Dose Escalation Radiation in people with Rectal Adenocarcinoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study is a prospective, open-label, phase I design. 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, Initial Dose of Radiation before Dose Escalation and Cohort A: Dose Escalation Radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 20 Jan 2029
- 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
- Age ≥ 18.
- Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.
- Determined on staging evaluation to be clinical stage I, II or III.
- No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise.
- Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
- History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment.
Show all 23Show fewer
- MR of the rectum is mandatory for staging and follow-up.
- Chest CT scan within 45 days prior to study entry.
- Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory.
- Laboratory values (CBC, Chem24) 45 days prior to treatment as follows:
- Carcinoembryonic antigen (CEA) (any value).
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3.
- Platelets ≥50,000 cells/mm3.
- Hemoglobin ≥ 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 4 x upper limit of normal.
- Total bilirubin < 2 x upper normal mg/dL.
- Alkaline phosphatase < 4 x upper limit of normal.
- Not on hemodialysis.
- Ability to swallow oral medications.
- Patients must be determined by medical oncology to be a candidate for systemic chemotherapy.
- Patients must provide study-specific informed consent prior to study entry.
- Negative serum pregnancy test (if applicable).
- Women of childbearing potential and male participants who are sexually active must practice adequate contraception.
Who cannot join
- Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.
- Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.
- Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
Show all 19Show fewer
- Transmural myocardial infarction within three months prior to study entry.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
- Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function.
- Any unresolved intestinal obstruction.
- Acquired immune deficiency syndrome (AIDS), based upon current Centers for Disease Control and Prevention (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with required treatment medications, such as capecitabine.
- Absence of any significant medical comorbidity which would preclude the consideration of major intestinal surgery.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Participation in another interventional clinical treatment trial while on study (observational trials are permitted).
- Patients taking nonprotocol-specified chemotherapy agents or immune-modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI.
- Poor functional status such that patients are not able to be positioned for radiation treatments.
- Gadolium allergy.
- If age over 60, history of hypertension, diabetes or liver transplant, and glomerular filtration rate (GFR) at enrollment is < 30.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
William Hall, MD, 414-805-4400, whall@mcw.edu
Carrie Peterson, MD, 414-955-5783, cypeterson@mcw.edu
About this study
This study is a prospective, open-label, phase I design.
Read the detailed description
Study Rationale: There are limited studies evaluating real-time adaptive radiation therapy for locally advanced (Stage I-III) rectal adenocarcinoma with the goal of accomplishing organ preservation. We are testing higher doses of radiation therapy, using a novel method of real-time adaptive MRI-based radiation therapy treatment.
Hypothesis: We hypothesize that adaptive magnetic resonance (MR) -guided radiation therapy will result in acceptable toxicity and that a maximum-tolerated dose can be determined in a phase I setting.
Intervention Description: The intervention in this circumstance is higher doses of radiation therapy focused within the tumor given using adaptive MR guidance. Radiation Doses being applied in this study:
Cohort A- 64 Gy over 32 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to total dose of 64 Gy over 32 total fractions.
Cohort B- 68 Gy over approximately 34 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 68 Gy over 34 total fractions.
Cohort C- 72 Gy over 36 total fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 72 Gy over 36 total fractions.
Dose-Limiting Toxicity from Radiation Therapy: A dose-limiting toxicity (DLT) as per NCI CTCAE version 5. Specifically, this encompasses the need for additional treatments including the following: transfusion, invasive intervention, or hospitalization indicated. The presence of such a DLT would result in the halting of radiation therapy and impact on the dose levels of radiation therapy applied in the trial.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Capecitabine, Initial Dose of Radiation before Dose Escalation, Cohort A: Dose Escalation Radiation, Cohort B: Dose Escalation Radiation, Cohort C: Dose Escalation Radiation
- Keywords
- MR-guided radiation therapy, Rectal adenocarcinoma
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
825 mg/m^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.
Initial Dose of Radiation before Dose EscalationDevice
50 Gy over 25 frac.
Cohort A: Dose Escalation RadiationDevice
Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.
Cohort B: Dose Escalation RadiationDevice
Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.
Cohort C: Dose Escalation RadiationDevice
Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.
