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

T

Tehran University of Medical Sciences

Status

Not yet enrolling

Conditions

Locally Advanced Rectal Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05920928
IR.TUMS.IKHC.REC. 9911880002

Details and patient eligibility

About

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.

Enrollment

114 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

Long course chemoRadiotherapy (50.4Gy in 28 fr)
Experimental group
Description:
Neoadjuvant Long course radiotherapy (50.4 Gy in 28 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer
Treatment:
Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2)
Short course chemoRadiotherapy (25Gy in 5 fr)
Experimental group
Description:
Neoadjuvant short course radiotherapy (25 Gy in 5 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer
Treatment:
Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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