Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma

Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02461043

Enrollment

386

Registered

2015-06-03

Start date

2015-04-30

Completion date

2023-12-31

Last updated

2015-09-01

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

Conditions

Esophageal Cancer

Keywords

esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel

Brief summary

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. * Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases. * No standard postoperative adjuvant chemotherapy has ever been established.

Interventions

DRUGpaclitaxel; cisplatin

The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.

RADIATIONradiation

radiation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ability to give informed consent * histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins * node-positive and pathologic stage M0 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients were enrolled 4 to 10 weeks after surgery * Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits

Exclusion criteria

* prior chemotherapy or concurrent radiation therapy before esophagectomy * R1 or R2 resection * clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

Design outcomes

Primary

Measure	Time frame
3 year relapse free survival	5 years

Secondary

Measure	Time frame
3 year overall survival	5 years

Other

Measure	Time frame
5 year overall survival	8 years

Countries

China

Contacts

Primary ContactJing Huang

8610-87788102

Outcome results

None listed

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