MRI-Guided Radiation + Chemotherapy for Rectal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Medical College of Wisconsin
Must not be taking: Antiretrovirals, Chemotherapy, Immunomodulators
Disqualifiers: Metastatic disease, Prior malignancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is a prospective, open-label, phase I design.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it does mention that patients taking nonprotocol-specified chemotherapy or immune-modulating agents cannot participate. It's best to discuss your current medications with the trial's principal investigator.
What data supports the effectiveness of the treatment MRI-Guided Radiation + Chemotherapy for Rectal Cancer?
Research on MRI-guided radiation therapy (MRgRT) shows promise in improving treatment outcomes by better targeting tumors and sparing healthy organs, as seen in studies on pancreatic and prostate cancers. This suggests that similar benefits might be expected for rectal cancer, potentially enhancing the effectiveness of the treatment.
12345Is MRI-guided radiation therapy safe for treating cancer?
MRI-guided radiation therapy has been used safely in treating various cancers, including prostate and abdominal tumors. Studies have shown that it can reduce side effects compared to traditional methods, with some patients experiencing mild to moderate side effects like urinary or gastrointestinal issues, which generally improve over time.
56789What makes MRI-Guided Radiation + Chemotherapy for Rectal Cancer unique compared to other treatments?
This treatment is unique because it uses MRI-guided radiation therapy, which provides better imaging of soft tissues and allows for real-time adjustments during treatment to target tumors more precisely while sparing healthy organs. This approach can potentially reduce side effects and improve outcomes compared to traditional radiation therapy.
456910Eligibility Criteria
This trial is for adults over 18 with rectal cancer that's not spread far (stage I-III). They must be able to swallow pills, have certain blood counts and organ function, and undergo MRI scans. Pregnant women can't join, nor those with recent major surgery or other serious health issues.Inclusion Criteria
My condition is confirmed rectal adenocarcinoma.
I am 18 years old or older.
My cancer has not clearly spread to distant parts of my body.
+7 more
Exclusion Criteria
I haven't had major surgery in the last 28 days, except for specific minor procedures.
Severe, active comorbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last six months, 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.
My cancer has spread to distant parts of my body, confirmed by a biopsy or doctor's consensus.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Therapy
Participants receive adaptive MRI-guided radiation therapy with varying doses depending on cohort
11.5-12.1 weeks
Follow-up
Participants are monitored for safety and effectiveness after radiation therapy
4 weeks
Long-term Follow-up
Participants are evaluated for long-term outcomes including ctDNA and quality of life assessments
Up to 2 years
Participant Groups
The study tests how well patients respond to different doses of radiation therapy guided by MRI scans alongside chemotherapy drugs like Capecitabine and FOLFOX. It's a phase I trial where the safety and best dose of radiation are being figured out.
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment4 Interventions
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
Group II: Cohort BExperimental Treatment4 Interventions
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.
Group III: Cohort AExperimental Treatment4 Interventions
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.
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Xeloda for:
- Colorectal cancer
- Breast cancer
🇺🇸 Approved in United States as Xeloda for:
- Colorectal cancer
- Breast cancer
🇨🇦 Approved in Canada as Xeloda for:
- Colorectal cancer
- Breast cancer
🇯🇵 Approved in Japan as Xeloda for:
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Froedtert & the Medical College of WisconsinMilwaukee, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Magnetic Resonance-Guided Prostate Stereotactic Body Radiation Therapy With Daily Online Plan Adaptation: Results of a Prospective Phase 1 Trial and Supplemental Cohort. [2022]Stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) for prostate cancer allows for MR-based contouring, real-time MR motion management, and daily plan adaptation. The clinical and dosimetric benefits associated with prostate SMART remain largely unknown.
Exploring MR regression patterns in rectal cancer during neoadjuvant radiochemotherapy with daily T2- and diffusion-weighted MRI. [2021]To date, only limited magnetic resonance imaging (MRI) data are available concerning tumor regression during neoadjuvant radiochemotherapy (RCT) of rectal cancer patients, which is a prerequisite for adaptive radiotherapy (RT) concepts. This exploratory study prospectively evaluated daily fractional MRI during neoadjuvant treatment to analyze the predictive value of MR biomarkers for treatment response.
Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. [2022]To implement a robust and fast stereotactic MR-guided adaptive radiation therapy (SMART) online strategy in locally advanced pancreatic cancer (LAPC).
Identification of patients with locally advanced pancreatic cancer benefitting from plan adaptation in MR-guided radiation therapy. [2020]MR-guided radiation therapy (MRgRT) with daily plan adaptation is a novel but time- and resource-intensive treatment for locally advanced pancreatic cancer (LAPC). We analyzed the benefit in target coverage and organ-at-risk (OAR) sparing of daily plan adaptation in 36 consecutive LAPC patients treated with MRgRT to 40 Gy in 5 fractions.
