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IRCT20130819014404N2 IRCT 2018-12-12 Mashhad University of Medical Sciences Chemotherapy in locally advanced colon cancer Neoadjuvant chemotherapy in locally advanced colon cancer: a randomized controlled trial 2018-11-30 anticipated 58 Complete https://irct.ir/trial/35601 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization on individuals was performed using a table of random numbers. Allocation concealment was carried out, Blinding description: The surgeon, pathologist and radiologist are unaware of allocated groups. Besides, the outcome assessor who evaluates the quality of life is unaware of the allocated groups. The data analyser will be blinded to the intervention groups. 3 Cancer of the large intestine. 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 surgery followed by chemotherapy with mFOLFOX 6 or CapeOx for 24 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohamad Moeini
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 moeininm901@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Baari
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3801 2742 baria@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 75 years Both 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 C18 Malignant neoplasm of colon Treatment - Drugs Treatment - Drugs Intervention group: performing 6 week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks Control group: Initial surgery followed by chemotherapy with mFOLFOX 6 or CapeOx for 24 weeks Histological response and down staging of tumor. Timepoint: After surgery. Method of measurement: Pathological and radiological examination. Disease Free Survival. Timepoint: One year after intervention. Method of measurement: No relapse of cancer. 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: Ù‹Questionnaires EORTC QLQ-CR29 and EORTC QLQ-C30. Mashhad University of Medical Sciences Approved 2018-07-25 Ethics Committee of Medical Faculty of Mashhad University of Medical Sciences Medical Faculty, University Campus, Azadi Sq., Mashhad Razavi Khorasan Iran (Islamic Republic of)