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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    98
  • sponsor
    Sun Yat-sen University
Updated on 13 October 2022
obstruction
metastasis
oxaliplatin
capecitabine
adenocarcinoma
local excision
pelvic radiation
total mesorectal excision

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.

Details
Condition Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III, Chemoradiation
Treatment Surgery, External Beam Radiotherapy, Capecitabine, Oxaliplatin, Watch and wait strategy
Clinical Study IdentifierNCT03840239
SponsorSun Yat-sen University
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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