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IRCT20220723055527N1 IRCT 2022-11-07 Mashhad University of Medical Sciences The effectiveness of the total neoadjuvant therapy in in rectal adenocarcinoma patients A clinical trial to compare the effectiveness of the total neoadjuvant therapy with standard approach in rectal adenocarcinoma patients 2022-12-11 anticipated 60 Complete https://irct.ir/trial/65666 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of block randomization base on statistical analysis system (SAS), computer software. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed, Blinding description: The data analyzer does not know which groups are located. The statistician will receive questionnaires as anonymously and in form A and B, and he/she does not know which are received the total neoadjuvant therapy or standard approach. 1-2 Rectal adenocarcinoma. Intervention 1: Intervention group: The intervention group will first receive neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then neoadjuvant chemotherapy with FOLFOX or CapOx regimen, and finally definitive surgery. Intervention 2: Control group: The control group will receive standard treatment in the form of neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then definitive surgery and finally adjuvant chemotherapy with FOLFOX or CapOx regimen. Yes - There is a plan to make this available What will be shared: In our study none of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Fereshteh Foroughi Pordanjani provides the data analysis to the applicants via email: foroughifrshte@gmail.com How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Fereshteh Foroughi Pordanjani
Omid Hospital, Al-Nandasht Square, Kooh Sangi Street
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3833 0626 foroughifrshte@gmail.com Mashhad University of Medical Sciences scientific Fereshteh Foroughi Pordanjani
Omid Hospital, Al-Nandasht Square, Kooh Sangi Street
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3833 0626 foroughifrshte@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with rectal adenocarcinoma based on pathological diagnosis The zero to two level of Eastern Cooperative Oncology Group (ECOG) Healthy functioning bone marrow Healthy functioning liver Healthy functioning kidneys no limit no limit Both Having simultaneous adenocarcinoma in other areas of the colon Having metastasis History of previous malignancy History of chemotherapy History of pelvic radiotherapy Having inflammatory intestinal disease Having bilateral hip prosthesis Having allergic to 5-fluorouracil and its other derivatives Having allergic to oxaliplatin C20 Malignant neoplasm of rectum Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will first receive neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then neoadjuvant chemotherapy with FOLFOX or CapOx regimen, and finally definitive surgery. Control group: The control group will receive standard treatment in the form of neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then definitive surgery and finally adjuvant chemotherapy with FOLFOX or CapOx regimen. The pathological complete response. Timepoint: One week after surgery. Method of measurement: Based on surgical pathology report. Local recurrence. Timepoint: One year after intervention. Method of measurement: Pelvic computed tomography (CT) scan and colonoscopy. Distant metastasis. Timepoint: One year after intervention. Method of measurement: Abdominal and pelvic CT scan. Complications of treatment. Timepoint: One, two and three weeks after treatment. Method of measurement: Based on the Common Terminology Criteria for Adverse Events (CTCAE). Sabzevar University of Medical Sciences Mashhad University of Medical Sciences Sabzevar University of Medical Sciences Approved 2022-04-19 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of) Approved 2023-12-12 Research Ethics Committees of Sabzevar University of Medical Sciences Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology Sabzevar Razavi Khorasan Iran (Islamic Republic of)