Clinical Trials Logo

Clinical Trial Summary

Phase I of the study (motion and quality assurance [QA] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.


Clinical Trial Description

Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study.

Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:

Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = <50% CTV dose/No previous RT = <80% CTV dose.

Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.

# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.

*Previous RT:

- greater than six months since completion of RT

- at least 20 Gy, but no more than 50 Gy ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00573872
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Completed
Phase N/A
Start date April 2005
Completion date September 2016

See also
  Status Clinical Trial Phase
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT00199836 - A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer. Phase 1
Completed NCT01672944 - Evaluating Biobanking Educational Tools N/A
Not yet recruiting NCT02226289 - Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment Phase 2
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Completed NCT02746185 - Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban Phase 3
Completed NCT02747342 - A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer Phase 1
Completed NCT02536586 - A Study of LY3023414 in Japanese Participants With Advanced Cancer Phase 1
Completed NCT02309164 - The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN). N/A
Completed NCT02394821 - Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide Phase 3
Completed NCT01457196 - Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions N/A
Completed NCT00143533 - Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors Phase 1
Recruiting NCT05450562 - Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT00001835 - Oxaliplatin in Cancer Patients With Impaired Kidney Function Phase 1
Completed NCT00001341 - A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease Phase 1
Completed NCT01425008 - Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma Phase 1
Recruiting NCT05101798 - The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial Phase 2
Completed NCT01920061 - A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) Phase 1
Terminated NCT03251924 - A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT02851706 - Natural History of and Specimen Banking for People With Tumors of the Central Nervous System