Rectal cancer. Malignant neoplasm of rectum
Conditions
Interventions
Intervention 1: Intervention group: The intervention group will include patients who have all chemotherapy sessions before surgery, 3 sessions before radiotherapy and 3 sessions after radiotherapy. Me
preoperative chemoradiation and postoperative chemotherapy. Capecitabin is prescribed at a dose of 825 mg /m2 during radiotherapy, and after surgery, chemotherapy includes oxaliplatin 135 mg / m2, d1
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients with pathologically confirmed rectal cancer who are in locally advanced stage based on imaging
Exclusion criteria
Exclusion criteria: Patients diagnosed with Renal disease who are not candidates for chemotherapy or need to adjust the dose Patients diagnosed with hepatic disease who are not candidates for chemotherapy or need to adjust the dose Patients diagnosed with Cardiovascular disease who are not candidates for chemotherapy Patients with underlying colorectal disease such as Crohn's disease or ulcerative collitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete response to treatment. Timepoint: Before the surgery. Method of measurement: Based on preoperative history, examination and imaging.;Pathologic Complete response to treatment. Timepoint: After the surgery. Method of measurement: Based on the surgical pathology report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Age. Timepoint: Before the intervention. Method of measurement: Asking the patient, patient ID card.;Sex. Timepoint: Before the intervention. Method of measurement: Patient ID card.;Performance. Timepoint: Before the intervention. Method of measurement: Based on Eastern Cooperative Oncology Group criteria.;Hematologic disorders. Timepoint: Before the intervention, weekly during chemotherapy and radiotherapy, and after treatment. Method of measurement: Complete blood count test.;Gastrointestinal side effects. Timepoint: Weekly during chemotherapy and radiotherapy. Method of measurement: Asking the patient, according to the Common Terminology Criteria for Adverse Events.;Neuropathic complications. Timepoint: Weekly during chemotherapy and radiotherapy. Method of measurement: Asking the patient, according to the Common Terminology Criteria for Adverse Events.;Staging of the disease. Timepoint: Before the intervention. Method of measurement: Based on endosonogeraphy or MRI.;Tumor distance from anal verge. Timepoint: Before the intervention. Method of measurement: Based on colonoscopy or endosonogeraphy or MRI.;Chemotherapy regimen. Timepoint: Before the chemotherapy. Method of measurement: Patient's file.;Radiotherapy technique. Timepoint: Before the radiation therapy. Method of measurement: Patient's file.;Radiotherapy dose. Timepoint: Before the treatment. Method of measurement: Patient's file.;Concurrent chemotherapy with radiotherapy. Timepoint: Before the treatment. Method of measurement: Patient's file.;Number of days between the last session of neoadjuvant treatment to surgery. Timepoint: Between the last session of neoadjuvant treatment to surgery. Method of measurement: Patient's file.;Number of days between the surgery to adjuvant treatment. Timepoint: Between the surgery to adjuvant treatment. Method of measurement: Patient's file.;Type of the surgery Low anterior resection or Abdominoperineal resection. Timepoint: After the surgery. Method of measurement: Pa | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahsa Moshtaghian
Tehran University of Medical Sciences
Outcome results
None listed