drugset / Trial / NCT01283178

Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

NCT01283178 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer

Timeline

Start
2011-07
Primary completion
2016-03
Completion
2016-09

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated. The data analysis was futile with only 3 accruals. PI opted to terminate with IRB and withdraw FDA IND.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified — Intravenous