MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests radiation treatment guided and adjusted using MRI scans, with the goal of keeping the rectum. It is for adults with stage I, II, or III rectal cancer.
This study is a prospective, open-label, phase I design.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with rectal adenocarcinoma confirmed by a tissue or cell test. This is cancer that starts in gland cells.
- Stage I, II, or III cancer, with no clear spread to distant parts of the body. Unclear spots may be allowed after review by the cancer team.
- Able to care for yourself and be up and about for at least half the day, based on an activity check within 45 days of joining.
- Have the required exam, CT scans, and MRI scans for planning treatment and checking results. Some tests must be done within 45 days of joining or starting treatment.
- Meet blood cell and liver test limits on blood tests before treatment. Blood transfusions to raise hemoglobin, which carries oxygen, are allowed.
- Not receiving hemodialysis, a treatment that filters blood when kidneys fail.
- Able to swallow medicines, and approved by a cancer doctor to receive chemotherapy that treats the whole body.
- Sign a study consent form. Have a negative blood pregnancy test if needed, and use birth control as required.
Who can't join
- Cancer proven to have spread to distant parts of the body, or strong concern for spread with cancer team agreement that it is stage IV.
- A past invasive cancer, unless cancer-free for at least 3 years. Exceptions include nonmelanoma skin cancer, noninvasive breast cancer, and prostate cancer being watched without treatment.
- Past radiation that overlaps the treatment area, or major surgery within 28 days of joining. Certain bowel procedures and placement of a tube for blood vessel access are allowed.
- Certain serious health problems, including recent heart or lung problems, an infection needing IV treatment, uncontrolled trouble absorbing food, a blocked bowel, or AIDS.
- Pregnancy, or inability or unwillingness to use required birth control during treatment and afterward: 3 months for women and 6 months for men.
- Taking part in another treatment trial, or taking chemotherapy or medicines that change immune system activity outside the study plan. Studies that only observe patients are allowed.
- Unable to get into position for radiation treatment, or an allergy to gadolinium, a dye used for MRI scans.
- A kidney filtering test result below 30, together with age over 60 or a history of high blood pressure, diabetes, or liver transplant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age ≥ 18. 2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum. 3. Determined on staging evaluation to be clinical stage I, II or III. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry. 6. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment. 7. MR of the rectum is mandatory for staging and follow-up. 8. Chest CT scan within 45 days prior to study entry. 9. 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. 10. Laboratory values (CBC, Chem24) 45 days prior to treatment as follows: 1. Carcinoembryonic antigen (CEA) (any value). 2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3. 3. Platelets ≥50,000 cells/mm3. 4. Hemoglobin ≥ 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal. 6. Total bilirubin \< 2 x upper normal mg/dL. 7. Alkaline phosphatase \< 4 x upper limit of normal. 11. Not on hemodialysis. 12. Ability to swallow oral medications. 13. Patients must be determined by medical oncology to be a candidate for systemic chemotherapy. 14. Patients must provide study-specific informed consent prior to study entry. 15. Negative serum pregnancy test (if applicable). 16. Women of childbearing potential and male participants who are sexually active must practice adequate contraception. Exclusion Criteria: 1. Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease. 2. 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 3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. 4. Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion. 5. Severe, active comorbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last six months. 2. Transmural myocardial infarction within three months prior to study entry. 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration. 5. Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function. 6. Any unresolved intestinal obstruction. 7. 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. 8. Absence of any significant medical comorbidity which would preclude the consideration of major intestinal surgery. 6. 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. 7. Participation in another interventional clinical treatment trial while on study (observational trials are permitted). 8. 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. 9. Poor functional status such that patients are not able to be positioned for radiation treatments. 10. Gadolium allergy. 11. If age over 60, history of hypertension, diabetes or liver transplant, and glomerular filtration rate (GFR) at enrollment is \< 30.
Study sites (1)
WI
- Froedtert & the Medical College of Wisconsin · Milwaukee, WI 53226William Hall, MD · Study contact · 414-805-4400 · whall@mcw.eduCarrie Peterson, MD · Study contact · 414-955-5783 · cypeterson@mcw.eduCarrie Peterson, MD · Principal investigatorWilliam Hall, MD · Principal investigatorMore trials in Milwaukee