FOLFOXDrug
Also called Oxaliplatin de Gramont, OxMdG
After the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Radiation dose: 64 Gy over 32 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to total dose of 64 Gy over 32 total fractions. Receives: Drug: Capecitabine; Device: Initial Dose of Radiation before Dose Escalation; Device: Cohort A: Dose Escalation Radiation; Drug: FOLFOX |
| Cohort B | Experimental | Radiation dose: 68 Gy over approximately 34 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 68 Gy over 34 total fractions. Receives: Drug: Capecitabine; Device: Initial Dose of Radiation before Dose Escalation; Device: Cohort B: Dose Escalation Radiation; Drug: FOLFOX |
| Cohort C | Experimental | Radiation dose: 72 Gy over 36 total fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 72 Gy over 36 total fractions Receives: Drug: Capecitabine; Device: Initial Dose of Radiation before Dose Escalation; Device: Cohort C: Dose Escalation Radiation; Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects in Cohort A with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Measured: Up to 11.5-week period
The number of subjects in Cohort B with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Measured: Up to 11.5-week period
The number of subjects in Cohort C with serious adverse events during radiation.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
Measured: Up to a 12.1-week period.
Secondary outcomes (13)
The number of subjects in Cohort A with a complete clinical response (CCR) to treatment.
Four weeks following completion of chemotherapy, radiation therapy (RT), and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response.
CCR is defined as meeting the following criteria:
- No palpable tumor on digital exam.
- Endoscopic evaluation consistent with the following.
- Flat scar with no ulceration and intact mucosa.
- Disappearance of neoplastic pit pattern without use of magnification.
- Disappearance of neoplastic nodule or stenosis.
Measured: 31.5 weeks
The number of subjects in Cohort B with a complete clinical response (CCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response.
CCR is defined as meeting the following criteria:
- No palpable tumor on digital exam.
- Endoscopic evaluation consistent with the following.
- Flat scar with no ulceration and intact mucosa.
- Disappearance of neoplastic pit pattern without use of magnification.
- Disappearance of neoplastic nodule or stenosis.
Measured: 31.5 weeks
The number of subjects in Cohort C with a complete clinical response (CCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response.
CCR is defined as meeting the following criteria:
- No palpable tumor on digital exam.
- Endoscopic evaluation consistent with the following.
- Flat scar with no ulceration and intact mucosa.
- Disappearance of neoplastic pit pattern without use of magnification.
- Disappearance of neoplastic nodule or stenosis.
Measured: 32.1 weeks
The number of subjects in Cohort A with a noncomplete response (NCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response.
A noncomplete clinical response is defined as any state not meeting the following criteria:
- No palpable tumor on digital exam.
- Endoscopic evaluation consistent with the following.
- Flat scar with no ulceration and intact mucosa.
- Disappearance of neoplastic pit pattern without use of magnification.
- Disappearance of neoplastic nodule or stenosis. If the tumor site does not meet the above criteria, the patient will be classified as noncomplete response (NCR).
Measured: 31.5 weeks
The number of subjects in Cohort B with a noncomplete response (NCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response.
A noncomplete clinical response is defined as any state not meeting the following criteria:
- No palpable tumor on digital exam.
- Endoscopic evaluation consistent with the following.
- Flat scar with no ulceration and intact mucosa.
- Disappearance of neoplastic pit pattern without use of magnification.
- Disappearance of neoplastic nodule or stenosis. If the tumor site does not meet the above criteria, the patient will be classified as noncomplete response (NCR).
Measured: 31.5 weeks
The number of subjects in Cohort C with a noncomplete response (NCR) to treatment.
Four weeks following completion of chemotherapy, RT, and neoadjuvant systemic chemotherapy, the patient will be evaluated by the study surgeon to assess local response.
A noncomplete clinical response is defined as any state not meeting the following criteria:
- No palpable tumor on digital exam.
- Endoscopic evaluation consistent with the following.
- Flat scar with no ulceration and intact mucosa.
- Disappearance of neoplastic pit pattern without use of magnification.
- Disappearance of neoplastic nodule or stenosis. If the tumor site does not meet the above criteria, the patient will be classified as noncomplete response (NCR).
Measured: 32.1 weeks
Circulating tumor deoxyribonucleic acid (ctDNA)
Blood samples (10 mL each time) will be collected. ctDNA is measured in percentage: variant allele fraction percentage. For simplicity this will be reported at baseline, the end of radiation, the end of neoadjuvant treatment and annually for two years.
