Rectal cancer. Malignant neoplasm of rectum
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: pathologically proved adenocarcinoma of the rectum; age 18 years old or older; clinically staged II-III tumor by MRI and/or EUS; ECOG performance status of 0 or 1; no previous history of malignancy, pelvic radiotherapy or chemotherapy; normal or adequate bone marrow reserve; normal or adequate liver and kidney function. Exclusion criteria: patients with distant metastatic disease; prior history of radiation therapy to the pelvis; prior history of chemotherapy for rectal cancer; active connective tissue disease such as scleroderma or Crohn's disease; uncontrolled diabetes mellitus, hypertension or recent cardiovascular disease; significant neuropathy; any previous or recent hypersensitivity or contraindication for chemotherapy agents.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response. Timepoint: Before intervention and After surgical resection. Method of measurement: Pathologic examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-related side effects. Timepoint: Weekly measurement from the first week to the end of intervention. Method of measurement: According to the Common Terminology Criteria for Adverse Events (version 4.0). | — |
Countries
Iran (Islamic Republic of)
Contacts
Shiraz University of Medical Sciences