Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous C… (NCT02976909) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous Cell Carcinoma
China46 participantsStarted 2016-10
Plain-language summary
This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and 5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients should be voluntary to the trial and provide with signed informed consent.
✓. Male or female patients, age:18-70 years old
✓. Confirmed by histology of thoracic esophageal squamous cell carcinoma without metastasis and diagnosed as boundary resectable by Multidisciplinary consultation, including cT4 and/or bulky lymphadenopathy that may invade nearby organs(such as the great vessels, trachea and heart, etc.)
✓. Measurable or unmeasurable lesions according the RECIST 1.1 criteria.
✓. No previous chemotherapy or radiotherapy.
✓. Life expectancy ≥ 3 months.
✓. ECOG PS 0-1.
✓. Blood routine within 7 days：Hb ≥9g/L，NE ≥1.5×109/L，PLT ≥100×109/L；
Exclusion criteria
✕. Cervical esophageal carcinoma.
✕. Known severe hypersensitivity to drugs in the regimen.
✕. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
✕. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
What they're measuring
1
R0 resection rate
Timeframe: following resection for up to 36 months