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Clinical Trials in China / NCT04764227
Active, not recruiting Phase 2

Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

NCT04764227 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2020-05-30
Last updated
2023-08-03

Condition(s) studied

Esophagus CancerEsophageal Squamous Cell CarcinomaChemoradiotherapyRadiation TherapyPostoperative

Investigational drug(s) / intervention(s)

PaclitaxelCarboplatinRadiotherapy

Paclitaxel: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw\*5

Carboplatin: carboplatin AUC=2, ivgtt, d1, qw\*5

Radiotherapy: 1.8Gy/d, d1-5/week, 28Fx

Study summary

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Joined the study voluntarily and signed informed consent form; * Age 18-75; * ECOG 0-2; * Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection; * The operative incision healed well; * T3-4N0M0, T1-4N1-3M0 (according to AJCC2009); * No radiotherapy, chemotherapy or other treatments pre (post) surgery; * PS ECOG 0-2; * Life expectancy of more than 3 months; * Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L; * Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN; * Renal function: creatinine \< 1.5 x ULN * No immuno-deficiency; * Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: * Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis; * Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; * Participation in other interventional clinical trials within 30 days; * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; * Drug addiction, Alcoholism or AIDS; * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; * Unsuitable to be enrolled in the trial in the opinion of the investigators.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai China

More Fudan University trials in China

Other trials for the same condition

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 NCT04764227 on ClinicalTrials.gov ↗ ← All trials in China