A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer
Canadian Cancer Trials Group
Summary
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?
Description
This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years. If a patient d…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 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…
Interventions
- DrugLeucovorin
400 mg/m2
- DrugOxaliplatin
85 mg/m2 or 130 mg/m2 on day 1
- DrugFluoruracil
bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2
- DrugCapecitabine
1,000 mg/m2 twice daily for 14 days
- RadiationRadiation
54 Gy (27-30 fractions)
Locations (105)
- Cancer Center at Saint Joseph'sPhoenix, Arizona
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- Los Angeles General Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- Beebe South Coastal Health CampusMillville, Delaware