Stage IV Colon Cancer Clinical Trial
Official title:
Pilot Study Assessing the Correlation Between Telomere Length and Chemotherapy- Related Toxicity Among Early Stage and Metastatic Colorectal Patients Over the Age of 70
This pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.
PRIMARY OBJECTIVES:
I. To determine the relationship between pre-treatment telomere length (TL) and rate of grade
3 or higher adverse events occurring on front line leucovorin calcium, fluorouracil, and
oxaliplatin (FOLFOX)-based chemotherapy among patients over the age of 70 with early stage or
metastatic colorectal cancer (CRC).
SECONDARY OBJECTIVES:
I. To evaluate the impact of the FOLFOX-based chemotherapy treatment on peripheral blood
lymphocyte telomere length.
II. To evaluate the association between pre-treatment geriatric assessment tools scores,
telomere length, and the incidence of chemotherapy related adverse events among older early
stage or metastatic CRC patients.
TERTIARY OBJECTIVES:
I. To evaluate the association between pre-treatment levels of serum interleukin-6 (IL-6),
C-reactive protein (CRP) and D-dimer and incidence of chemotherapy related adverse events.
II. To evaluate the correlation between pre-treatment telomere length, levels of other
biomarkers of aging (IL6, CRP, D-dimer), and rates of adverse events with FOLFOX-based
chemotherapy.
OUTLINE:
Patients undergo blood sample collection for analysis via real-time polymerase chain reaction
(PCR) at baseline, 3 months, and 6 months.
After completion of study, patients are followed up every 3 months for up to 2 years.
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