Protocol summary
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Study aim
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To compare the effectiveness of the total neoadjuvant therapy with standard approach in rectal adenocarcinoma patients
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Design
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This randomized and single-blind clinical trial with parallel and control groups will be conducted on 60 patients who will be randomly selected using the blocks.
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Settings and conduct
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Patients with rectal adenocarcinoma referring to Omid and Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: 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.
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Intervention groups
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In the intervention group, the patient will receive neoadjuvant treatment with pelvic radiotherapy along with capecitabine capsule, then neoadjuvant chemotherapy with FOLFOX or CapOx regimen, and finally definitive surgery.
In the control group, the patient will undergo standard treatment in the form of first neoadjuvant treatment by pelvic radiotherapy with capecitabine capsules, then definitive surgery and finally adjuvant chemotherapy with FOLFOX or CapOx regimen.
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Main outcome variables
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Evaluation and comparison of the pathological complete response, local recurrence and distant metastasis
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220723055527N1
Registration date:
2022-11-07, 1401/08/16
Registration timing:
prospective
Last update:
2024-01-02, 1402/10/12
Update count:
1
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Registration date
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2022-11-07, 1401/08/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-11, 1401/09/20
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Expected recruitment end date
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2023-09-22, 1402/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A clinical trial to compare the effectiveness of the total neoadjuvant therapy with standard approach in rectal adenocarcinoma patients
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Public title
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The effectiveness of the total neoadjuvant therapy in in rectal adenocarcinoma patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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No age limit
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-04-19, 1401/01/30
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1401.053
2
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Ethics committee
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Approval date
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2023-12-12, 1402/09/21
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Ethics committee reference number
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IR.MEDSAB.REC.1402.089
Health conditions studied
1
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Description of health condition studied
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Rectal adenocarcinoma
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ICD-10 code
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C20
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ICD-10 code description
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Malignant neoplasm of rectum
Primary outcomes
1
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Description
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The pathological complete response
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Timepoint
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One week after surgery
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Method of measurement
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Based on surgical pathology report
2
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Description
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Local recurrence
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Timepoint
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One year after intervention
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Method of measurement
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Pelvic computed tomography (CT) scan and colonoscopy
3
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Description
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Distant metastasis
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Timepoint
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One year after intervention
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Method of measurement
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Abdominal and pelvic CT scan
Secondary outcomes
1
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Description
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Complications of treatment
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Timepoint
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One, two and three weeks after treatment
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Method of measurement
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Based on the Common Terminology Criteria for Adverse Events (CTCAE)
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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A clinical Trial on the frequency of pathologic complete response in total neoadjuvant treatment in comparison with standard approach in patients with rectal adenocarcinoma
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Grant code / Reference number
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۴۰۲۰۴۹
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sabzevar University of Medical Sciences
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Proportion provided by this source
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50
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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6 months after publishing the results
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To whom data/document is available
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The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
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Under which criteria data/document could be used
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The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
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From where data/document is obtainable
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Fereshteh Foroughi Pordanjani provides the data analysis to the applicants via email: foroughifrshte@gmail.com
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What processes are involved for a request to access data/document
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Applicants can send emails to him and receive a response within a week.
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Comments
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