Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Leucovorin
- Oxaliplatin
- Fluoruracil
- Capecitabine
- Radiation
Treatment groups
250 Participants
are divided into 2 treatment groupsLocations
109Canada
British Columbia
BCCA-Vancouver Cancer CentreV5Z 4E6, Vancouver Canada
Manitoba
CancerCare ManitobaR3E 0V9, Winnipeg Canada
Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer CentreA1B 3V6, St. John's Canada
Ontario
London Regional Cancer ProgramN6A 4L6, London Canada
Sponsors and collaborators
Canadian Cancer Trials Group
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborator
ECOG-ACRIN Cancer Research Group
Collaborator
NRG Oncology
Collaborator
SWOG Cancer Research Network
Collaborator
Source ClinicalTrials.gov