Clinical trial · Interventional
Establishing Best Treatment Strategy for T4 Esophageal Cancer
A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
- 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)
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are: * Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate? * Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer. Participants will: * Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3 * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer TNM Staging Primary Tumor (T) T4 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Docetaxel", "Cisplatin", "fluorouracil", "Radiation" | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy followed by chemoradiotherapy
- description
- This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy.
- interventionNames
- Combination Product: "Docetaxel", "Cisplatin", "fluorouracil", "Radiation"
Primary outcomes (2)
- measure
- Overall response rate of the treatment
- timeFrame
- At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
- description
- Overall response rate = complete response (CR) rate + partial response (PR) rate.
- measure
- Duration of response (DOR)
- timeFrame
- At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed esophageal squamous cell carcinoma 2. Tumor or lymph nodes invade adjacent organs (T4 stage) 3. Aged between 18-70 years old 4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2 5. Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10\^3/L, platelet count ≥ 100×10\^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min. Exclusion Criteria: 1. Previous chemotherapy history 2. Myocardial infarction within the last three months 3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema 4. Has other malignancies currently 5. Uncontrolled infection 6. Pregnancy or lactation 7. Perforated esophagus at the time of diagnosis
References
Publications (3)
- BACKGROUNDChan WL, Choi CW, Wong IY, Tsang TH, Lam AT, Tse RP, Chan KK, Wong C, Law BT, Cheung EE, Chan SY, Lam KO, Kwong D, Law S. Docetaxel, Cisplatin, and 5-FU Triplet Therapy as Conversion Therapy for Locoregionally Advanced Unresectable Esophageal Squamous Cell Carcinoma. Ann Surg Oncol. 2023 Feb;30(2):861-870. doi: 10.1245/s10434-022-12694-8. Epub 2022 Oct 28. PMID 36307666
- BACKGROUNDSatake H, Tahara M, Mochizuki S, Kato K, Hara H, Yokota T, Kiyota N, Kii T, Chin K, Zenda S, Kojima T, Bando H, Yamazaki T, Iwasa S, Honma Y, Hamauchi S, Tsushima T, Ohtsu A. A prospective, multicenter phase I/II study of induction chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma. Cancer Chemother Pharmacol. 2016 Jul;78(1):91-9. doi: 10.1007/s00280-016-3062-2. Epub 2016 May 18. PMID 27193097
- BACKGROUNDMakino T, Yamasaki M, Miyazaki Y, Wada N, Takahashi T, Kurokawa Y, Nakajima K, Takiguchi S, Mori M, Doki Y. Utility of initial induction chemotherapy with 5-fluorouracil, cisplatin, and docetaxel (DCF) for T4 esophageal cancer: a propensity score-matched analysis. Dis Esophagus. 2018 Apr 1;31(4). doi: 10.1093/dote/dox130. PMID 29190316