Cancer of the large intestine. Malignant neoplasm of colon
Conditions
Interventions
Intervention 1: Intervention group: performing 6 week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks. Intervention 2: Control group: Initial su
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adnocarcinoma Stage T3 with lymph node involvement and T4 Non metastatic Primary tumor without complications which needs surgery (i.e. obstruction, perforation, bleeding) Age between 18-75 Functional status ECOG between 0-1
Exclusion criteria
Exclusion criteria: Contraindication for receiving contrast for imaging Major surgery in less than 28 days prior to recruiting to the study Co-existence of other cancers Past medical history of other cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival. Timepoint: One year after intervention. Method of measurement: No relapse of cancer.;Histological response and down staging of tumor. Timepoint: After surgery. Method of measurement: Pathological and radiological examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival. Timepoint: 1 year after surgery. Method of measurement: The patient is alive.;The safety and tolerably of chemotherapy before surgery. Timepoint: 60-day mortality after surgery. Method of measurement: The patient is alive.;Quality of life. Timepoint: At baseline, 6 months and one year after the completion of the study. Method of measurement: ?Questionnaires EORTC QLQ-CR29 and EORTC QLQ-C30. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohamad Moeini
Mashhad University of Medical Sciences
Outcome results
None listed