NCT03258671

IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer

IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer: Results of a Randomised,Openlabel,Multicentre Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: LuBing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment. In this study, the investigators aim to verify the following hypothesis: * whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy, Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung recurring or progressing similarily. * Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal tissue dose/volume tolerance than concurrent regimen. * the survival can be improved by using this new molecular Target-radiotherapy method.

Conditions

• Non-Small Cell Lung Cancer
• Nonsmall Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	EGFR-TK Inhibitor	·EGFR-TKI：gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;
RADIATION	Intensity Modulated Radiation Therapy	High dose group：DTGTV=70Gy； * first course radiotherapy：40Gy/20f/4w（DTPTV：36Gy/20f/4w）,2Gy/f/d； * late course radiotherapy：1.5Gy/f、2f/d、interval≥6 hs、DTGTV=30Gy（DTPTV=27Gy）。 Low dose group：DTGTV=50Gy; * first course radiotherapy：32Gy/16f/3w（DTPTV为28.8Gy/16f/3w），2Gy/f/d； * late course radiotherapy：1.5Gy/f、2f/d、interval≥6小时、DTGTV为18Gy（DTPTV为16.2Gy）。

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2017-08-23
• Last updated: 2017-08-25

Locations

1 site across 1 country: China