RecruitingRectal Cancer

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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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?

Sponsor: Canadian Cancer Trials Group

You may qualify if…

✓ 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 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.
✓ Medically fit to undergo radical TME surgery as per treating surgeon's decision.
✓ Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.
✓ Age of at least 18 years.

You may not qualify if…

✕ Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
✕ Patients with visible pelvic sidewall nodes on MRI.
✕ Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
✕ Previous pelvic radiation for any reason, including brachytherapy alone.
✕ Patients 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.
✕ Patients 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.
✕ Prior treatment for rectal cancer.
✕ Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).