NCT03308552

Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.

Conditions

• Esophageal Neoplasms

Interventions

Type	Name	Description
RADIATION	SIB-IMRT	PTV:50.4Gy/28f, PGTV:59.92Gy/28f
DRUG	Paclitaxel	45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
DRUG	Platinum-Based Drug	Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
DRUG	Paclitaxel	150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
DRUG	Platinum-Based Drug	Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-08-30
• Completion: 2021-08-30
• First posted: 2017-10-12
• Last updated: 2019-01-02

Locations

1 site across 1 country: China