Clinical outcomes of stereotactic magnetic resonance image-guided adaptive radiotherapy for primary and metastatic tumors in the abdomen and pelvis. [2022]Stereotactic body radiotherapy (SBRT) delivers ablative doses with excellent local control. However, implementing SBRT for abdominal and pelvic tumors has been limited by the risk for treatment-related gastrointestinal toxicity. MRI-guided radiotherapy may ameliorate these risks and increase the therapeutic ratio. We report the clinical outcomes of stereotactic MRI-guided adaptive radiotherapy (SMART) for primary and metastatic tumors in the abdomen and pelvis.
MRI-guided Pelvic Radiation Therapy: A Primer for Radiologists. [2023]Radiation therapy (RT) is a core pillar of oncologic treatment, and half of all patients with cancer receive this therapy as a curative or palliative treatment. The recent integration of MRI into the RT workflow has led to the advent of MRI-guided RT (MRIgRT). Using MRI rather than CT has clear advantages for guiding RT to pelvic tumors, including superior soft-tissue contrast, improved organ motion visualization, and the potential to image tumor phenotypic characteristics to identify the most aggressive or treatment-resistant areas, which can be targeted with a more focal higher radiation dose. Radiologists should be familiar with the potential uses of MRI in planning pelvic RT; the various RT techniques used, such as brachytherapy and external beam RT; and the impact of MRIgRT on treatment paradigms. Current clinical experience with and the evidence base for MRIgRT in the settings of prostate, cervical, and bladder cancer are discussed, and examples of treated cases are illustrated. In addition, the benefits of MRIgRT, such as real-time online adaptation of RT (during treatment) and interfraction and/or intrafraction adaptation to organ motion, as well as how MRIgRT can decrease toxic effects and improve oncologic outcomes, are highlighted. MRIgRT is particularly beneficial for treating mobile pelvic structures, and real-time adaptive RT for tumors can be achieved by using advanced MRI-guided linear accelerator systems to spare organs at risk. Future opportunities for development of biologically driven adapted RT with use of functional MRI sequences and radiogenomic approaches also are outlined. ©RSNA, 2023 Quiz questions for this article are available in the supplemental material.
1.5T MR-Guided Daily-Adaptive SBRT for Prostate Cancer: Preliminary Report of Toxicity and Quality of Life of the First 100 Patients. [2022]Purpose: The present study reports the preliminary outcomes in terms of adverse events and quality of life in the first 100 patients treated with 1.5T MR-guided daily-adaptive stereotactic body radiotherapy for prostate cancer. Methods: From October 2019 to December 2020, 100 patients, enrolled in a prospective study, received MR-guided SBRT for prostate cancer. Rectal spacer insertion was optional and administered in 37 patients. In total, 32 patients received androgen deprivation therapy in accordance with international guidelines. A prospective collection of data regarding toxicity and quality of life was performed. Results: The median age was 71 years (range, 52-84). The median total dose delivered was 35 Gy (35-36.25 Gy) in five sessions, either on alternate days (n = 25) or consecutive days (n = 75). For acute toxicity, we recorded: seven cases of acute G2 urinary pain and four cases of G2 gastrointestinal events. The median follow-up was 12 months (3-20), recording three late G2 urinary events and one G3 case, consisting of a patient who required a TURP 8 months after the treatment. For gastrointestinal toxicity, we observed 3 G ≥ 2 GI events, including one patient who received argon laser therapy for radiation-induced proctitis. Up to the last follow-up, all patients are alive and with no evidence of biochemical relapse, except for an M1 low-volume patient in distant progression two months after radiotherapy. QoL evaluation reported a substantial resolution of any discomfort within the second follow-up after radiotherapy, with the only exception being sexual items. Notably, after one year, global health items were improved compared to the baseline assessment. Conclusions: This study reports very promising outcomes in terms of adverse events and QoL, supporting the role of 1.5T MR-guided SBRT for prostate cancer. To date, this series is one of the first and largest available in the literature. Long-term results are warranted.
A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac. [2020]Magnetic Resonance (MR)-guided online adaptive radiation therapy (MRgOART), enabled with MR-Linac, has potential to revolutionize radiation therapy. MRgOART is a complex process. This work is to introduce a comprehensive end-to-end quality assurance (QA) workflow in routine clinic for MRgOART with a high-magnetic-field MR-Linac.
Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. [2021]Adaptive magnetic resonance imaging-guided radiation therapy (MRgRT) can escalate dose to tumors while minimizing dose to normal tissue. We evaluated outcomes of inoperable pancreatic cancer patients treated using MRgRT with and without dose escalation.
Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. [2023]Magnetic resonance image-guided radiotherapy (MRIgRT) has been clinically implemented since 2014. This technology offers improved soft-tissue visualisation, daily imaging, and intra-fraction real-time imaging without added radiation exposure, and the opportunity for adaptive radiotherapy (ART) to adjust for anatomical changes. Here we share the longest single-institution experience with MRIgRT, focusing on trends and changes in use over the past 4.5 years.