Evaluation of the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer

Phase 3

• Conditions: C18.7; Rectal cancer.; Malignant neoplasm of sigmoid colon

• Registration Number: IRCT20120215009014N431
• Lead Sponsor: Hamedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Age 18 to 75 years
Advanced localized rectal cancer
Normal liver, kidney and bone marrow condition

Exclusion Criteria

Previous chemotherapy
Former pelvic radiotherapy
Existence of distant metastasis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of complete pathological response in surgery. Timepoint: 6 to 8 weeks after the end of the intervention. Method of measurement: By pathological evaluation.;Local recurrence rate. Timepoint: Every 3 to 6 months up to 2 years after the end of the intervention. Method of measurement: By measuring tumor marker CEA and colonoscopy and pelvic CT scan.;Presence of distant metastasis. Timepoint: Every 3 to 6 months up to 2 years after the end of the intervention. Method of measurement: By CT scan of the chest and abdomen.;Overall survival rate. Timepoint: Up to 2 years after the end of the intervention. Method of measurement: By taking a history.

Secondary Outcome Measures

Name	Time	Method
Possible acute and chronic hematologic and non-hematologic complications. Timepoint: up to 2 years after the end of the intervention during patient follow-up. Method of measurement: By taking history, clinical examination and blood test.