Phase III Study of Individualized Adaptive Radiotherapy Based on PET/CT and 3DCRT/IMRT in Combination With Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Shandong Cancer Hospital and Institute24 sites in 1 country400 target enrollmentMay 2015

ConditionsLung Neoplasms

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Lung Neoplasms
Sponsor: Shandong Cancer Hospital and Institute
Enrollment: 400
Locations: 24
Primary Endpoint: Overall survival
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a perspective, multicenter,randomized controlled trial to compare the efficacy and safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS) will be done as defined in the protocol.

Detailed Description

https://register.clinicaltrials.gov/prs/app/template/Home.vm?uid=U000184Z\&ts=76\&sid=S0006AP2\&cx=r0ratc

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

December 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Cancer Hospital and Institute

Responsible Party

Principal Investigator

Jinming Yu

president

Shandong Cancer Hospital and Institute

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically proven non-small cell lung cancer.
•Patients must be clinical AJCC stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multidisciplinary treatment team.
•Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
•Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
•History/physical examination, including documentation of weight, within 2 weeks prior to registration;
•CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration;
•CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration;
•Pulmonary function tests, including DLCO, within 6 weeks prior to registration; patients must have FEV1 ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
•Zubrod Performance Status 0-1 within 2 weeks prior to registration;
•Able to tolerate PET/CT imaging required to be performed at an ACR Imaging Core Lab qualified facility;