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NCT03840239Active, not recruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 25 Oct 2023

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
98 (estimated)
First submitted
28 Jan 2019
Start date
Dec 2018
Primary completion date
Dec 2023
Lead sponsor
Sun Yat-sen University
NCT number
NCT03840239

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 98
  • From Dec 2018 to the primary completion date, Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contra indication for chemotherapy and/or radiotherapy
  • Previous pelvic radiotherapy or chemotherapy

Other illness

  • Certain or suspicious allergy to research drug
  • 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 )

Lab values

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

Other

  • Distant metastasis
  • Chronic intestinal inflammation and/or bowel obstruction
  • Peripheral neuropathy \> grade 1
  • Pregnant or breast-feeding woman
  • Cachexia, organ dysfunction
  • Uncontollable severe hypertesion
  • Persons deprived of liberty or under guardianship
  • Impossibility for compliance to follow-up

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status		GuangzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.