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Back|NCT06205485Recruiting
Official Title

A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

Phase
Phase 3
Sponsor
Canadian Cancer Trials Group
Enrollment
250
Timeline
Jun 2024 → Jun 2030
About This Study

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

Inclusion Criteria

  • 1Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
  • 2MRI stage cT1 not eligible for transanal surgery or cT2-T3a.
  • 3cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
  • 4M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
  • 5Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
  • 6Medically fit to undergo radical TME surgery as per treating surgeon's decision.
  • 7Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.
  • 8Age of at least 18 years.
  • 9No contraindications to protocol chemotherapy.
  • 10Adequate normal organ and marrow function: ANC ≥ x 10\^9/L; platelet count ≥ 100 x 10\^9/L; bilirubin \< 1.5 UNL, excluding Gilbert's syndrome; Estimated creatinine clearance of ≥ 50ml/min
  • 11Patient must have an ECOG performance of \<2 (or Karnofsty ≥ 60%).
  • 12Must be accessible for treatment and follow-up
  • 13Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.
  • 14HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Exclusion Criteria

  • 1Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
  • 2Patients with visible pelvic sidewall nodes on MRI.
  • 3Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
  • 4Previous pelvic radiation for any reason, including brachytherapy alone.
  • 5Patients who have had primary lesion excised prior to enrollment. If a patient has had partial excision prior to enrollment, there must be gross residual disease endoscopically for patient to be eligible.
  • 6Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • 7Prior treatment for rectal cancer.
  • 8Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).
  • 9Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
  • 10Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • 11Any contra-indications to undergo MRI imaging.
  • 12Presence of anterior lesions above or near peritoneal reflection rendering the patient ineligible for a transanal tumour excision.
  • 13T3 tumours invading or abutting the internal sphincter.

Locations

92 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Patrick S. Sullivan

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Patrick S. Sullivan

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Patrick S. Sullivan

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →