Stage III Rectal Cancer. Malignant neoplasm of rectum
Conditions
Interventions
Intervention 1: Intervention group:(Chemotherapy + Chemoradiotherapy + Chemotherapy):Initial Neoadjuvant Chemotherapy: Patients will receive 4 cycles of the mFOLFOX6 chemotherapy regimen every two wee
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient must be at least 18 years old and no older than 75 years old at the time of obtaining informed consent. Histologically confirmed rectal adenocarcinoma. Clinically staged Stage III tumor (anyTN1-3M0) as determined by transrectal ultrasound or computed tomography or magnetic resonance imaging before surgery. The tumor location is either Ra (rectal segment between the second sacral joint and the peritoneal reflection) or Rb (rectal segment below the peritoneal reflection).4. The patient's ECOG Performance Status is zero or one. The diagnosis of lymph node status around the tumor should be confirmed by a radiologist based on ultrasound or magnetic resonance imaging (MRI or EUS). Evidence of preserved organ function in the 14 days prior to study enrollment is required, including the following:1. white blood cell, neutrophil, and platelet counts in the peripheral blood of = 3000, = 1500, and = 100,000/m2, respectively2. serum total bilirubin, aspartate transaminase, alanine transaminase, and creatinine levels of = 2.0 mg/dL, = 100 IU/L, = 100 IU/L, and = 1.5 mg/dL, respectively
Exclusion criteria
Exclusion criteria: Patients with a history of colorectal cancer or any other cancer in the past 5 years (except intramucosal carcinoma) will be excluded from the study. Patients with metastases will be excluded from the study. Patients who are pregnant, breastfeeding, or have peripheral neuropathy, severe diseases related to body organs (such as severe heart, liver, or kidney diseases, etc.), severe infectious disease, and mental disorder will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be pathological complete response. Timepoint: After the study is completed, it will be evaluated by a specialist physician at the Cancer Center of Imam Khomeini Hospital. Method of measurement: Based on the degree of lymphovascular invasion, tumor location, tumor grade, and MSI. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Mofatteh
Mazandaran University of Medical Sciences
Outcome results
None listed