Rectal cancer. Malignant neoplasm of rectum
Conditions
Interventions
Intervention group: The patients with rectal cancer will receive a cycle of chemotherapy (with CAPOX regimen) followed by short course RT followed by 2 weeks’ rest followed by 2 cycles of chemotherapy
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with newly diagnosed rectal cancer with up to 16 cm distance from anal verge Histologically confirmed adenocarcinoma Initial pathological stage of T3 or T4 and/or N+ No history of initial distant metastases ECOG-performance status < 2 6. Age = 18 years Adequate bone marrow, hepatic and renal functions Signing the informed consent
Exclusion criteria
Exclusion criteria: Pregnancy Previous pelvic radiotherapy Hypersensitivity to fluorouracil, oxaliplatin or capecitabine Serious medical illness Distance metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response. Timepoint: Post operation. Method of measurement: Pathologic examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: Weekly during intervention course. Method of measurement: Radiation therapy oncology group toxicity criteria. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Akbar Hafezi
Shiraz University of Medical Sciences
Outcome results
None listed