Measured: Baseline, 12.1 weeks, 32 weeks, one year and two years.
The number of subjects with dose-limiting toxicities in Cohort A.
Number of subjects experiencing a dose-limiting toxicity (DLT) as per NCI CTCAE version 5, encompasses the need for additional treatments including the following: transfusion, invasive intervention, or hospitalization indicated. The presence of such a DLT would result in the halting of radiation therapy and impact on the dose levels of radiation therapy applied in the trial.
Measured: 11.5-week period
The number of subjects with dose-limiting toxicities in Cohort B.
Number of subjects experiencing a dose-limiting toxicity (DLT) as per NCI CTCAE version 5, encompasses the need for additional treatments including the following: transfusion, invasive intervention, or hospitalization indicated. The presence of such a DLT would result in the halting of radiation therapy and impact on the dose levels of radiation therapy applied in the trial.
Measured: 11.5-week period
The number of subjects with dose-limiting toxicities in Cohort C.
Number of subjects experiencing a dose-limiting toxicity (DLT) as per NCI CTCAE version 5, encompasses the need for additional treatments including the following: transfusion, invasive intervention, or hospitalization indicated. The presence of such a DLT would result in the halting of radiation therapy and impact on the dose levels of radiation therapy applied in the trial.
Measured: 12.1- week period
Change from baseline in the EQ-5D-SL quality of life questionnaire
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (coded as 1), slight problems (coded as 2), moderate problems (coded as 3), severe problems (coded as 4) and extreme problems (coded as 5). The score is expressed as a five-digit number. The second part of the instrument (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (score of 100) and 'The worst health you can imagine' (score of 0).
Measured: Baseline and up to 12.1 weeks.
Change from baseline in the Memorial Sloan Kettering Bowel Function Index (MSKCC BFI) Score
The MSKCC BFI comprises 18 items covering the frequency of various symptoms and is divided into three sub-scales and four single items. It is scored on a 5-point Likert scale ranging from "always" to "never". The sub-scales scores are summarised as: A 6-item frequency sub-scale (6-30), a four-item dietary sub-scale (4-20), and a four-item urgency sub-scale (4-20). A global score can be calculated as the sum of the sub-scale scores. A total score (possible score range 18-90) can be calculated by adding all the item scores (sub-scale scores plus single item scores). A higher score indicates better bowel function.
Measured: Baseline and up to 12.1 weeks.
Change from baseline in the Wexner Fecal Incontinence Score
This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence). Each of the incontinence presentations is graded equally.
Measured: Baseline and up to 12.1 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start17 Jun 2021
- Primary completion14 Apr 2027 (estimated)
- Study completion20 Jan 2029 (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 Medical College of WisconsinThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hall, Medical College of Wisconsin
- Investigators
- William Hall, MD, Principal investigator, Medical College of WisconsinCarrie Peterson, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808323
- Sponsor's protocol ID
- PRO00040139
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
- ClinicalTrials.gov ID
- NCT04808323
- Acronym / sponsor ID
- PRO00040139
- Conditions
- Rectal Adenocarcinoma
- Keywords
- MR-guided radiation therapy, Rectal adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 20 Jan 2029 (estimated)
- First posted
- 22 Mar 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.
This study is a prospective, open-label, phase I design.
Detailed description
Study Rationale: There are limited studies evaluating real-time adaptive radiation therapy for locally advanced (Stage I-III) rectal adenocarcinoma with the goal of accomplishing organ preservation. We are testing higher doses of radiation therapy, using a novel method of real-time adaptive MRI-based radiation therapy treatment.
Hypothesis: We hypothesize that adaptive magnetic resonance (MR) -guided radiation therapy will result in acceptable toxicity and that a maximum-tolerated dose can be determined in a phase I setting.
Intervention Description: The intervention in this circumstance is higher doses of radiation therapy focused within the tumor given using adaptive MR guidance. Radiation Doses being applied in this study:
Cohort A- 64 Gy over 32 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to total dose of 64 Gy over 32 total fractions.
Cohort B- 68 Gy over approximately 34 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 68 Gy over 34 total fractions.
Cohort C- 72 Gy over 36 total fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 72 Gy over 36 total fractions.
