TNT to Increase the Clinical Complete Response Rate for Distal LARC

Rectal Cancer Clinical Trial

— TESS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03840239
• Other study ID #: 2018-FXY-149
• Secondary ID: 5010-2018-04
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 25, 2018
• Est. completion date: June 30, 2027

Study information

• Verified date: October 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: June 30, 2027
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Rectal adenocarcinoma

• cT3-4aNany or cTanyN+

• Location =5 cm from the anal verge

• No distant metastasis

• No gastrointestinal obstruction or relieved obstruction

• No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy

• ECOG 0-1

• Expected survival length = 2 years

• Age 18-70

• Sufficient bone marrow, kidney and liver function

• Effective contraception during the study

• Patient and doctor have signed informed consent

Exclusion Criteria:

• Distant metastasis

• Chronic intestinal inflammation and/or bowel obstruction

• Contra indication for chemotherapy and/or radiotherapy

• Previous pelvic radiotherapy or chemotherapy

• Severe renal, hepatic insufficiency (serum creatinine<30ml/min)

• Peripheral neuropathy > grade 1

• Pregnant or breast-feeding woman

• Certain or suspicious allergy to research drug

• Cachexia, organ dysfunction

• Active severe infection

• Multiple primary cancers

• Epileptic seizures

• Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma

• Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )

• Uncontollable severe hypertesion

• Persons deprived of liberty or under guardianship

• Impossibility for compliance to follow-up

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical complete response	Rate of clinical complete response	1.5 year after diagnosis
Secondary	Ratio of sphincter preservation strategy	Number of patients with sphincter preservation through Watch and wait strategy, or local excision, or intersphincter resection, or low anterior resection, etc.	1.5 year after diagnosis
Secondary	Rate of pathological complete response and tumor regression grade distribution	Rate of pathological complete response and tumor regression grade distribution	1.5 year after diagnosis
Secondary	Acute toxicity	Acute toxicity according to CTCAE 5.0	Within the first course of anti-tumor treatment
Secondary	Rate of surgical complications	Rate of surgical complications	1.5 year after diagnosis
Secondary	Long-term anal function	Long-term anal function according to Wexner Continence Grading Scale	1.5 year after diagnosis
Secondary	Long-term toxicity grading	Long-term toxicity grading according to CTCAE 5.0	3 year after the end of the first course of anti-tumor treatment
Secondary	ECOG standard score	ECOG standard score	1.5 year after diagnosis
Secondary	3 year disease free survival	3 year disease free survival	3 year after the end of the first course of anti-tumor treatment
Secondary	5 year overall survival	5 year overall survival	5 year after the end of the first course of anti-tumor treatment