NCT02356406

Celiac Plexus Radiosurgery for Pain Management

Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

Detailed description

This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment. The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment. The treatment duration is one and a half weeks (5 fractions delivered every other weekday).

Conditions

• Digestive System Neoplasms

Interventions

Type	Name	Description
RADIATION	Celiac Plexus Radiosurgery	5 fractions of SBRT (Stereotactic body radiation therapy). The target will always include the anterior-medial aspect aorta at T12-L2 (surrogate for celiac plexus). If there is adjacent tumor (e.g. pancreatic tumor that infiltrates the celiac plexus) this will be irradiated in addition. It is expected that patients will be treated with a rapid-arc IMRT (Intensity modulation radiation therapy) dose-painting technique. Details of beam arrangement and energy used will be determined on an individual basis.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2015-02-05
• Last updated: 2015-02-06

Locations

1 site across 1 country: Israel