Dose-Limiting Toxicity from Radiation Therapy: A dose-limiting toxicity (DLT) as per NCI CTCAE version 5. Specifically, this encompasses the need for additional treatments including the following: transfusion, invasive intervention, or hospitalization indicated. The presence of such a DLT would result in the halting of radiation therapy and impact on the dose levels of radiation therapy applied in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Capecitabine, Device: Initial Dose of Radiation before Dose Escalation, Device: Cohort A: Dose Escalation Radiation, Drug: FOLFOXRadiation dose: 64 Gy over 32 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to total dose of 64 Gy over 32 total fractions. |
| Cohort B | Experimental | Drug: Capecitabine, Device: Initial Dose of Radiation before Dose Escalation, Device: Cohort B: Dose Escalation Radiation, Drug: FOLFOXRadiation dose: 68 Gy over approximately 34 fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 68 Gy over 34 total fractions. |
| Cohort C | Experimental | Drug: Capecitabine, Device: Initial Dose of Radiation before Dose Escalation, Device: Cohort C: Dose Escalation Radiation, Drug: FOLFOXRadiation dose: 72 Gy over 36 total fractions, prophylactic nodes treated to 50 Gy over 25 fractions, boost to tumor and radiologically positive nodes to 72 Gy over 36 total fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥ 18.
- Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.
- Determined on staging evaluation to be clinical stage I, II or III.
- No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise.
- Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
Key exclusion criteria (19 listed)
- Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.
- Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.
- Severe, active comorbidity, defined as follows:
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: Xeloda825 mg/m^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C. | Drug | Cohort A, Cohort B, Cohort C |
| Initial Dose of Radiation before Dose Escalation50 Gy over 25 frac. | Device | Cohort A, Cohort B, Cohort C |
| Cohort A: Dose Escalation RadiationCohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions. | Device | Cohort A |
| Cohort B: Dose Escalation RadiationCohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions. | Device | Cohort B |
| Cohort C: Dose Escalation RadiationCohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions. | Device | Cohort C |
| FOLFOXAlso: Oxaliplatin de Gramont, OxMdGAfter the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.) | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
The number of subjects in Cohort A with serious adverse events during radiation.
Time frame: Up to 11.5-week period
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
The number of subjects in Cohort B with serious adverse events during radiation.
Time frame: Up to 11.5-week period
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
The number of subjects in Cohort C with serious adverse events during radiation.
Time frame: Up to a 12.1-week period.
This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.
13 secondary outcomes
The number of subjects in Cohort A with a complete clinical response (CCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort B with a complete clinical response (CCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort C with a complete clinical response (CCR) to treatment.
Time frame: 32.1 weeks
The number of subjects in Cohort A with a noncomplete response (NCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort B with a noncomplete response (NCR) to treatment.
Time frame: 31.5 weeks
The number of subjects in Cohort C with a noncomplete response (NCR) to treatment.
Time frame: 32.1 weeks
Circulating tumor deoxyribonucleic acid (ctDNA)
Time frame: Baseline, 12.1 weeks, 32 weeks, one year and two years.
The number of subjects with dose-limiting toxicities in Cohort A.
Time frame: 11.5-week period
The number of subjects with dose-limiting toxicities in Cohort B.
Time frame: 11.5-week period
The number of subjects with dose-limiting toxicities in Cohort C.
Time frame: 12.1- week period
Change from baseline in the EQ-5D-SL quality of life questionnaire
Time frame: Baseline and up to 12.1 weeks.
Change from baseline in the Memorial Sloan Kettering Bowel Function Index (MSKCC BFI) Score
Time frame: Baseline and up to 12.1 weeks.
Change from baseline in the Wexner Fecal Incontinence Score
Time frame: Baseline and up to 12.1 weeks.
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 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Rectal Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
William Hall, MD principal investigator
Medical College of Wisconsin
Carrie Peterson, MD principal investigator
Medical College of Wisconsin
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 Capecitabine, Initial Dose of Radiation before Dose Escalation and Cohort A: Dose Escalation Radiation in people with Rectal Adenocarcinoma, run by Medical College of Wisconsin 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 23 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: looking for participants now, as of the sponsor's last update on 16 Mar 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?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (414-805-8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects in Cohort A with serious adverse events during radiation. (time frame: Up to 11.5-week period). The study lists 3 primary outcomes in all. 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 16 Mar 2026.