Clinical trial · Interventional
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)
NCT03840239CI-TRIAL-00070781TESSactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer Stage II | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer Stage III | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Oxaliplatin | Drug | CAPOX Regimen | ALIAS |
| External beam radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| Watch and wait strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TNT arm
- description
- 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.
- interventionNames
- Drug: Capecitabine, Oxaliplatin
- Radiation: External beam radiotherapy
- Procedure: Surgery
- Other: Watch and wait strategy
Primary outcomes (1)
- measure
- Rate of clinical complete response
- timeFrame
- 1.5 year after diagnosis
- description
- Rate of clinical complete response
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLiu S, Lv G, Xu G, Wang X, Zhuang Y, Bai S, Yu H, Wu X, Ye Y, Luo H, Xu S, Wang Q, Chang H, Cai P, Pan Z, Gao Y, Chen G, Xiao W. Safety and Efficacy of a Sandwich Total Neoadjuvant Therapy Strategy for Low-Risk Distal Locally Advanced Rectal Cancer: Results From the TESS Phase II Trial. MedComm (2020). 2026 Jun 17;7(7):e70807. doi: 10.1002/mco2.70807. eCollection 2026 Jul. PMID 42318526