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Chemotherapy
Chemoradiation for Rectal Cancer
Phase < 1
Waitlist Available
Led By Jessica M Frakes, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have the ability to swallow and retain oral medications
Histologically confirmed diagnosis of adenocarcinoma of the rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether using MRI to guide chemoradiation therapy can improve response to treatment.
Who is the study for?
This trial is for adults with Stage II or III rectal adenocarcinoma, confirmed by MRI. Participants must be able to take oral meds, have good organ function and blood counts, not be pregnant or breastfeeding, and willing to use birth control. Excluded are those with unresectable cancer, prior invasive rectal malignancy, metastatic disease outside the radiation field, HIV/AIDS, inability to undergo MRI due to medical reasons (except controlled anxiety), major surgery within 12 weeks before enrollment, known DPD deficiency.Check my eligibility
What is being tested?
The study tests if MRI-guided adaptive chemoradiation therapy can better treat locally advanced rectal cancer. It involves using Capecitabine pills alongside radiation therapy and possibly adding FOLFOX regimen (a combination of chemotherapy drugs) depending on individual responses.See study design
What are the potential side effects?
Possible side effects include skin irritation from radiation; fatigue; nausea; diarrhea from Capecitabine; low blood cell counts leading to increased infection risk or bleeding problems; liver issues; neuropathy (tingling in hands/feet) from FOLFOX.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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My diagnosis is rectal adenocarcinoma.
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I am fully active or have some restrictions but can still care for myself.
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My rectal cancer is at an early to mid-stage and close to the front of my pelvic area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of MRI guided dose adaptive chemoradiation therapy
Secondary outcome measures
Number of Participants with Complete Clinical Response (cCR)
Number of Participants with Pathological Complete Response (pCR)
Other outcome measures
Number of Participants with Disease-Free Survival (DFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI-guided adaptive radiationExperimental Treatment3 Interventions
Patients will receive capecitabine-based chemoradiotherapy (chemotherapy with capecitabine + radiation). Dosing will be modified based on tumor changes measured daily and weekly by MR-guided radiotherapy (MRgRT) utilizing MR-linac (MRL) systems. Chemoradiotherapy will be followed by standard of care consolidated chemotherapy. (FOLFOX)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Radiation Therapy
2017
Completed Phase 3
~7250
FOLFOX regimen
2009
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,472 Total Patients Enrolled
Viewray Inc.Industry Sponsor
12 Previous Clinical Trials
1,069 Total Patients Enrolled
Natera, Inc.Industry Sponsor
47 Previous Clinical Trials
42,347 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV/AIDS.My blood clotting tests are normal, or I'm stable on blood thinners like warfarin.I have not had cancer treatment in the last 3 years, except for basal cell skin cancer or cervical cancer.My rectal cancer cannot be surgically removed due to its spread.I have not had a heart attack, stroke, or severe chest pain in the last 6 months.I cannot have MR imaging due to medical reasons, but anxiety is not a barrier for me.My tumor is not causing blockage in my intestines.My scans show cancer has spread outside the radiation area.My BMI is 40 or less.I have not had major surgery in the last 12 weeks.I have inflammatory bowel disease or had abdominal surgery affecting my digestion.My rectal cancer is not adenocarcinoma but another type.I have had radiation therapy to my pelvic area before.I can swallow and keep down pills.My diagnosis is rectal adenocarcinoma.I am fully active or have some restrictions but can still care for myself.I am not currently on any experimental treatments.My kidney function is good as per recent tests.My rectal cancer is at an early to mid-stage and close to the front of my pelvic area.I have had rectal cancer before or have a family history of polyposis syndrome.I have more than one colorectal cancer at the same time.I have seizures that medication does not control.My liver is functioning well, as tested within the last 45 days.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: MRI-guided adaptive radiation
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate on any other research conducted in regards to Radiation Therapy?
"Presently, 334 clinical trials are researching Radiation Therapy; of those investigations, 126 have reached Phase 3. Woolloongabba in Queensland is a hub for these studies however there are 12868 other locations offering this treatment."
Answered by AI
How many individuals are being provided with care as part of this research?
"Affirmative. According to the records hosted on clinicaltrials.gov, this medical trial began recruitment efforts on October 23rd 2021 and is still actively searching for volunteers today. The study requires 20 participants from 1 site to meet its enrolment goals."
Answered by AI
For which medical conditions is Radiation Therapy regularly employed?
"Radiation Therapy is a viable course of treatment for malignant neoplasms, pancreatic endocrine carcinoma, and colorectal carcinoma."
Answered by AI
Who else is applying?
What site did they apply to?
Moffitt Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
My doctors were not interested in exploring other options,except surgery and a bag.
PatientReceived 1 prior treatment
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