Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer

Study Overview
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Brief Summary
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Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.

Official Title
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Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial

Conditions
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Locally Advanced Rectal Carcinoma

Intervention / Treatment
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* Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2)
* Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge . Exclusion Criteria: Familial syndromes e.g. lynch Previous history of cancer Previous history of chemotherapy Recurrent disease Metastatic disease Inability to perform MRI (Claustrophobia or prosthetic valve)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long course chemoRadiotherapy (50.4Gy in 28 fr)<br>Neoadjuvant Long course radiotherapy (50.4 Gy in 28 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer | Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2)<br>* Long-term radiation is administered in conjunction with concomitant capecitabine (825mg/m2)<br>* Other names: Long term radiotherapy (50.4Gy in 28Fr);|
| Experimental: Short course chemoRadiotherapy (25Gy in 5 fr)<br>Neoadjuvant short course radiotherapy (25 Gy in 5 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer | Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2)<br>* Compared to conventional treatments, short-term radiotherapy has lower fraction numbers but higher radiation doses per fraction. capecitabine is given during treatment time (825mg/m2)<br>* Other names: Short term radiotherapy (25Gy in 5Fr);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical complete response | At the 18th week following the start of the treatment, the patient will be assessed. The evaluation consist of an MRI and a colonoscopy, with a PET scan being optional. | Week |