Rectal adenocarcinoma. Malignant neoplasm of rectum
Conditions
Interventions
Intervention 1: Intervention group: Pelvic radiotherapy + capecitabine, then neoadjuvant chemo (FOLFOX/CapOx), then surgery. Intervention 2: Control group: Pelvic radiotherapy + surgery, then adjuvant
Sponsors
Sabzevar University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: proved pathologic diagnosis of rectum adenocarcinoma ECOG performance status of 0–2 adequete bown marrow function includes Hb>10g/ml - WBC> 3 × 109/l - Neut>1.5×109/l - plt> 100 × 109/l adequete liver function( Maximum SGOT and SGPT 3 times than normal)
Exclusion criteria
Exclusion criteria: Absence of informed consent for inclusion in the study The presence of synchronous adenocarcinoma in other regions of the colon A previous history of malignancy excluding basal cell carcinoma of skin History of chemotherapy History of pelvic radiotherapy Inflammatory bowel disease Bilateral hip prothesis Hypersensitivity to FU-5 and its derivatives Hypersensivity reaction to oxaliplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of tumor cells in surgical specimen after treatment. Timepoint: After definitive surgery. Single measurement immediately post surgery. Method of measurement: Examine surgical specimen by pathologist. Categorize as present? absent.;Based on type of surgery (APR vs LAR) and sphincter function. Variable type: categorical (preserved/not preserved). Role: dependent. Timepoint: At the time of surgery: single assessment. Method of measurement: Record type of surgery (APR or LAR) categorize as preserved? not preserved. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS). Timepoint: From diagnosis to last follow up or death. Follow up: up to 5 years post treatment. Method of measurement: Record diagnosis date and date of death or last follow up. Calculate time interval in months.;Disease-Free Survival (DFS). Timepoint: From diagnosis to recurrence, metastasis, or death. Follow up: up to 5 years post treatment. Method of measurement: Record diagnosis date and date of recurrence, metastasis, or death. Calculate time interval in months.;Local Recurrence and Distant Metastasis. Timepoint: Annual CT scans and colonoscopy every 5 years. Tumor markers: every 3 months in first 2 years, every 6 months in years 3–5, then annually. Method of measurement: Assess via CT scans and colonoscopy. Categorize as present? absent. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Taheri
Sabzevar University of Medical Sciences
Outcome results
None listed