Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
(M&M Trial)
Recruiting at 208 trial locations
KC
Overseen ByKaren Craver
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
Must be taking: Immunotherapy, 5-FU chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.
Who Is on the Research Team?
GR
Grant R Williams, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
Inclusion Criteria
Newly diagnosed metastatic CRC or metastatic recurrence of CRC >= to 3 months (12 weeks) 1 year from diagnosis at age >= 60y.
Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable.
Estimated life expectancy >= 6 months.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemotherapy
Participants receive 5-Fluorouracil (5FU) systemic chemotherapy to assess the impact of myopenia on chemotherapy toxicity
Up to 6 months
Follow-up
Participants are monitored for overall survival and chemotherapy toxicity
1 year
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Trials
1,432
Recruited
2,506,000+
University of Alabama at Birmingham
Collaborator
Trials
1,677
Recruited
2,458,000+
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