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Trial Title:
Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer
NCT ID:
NCT05920928
Condition:
Locally Advanced Rectal Carcinoma
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Short course radiotherapy with concurrent capecitabine(825mg/m2)
Description:
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)
Arm group label:
Short course chemoRadiotherapy (25Gy in 5 fr)
Other name:
Short term radiotherapy (25Gy in 5Fr)
Intervention type:
Radiation
Intervention name:
Long course radiotherapy with concurrent capecitabine(825mg/m2)
Description:
Long-term radiation is administered in conjunction with concomitant capecitabine
(825mg/m2)
Arm group label:
Long course chemoRadiotherapy (50.4Gy in 28 fr)
Other name:
Long term radiotherapy (50.4Gy in 28Fr)
Summary:
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
September 23, 2023
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Tehran University of Medical Sciences
Agency class:
Other
Source:
Tehran University of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05920928
