NRGF-001
Terminated
Protocol Information
Activity Monitoring To Improve Patient Care During Chemoradiotherapy For Locally Advanced Non-small Cell Lung Cancer (La-nsclc)
Principal Investigator
Status
Terminated
Date Opened To Accrual
September 1, 2023
Date Closed To Accrual
August 12, 2024
Date of Study Termination
August 12, 2024
Disease Site
Lung [LU] Non-small Cell Lung Cancer
Phase
I
Developmental Therapeutics
No
Primary Objective
To demonstrate that monitoring daily step counts during a
course of concurrent chemoradiotherapy for locally advanced non-small cell lung
cancer will enable clinicians to deliver improved supportive care and reduce
the rate of adverse clinical events during the radiotherapy course.
Patient Registration Portal
Click here to be redirected to the Patient Registration Portal for this study. Sites will need to access this link to register patients.
Patient Population
Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy. Expected treatment scenarios include:
∙ Definitive treatment of stage III disease (most common)
∙ Definitive treatment for locoregional recurrence of early-stage disease
∙ Definitive treatment of unresectable stage II disease
∙ Preoperative treatment of stage III disease
∙ Postoperative treatment after incomplete resection (uncommon)
∙ Radical treatment for a patient with advanced/metastatic disease with the goal of achieving long-term thoracic disease control (e.g., oligometastatic disease where metastases are addressed with resection or stereotactic radiotherapy).
- Ambulates independently or with a cane.
Target Accrual
144
- FDA-1572_exp-2025Mar31.pdf
- NRGF-001-Kit_Fitness-Tracker-Request-Form.docx
- NRGF-001-Site-Feasibility-Questionnaire.doc
- NRGF-001-Investigator-Signature-Page-Protocol-v.1.0.docx
- NRGF-001-DTL-DelegationTask-Log.doc
- LC13-English.pdf
- LC13-Spanish-US.pdf
- PASE_Questionnaire.pdf
- pro-ctcae_english.pdf
- pro-ctcae_spanish.pdf
- QLQ-C30-English.pdf
- QLQ-C30-Spanish-US.pdf
- NRGF-001-Training-Attestation-Log-v1.0.doc