MedDataX Logo

Definitive Concurrent Chemoradiotherapy With Docetaxel Plus Cisplatin Versus 5-fluorouracil Plus Cisplatin in Patients With Esophageal Squamous Cell Carcinoma

NCT02969473 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-11-21

No results posted yet for this study

Summary

In this phase II study, the investigators aim to evaluated the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with esophageal squamous cell carcinoma (ESCC).

Conditions

  • Esophageal Neoplasm
  • Chemoradiation

Interventions

DRUG

Docetaxel

Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator. Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the DP group received two cycles of DP regimen (docetaxel 60 mg/m2 delivered on day 1 and cisplatin 80 mg/m2 delivered on day 1) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.

DRUG

Fluorouracil

Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator. Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the PF group received two cycles of PF regimen (cisplatin 80 mg/m2 delivered on day 1 and 5-FU 1000 mg/m2 continuous infusion over 24 hours daily on days 1-4) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle.

Sponsors & Collaborators

  • Zhu Yujia

    lead OTHER

Principal Investigators

  • Yonghong Hu, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2016-05-31
Completion
2017-05-31

Countries

  • China

Study Locations

Related Clinical Trials

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969473 on ClinicalTrials.gov