Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Trial Details

NCT ID
NCT06205485
Phase
PHASE3
Sponsor
Canadian Cancer Trials Group
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Leucovorin
  • Oxaliplatin
  • Fluoruracil
  • Capecitabine
  • Radiation
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Irvine, California, United States|33.66946,-117.82311
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
  • MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\*. \* T3a: \<1mm depth invasion, T3b: 1-5mm depth of invasion.
  • cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous inv…
  • M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.

For full eligibility, visit ClinicalTrials.gov.

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