The purpose of this study is to determine the pathological complete tumor response rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56.
Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.
Unnamed facility
Basel, Switzerland
Unnamed facility
Chur, Switzerland
Unnamed facility
Lucerne, Switzerland
Unnamed facility
Sankt Gallen, Switzerland
Unnamed facility
Zurich, Switzerland
Percentage of Participants With Pathological Complete Tumor Response
Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).
Time frame: Up to Week 16
Percentage of Participants With Sphincter-preservation
Percentage of participants with sphincter-preservation is reported.
Time frame: Up to Week 16
Number of Participants With Marked Laboratory Abnormalities
Number of participants with marked laboratory abnormalities is reported.
Time frame: Up to Week 16
Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer
R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.
Time frame: Up to Week 16
Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes
Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).
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Unnamed facility
Zurich, Switzerland
Time frame: From screening to Week 16
Percentage of Participants With Pathological Incomplete Tumor Response
Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.
Time frame: Up to Week 16
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Week 16