NCT01470365

3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors

Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of 3-dimensional conformal radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Palliative radiation therapy may help patients with recurrent tumors live more comfortably.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique. SECONDARY OBJECTIVES: I. To investigate the dosimetric tolerance of normal structures to reirradiation with the pulsed low dose rate technique. II. To determine the palliative efficacy and quality of life in patients treated on this protocol. III. To determine duration of response and time to progression. OUTLINE: This is a dose-escalation study. Patients undergo 3-dimensional CRT or IMRT once daily (QD), 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every month for 6 months and then every 12 weeks thereafter.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	quality-of-life assessment	Ancillary studies
RADIATION	intensity-modulated radiation therapy	Undergo IMRT
RADIATION	3-dimensional conformal radiation therapy	Undergo 3-dimensional CRT

Timeline

• Start date: 2011-11-03
• Primary completion: 2015-08-31
• Completion: 2019-02-21
• First posted: 2011-11-11
• Last updated: 2020-05-08

Locations

1 site across 1 country: United States