Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
Phase 3
250
about 6 years
18+
99 sites in AZ, CA, DE +25
What this study is about
Researchers are testing whether chemotherapy alone before surgery is as effective as chemotherapy and radiation therapy together before surgery for rectal cancer. The trial also compares the quality of life between these two treatment approaches.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Radiation
- 2.Take Capecitabine
- 3.Take Fluoruracil
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
capecitabine, fluorouracil (Antimetabolite; mimics uracil to disrupt DNA/RNA in cancer cells), Antidotes, Deterrents, and Toxicologic Agents (Enzyme Interactions), oxaliplatin
oral (Oral Tablet), injection (Injection)
Primary: Clinical response rate upon re-staging, Quality of Life defined using the LARS score
Secondary: Disease Free Survival, Number and severity of adverse events utilizing CTCAE v5.0, Other QoL functions assessed by subscales of EORTC QLQ-C30, Other QoL functions assessed by subscales of FIQL, Other QoL functions assessed by subscales of subscales of EORTC QLQ-CR29, Overall Survival, Validate the magnetic resonance tumour regression grade (MR-TRG) in patients with T1-T3a rectal cancer
radiation
Oncology