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About
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas.
PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.
Full description
OBJECTIVES:
OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified according to clinical center.
Newly diagnosed patients (Study 1)
Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II):
Recurrent tumor patients (Study 2)
Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection are performed.
Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until death or for 1 year after study closure.
PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will be accrued within 4.5 years (Study 2)
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma
Suitable for radical resection on the basis of imaging studies
Patients with recurrent disease must have failed surgery and radiotherapy
PATIENT CHARACTERISTICS:
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Recurrent tumor:
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PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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Data sourced from clinicaltrials.gov
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