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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04764227

Enrollment

Registered

2021-02-21

Start date

2020-05-30

Completion date

2027-03-30

Last updated

2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemoradiotherapy, Esophageal Squamous Cell Carcinoma, Esophagus Cancer, Postoperative, Radiation Therapy

Brief 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.

Interventions

DRUGCarboplatin

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

RADIATIONRadiotherapy

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

DRUGPaclitaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Local control rate	2 years

Secondary

Measure	Time frame
Overall survival	5 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026