NCT00686114

Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.

Detailed description

For the esophageal carcinoma in II\~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	135mg/m2, day 1 and day 29 of the radiotherapy.
DRUG	Cisplatin	20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
DRUG	Tarceva	150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
RADIATION	Radiotherapy	Enlarged field radiotherapy
RADIATION	Radiotherapy	Conventional field radiotherapy

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2008-05-29
• Last updated: 2014-04-29

Locations

1 site across 1 country: China