CCTG-CO32

Clinical Trial Title The NEO-RT Trial: A phase 3 randomized trial of neoadjuvant chemotherapy, excision and observation versus chemoradiotherapy for early rectal cancer
Trial Status Open to Enrollment
Start Date 06/11/2024
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Rectal cancer
Description 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?
Eligibility Criteria

Eligibility Criteria

  • Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
  • MRI stage:
    a) cT1 not eligible for transanal surgery alone as per NCCN guidelines, (including but not limited to T1 tumours >2 cm in size, positive margin, tumour depth SM3 invasion to the lower third of the submucosal level).
    or
    b) cT2
  • cN0 stage based on pelvic MRI – including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
  • M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
  • Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.

Ineligibility Criteria

  • Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology, lymphatic/vascular or perineural invasion.
Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer | ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org