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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000587517 | Registry Identifier | PDQ (Physician Data Query) |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.
PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3 months after completion of study treatment.
After completion of study treatment, patients are followed periodically for at least 4 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indinavir sulfate | Drug | |||
| ritonavir | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure in the brain (TTF) as determined by the radiological response rate | ||
| Overall survival (OS) | ||
| Radiological volumetric response to treatment | ||
| Local intracranial disease progression at 4 months | ||
| Progression-free survival at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of symptoms | ||
| Time to symptom relapse or symptom progression | ||
| Duration of use of steroids |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic cancer with brain metastases
All cancer types allowed, except for the following:
Measurable disease by MRI of the brain
Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ilja Ciernik, MD | Oncology Institute of Southern Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cantonal Universitaire de Geneve | Recruiting | Geneva | CH-1211 | Switzerland |
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| Duration of use of anticonvulsive drugs |
| Oncology Institute of Southern Switzerland - Lugano | Recruiting | Lugano | CH-6900 | Switzerland |
|
| UniversitaetsSpital Zuerich | Recruiting | Zurich | CH-8091 | Switzerland |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001932 | Brain Neoplasms |
| D018268 | Adrenocortical Carcinoma |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D001005 | Anus Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D001943 | Breast Neoplasms |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D003110 | Colonic Neoplasms |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D004938 | Esophageal Neoplasms |
| D018304 | Esthesioneuroblastoma, Olfactory |
| D018263 | Adenocarcinoma, Follicular |
| D013274 | Stomach Neoplasms |
| D008224 | Lymphoma, Follicular |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D009303 | Nasopharyngeal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009959 | Oropharyngeal Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010190 | Pancreatic Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| D010412 | Penile Neoplasms |
| D011471 | Prostatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D012468 | Salivary Gland Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D016889 | Endometrial Neoplasms |
| D014846 | Vulvar Neoplasms |
| D009396 | Wilms Tumor |
| D002583 | Uterine Cervical Neoplasms |
| D014625 | Vaginal Neoplasms |
| D051677 | Histiocytoma, Malignant Fibrous |
| D010282 | Parathyroid Neoplasms |
| D010673 | Pheochromocytoma |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016399 | Lymphoma, T-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D009447 | Neuroblastoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D020431 | Olfactory Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D013272 | Stomach Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D013964 | Thyroid Neoplasms |
| D013959 | Thyroid Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D010409 | Penile Diseases |
| D011469 | Prostatic Diseases |
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D012466 | Salivary Gland Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D014845 | Vulvar Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002577 | Uterine Cervical Diseases |
| D014623 | Vaginal Diseases |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D010279 | Parathyroid Diseases |
| D010235 | Paraganglioma |
| D018358 | Neuroendocrine Tumors |
| D014060 | Tongue Diseases |
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| ID | Term |
|---|---|
| D019469 | Indinavir |
| D019438 | Ritonavir |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D013812 | Therapeutics |
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