NCT02403531

Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

A Phase II Randomized Trial of Induction Chemotherapy Versus no Induction Chemotherapy Followed by Definitive Chemoradiotherapy in Patients With Inoperable Thoracic Esophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Mian XI · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.

Detailed description

108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel	Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
DRUG	Cisplatin	Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
RADIATION	Radiotherapy	definitive radiotherapy

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-09-06
• Completion: 2020-05-30
• First posted: 2015-03-31
• Last updated: 2020-06-02

Locations

1 site across 1 country: China