NCT03840239

TNT to Increase the Clinical Complete Response Rate for Distal LARC

Total Neoadjuvant trEatment to Increase the Clinical Complete reSponse Rate for diStal Locally Advanced Rectal Cancer (TESS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.

Detailed description

Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate. The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.

Conditions

• Rectal Cancer
• Rectal Cancer Stage II
• Rectal Cancer Stage III
• Chemoradiation

Interventions

Type	Name	Description
DRUG	Capecitabine, Oxaliplatin	Drug: Capecitabine, Oxaliplatin
RADIATION	External beam radiotherapy	External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume
PROCEDURE	Surgery	'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries
OTHER	Watch and wait strategy	Watch and wait strategy recommendation and discussion for cCR patients

Timeline

• Start date: 2018-12-25
• Primary completion: 2023-12-30
• Completion: 2027-06-30
• First posted: 2019-02-15
• Last updated: 2023-10-25

Locations

1 site across 1 country: China