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Chemotherapy

MRI-Guided Radiation + Chemotherapy for Rectal Cancer

Phase 1
Recruiting
Led By William Hall, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12.1 weeks, 32 weeks, one year and two years.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and works well.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include fatigue, skin irritation at the radiation site, nausea from chemo drugs, low blood cell counts leading to increased infection risk or bleeding problems, liver enzyme changes, and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is confirmed rectal adenocarcinoma.
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I am 18 years old or older.
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My cancer has not clearly spread to distant parts of my body.
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My cancer is at an early to mid-stage (I, II, or III).
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I've had a recent check-up with weight and vital signs recorded.
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I have been active and mostly self-sufficient in the last 45 days.
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I have had an MRI of the rectum for cancer staging.
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I can undergo MR scans for my abdomen and pelvis for cancer treatment planning.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12.1 weeks, 32 weeks, one year and two years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12.1 weeks, 32 weeks, one year and two years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of subjects in Cohort A with serious adverse events during radiation.
The number of subjects in Cohort B with serious adverse events during radiation.
The number of subjects in Cohort C with serious adverse events during radiation.
Secondary outcome measures
Change from baseline in the EQ-5D-SL quality of life questionnaire
Cathartics
Change from baseline in the Wexner Fecal Incontinence Score
+10 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
FOLFOX
2009
Completed Phase 3
~4560

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,475 Total Patients Enrolled
William Hall, MDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
3 Previous Clinical Trials
477 Total Patients Enrolled
Carrie Peterson, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04808323 — Phase 1
Rectal Cancer Research Study Groups: Cohort A, Cohort B, Cohort C
Rectal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04808323 — Phase 1
Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04808323 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for volunteers in this clinical investigation?

"As indicated in the clinicaltrials.gov registry, this medical trial is currently accepting patients; it was initially listed on June 17th 2021 and underwent its final edit on July 19th 2022."

Answered by AI

What is the intended outcome of this medical experiment?

"This clinical trial is primarily assessing the number of subjects in Cohort A with serious adverse events during radiation over an 11.5-week period. Secondary objectives include ascertaining the amount of participants in Cohort B who experience a complete clinical response to treatment, as well as changes from baseline for both Memorial Sloan Kettering Bowel Function Index (MSKCC BFI) Score and Wexner Fecal Incontinence Scores."

Answered by AI

Has there been any past experimentation with Introductory Radiation Dosage prior to Increasing the Amount?

"Presently, there are 549 active trials for Initial Dose of Radiation before Dose Escalation worldwide. Of these studies, 190 have progressed to Phase 3 with most being held in Woolloongabba, Queensland. However, overall 20613 locations are running investigations into this therapy."

Answered by AI

Has the FDA sanctioned an initial dose of radiation prior to increasing dosage?

"With limited data available to support safety and efficacy, the team at Power assign Initial Dose of Radiation before Dose Escalation a score of 1 on their scale from 1 to 3."

Answered by AI

What is the highest number of participants involved in this clinical research?

"Indeed, according to the clinicaltrials.gov page associated with this medical trial, patient recruitment is presently underway. This particular investigation was initially uploaded on June 17th 2021 and later amended on July 19th 2022. The study aims at enrolling 22 individuals from a single location."

Answered by AI

What maladies are typically treated with Initial Dose of Radiation before Dose Escalation?

"A Preliminary Radiation Dose before Dosage Increase is often prescribed to treat metastatic colorectal carcinoma, but has also proven effective in treating pancreatic endocrine carcinoma, stage III colon cancer and refractory ovarian cancer."

Answered by AI
~7 spots leftby Jun 2025