Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision.

External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.

Capecitabine, Oxaliplatin

External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume

External beam radiotherapy

'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries

Surgery

Watch and wait strategy recommendation and discussion for cCR patients

Watch and wait strategy

WeiWei Xiao

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.

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.

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)

Number of patients with sphincter preservation through Watch and wait strategy, or local excision, or intersphincter resection, or low anterior resection, etc.

Rate of pathological complete response and tumor regression grade distribution

Long-term anal function according to Wexner Continence Grading Scale

Long-term toxicity grading according to CTCAE 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TNT to Increase the Clinical Complete Response Rate for Distal LARC	NCT03840239	Rectal Cancer Rectal Cancer S... Rectal Cancer S... Chemoradiation	Capecitabine, O... External beam r... Surgery Watch and wait ...	18 Years - 70 Years	Sun Yat-sen University
TNT to Increase the Clinical Complete Response Rate for Distal LARC	NCT03840239	Rectal Cancer Rectal Cancer S... Rectal Cancer S... Chemoradiation	Capecitabine, O... External beam r... Surgery Watch and wait ...	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for watch and wait strategy