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Study details
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Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Canadian Cancer Trials Group
NCT IDNCT06205485ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

250

Study length

about 6 years

Ages

18+

Locations

99 sites in AZ, CA, DE +25

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive Radiation
  • 2.Take Capecitabine
  • 3.Take Fluoruracil
  • +2 more
PhasePhase 3
DrugCapecitabine
Routeoral
Primary goalClinical response rate upon re-staging

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

capecitabine, fluorouracil (Antimetabolite; mimics uracil to disrupt DNA/RNA in cancer cells), Antidotes, Deterrents, and Toxicologic Agents (Enzyme Interactions), oxaliplatin

Drug routes

oral (Oral Tablet), injection (Injection)

Endpoints

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

Procedures

radiation

Body systems

Oncology