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Clinical Trials in China / NCT03840239
Active, not recruiting Phase 2

TNT to Increase the Clinical Complete Response Rate for Distal LARC

NCT03840239 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2018-12-25
Last updated
2023-10-25

Condition(s) studied

Rectal CancerRectal Cancer Stage IIRectal Cancer Stage IIIChemoradiation

Investigational drug(s) / intervention(s)

Capecitabine, Oxaliplatin →External beam radiotherapySurgeryWatch and wait strategy

Capecitabine, Oxaliplatin: Drug: Capecitabine, Oxaliplatin

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

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

Watch and wait strategy: Watch and wait strategy recommendation and discussion for cCR patients

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of clinical complete response — 1.5 year after diagnosis
    Rate of clinical complete response

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

More Sun Yat-sen University trials in China

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Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC Starting soon
BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression Enrolling by invitation
Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI Recruiting
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer Recruiting
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer Active, not recruiting
Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy Recruiting
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03840239 on ClinicalTrials.gov ↗ ← All trials in China