NCT03328234

Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03

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 Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.

Conditions

• IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Interventions

Type	Name	Description
RADIATION	SIB-IMRT	Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
DRUG	Paclitaxel	45-50mg/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	135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
DRUG	Platinum-Based Drug	Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
OTHER	Involved Field Irradiation (IFI)	CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.

Timeline

• Start date: 2017-09-01
• Primary completion: 2021-08-31
• Completion: 2022-12-31
• First posted: 2017-11-01
• Last updated: 2019-01-02

Locations

1 site across 1 country: China