Rectal Adenocarcinoma. Malignant neoplasm of rectum
Conditions
Interventions
Intervention 1: ?1st Arm: Short course radiotherapy with 25 Gy in 5 fractions with concurrent chemotherapy regimen including Capecitabine 625mg/m2/bid for 5 days and Oxaliplatin 50mg/m2/day for 1 day
Treatment - Drugs
?1st Arm: Short course radiotherapy with 25 Gy in 5 fractions with concurrent chemotherapy regimen including Capecitabine 625mg/m2/bid for 5 days and Oxaliplatin 50mg/m2/day for 1 day then one cycle c
2nd Arm (Control): Long course radiotherapy with 50 Gy in 25 fractions with concurrent Capecitabine 825mg/m2/bid for 5 days each week then one cycle chemotherapy with XELOX regimen (Capecitabine 1000m
Sponsors
Deputy of Research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Rectal Adenocarcinoma Confirmed by Pathology; Both Genders; Ages 18 to 80; Clinical Stages T3-4 or Lymph node Positive by MRI or Endosonography; Tumor Location 5 to 15 cm above anal verge; Good Performance Status (Eastern Cooperative Oncology Group 0-1). Exclusion Criteria: Concurrent Malignancy other than Rectal Cancer; No tolerance for Chemotherapy; Previous Pelvic Radiotherapy; Distant Metastasis; Impaired Renal Function.
Exclusion criteria
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Postop Tumor Stage. Timepoint: After Surgery. Method of measurement: Pathology Report. | — |
Primary
| Measure | Time frame |
|---|---|
| Complications. Timepoint: At the Initiation of Radiotherapy up to one month after surgery. Method of measurement: Common terminology criteria for cancer related therapy adverse events. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdi Aghili
Department of Radiation Oncology, Tehran University of Medical Sciences
Outcome results
None listed