Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2013-06-30
2017-09-17
Brief Summary
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Detailed Description
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18F-FMISO PET will be performed in 20 patients with diagnosis of HGG: after surgery/biopsy and before radical treatment with 3D radiotherapy and temozolomide. A subset of 10 patients undergo two studies with 18F- FMISO-PET (one with SCS "off" and one with SCS "on"). In these patients, SCS will be connected from 1 hour before to 1 hour after each radiotherapy session, and in the day-time during the days of adjuvant temozolomide.
18F-FMISO PET results will not be taking into account for patient management. Patients will be followed at least until the end of adjuvant temozolomide (6 months after the end of concurrent radiochemotherapy).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm-A: 18F-FMISO-PET without SCS
One 18F-FMISO-PET study for assessment of tumor hypoxia before radiotherapy and Temozolomide, without spinal cord stimulation.
18F-FMISO
18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
PET without SCS
PET-scanning using 18F-fluoromisonidazole without SCS
Radiotherapy
Standard radiation therapy
Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Arm-B: 18F-FMISO-PET without/with SCS
Two 18F-FMISO-PET studies for assessment of tumor hypoxia before radiotherapy and Temozolomide: one "without" and one "with" spinal cord stimulation
18F-FMISO
18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
PET without SCS
PET-scanning using 18F-fluoromisonidazole without SCS
SCS
Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.
PET without/with SCS
Second PET-scanning using 18F-fluoromisonidazole: without/with SCS
Radiotherapy
Standard radiation therapy
Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Interventions
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18F-FMISO
18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
PET without SCS
PET-scanning using 18F-fluoromisonidazole without SCS
SCS
Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.
PET without/with SCS
Second PET-scanning using 18F-fluoromisonidazole: without/with SCS
Radiotherapy
Standard radiation therapy
Temozolomide
Standard treatment with concurrent and adjuvant Temozolomide.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients 18-75 years old.
* Karnofsky \>= 60% and ECOG =\< 2.
* Signed informed consent.
Exclusion Criteria
* Pregnant or breastfeeding women and women of fertile age who are not using a safe contraceptive method or do not intend to use one during the trial. Safe contraceptive methods are oral or parenteral contraceptive treatments or barrier methods: masculine or feminine condom, diaphragm and/or intrauterine device (IUD) or withdrawal over the course of the study.
* Serious co-existing or concurrent illness, including any of the following: uncontrolled or severe infection, heart, liver or kidney disease
* Lung thromboembolism.
* Another malignancy in the last 5 years other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* Patients with life expectancy \<3 months.
* Patients with any of the following: creatinine \> 2 mg/dl, neutrophils \<1.5 \* 10\^9/L, platelets \<100 \* 10\^9/L or hemoglobin \<8.5 g/dL.
* Contraindications to receive radiotherapy or chemotherapy Clinical or psychological contraindications for placement of spinal cord stimulation devices (only for that specific subset of patients).
* Patients who are unable or unwilling to meet the protocol study.
18 Years
75 Years
ALL
No
Sponsors
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Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
UNKNOWN
Instituto de Salud Carlos III
OTHER_GOV
Grupo de Investigación Clínica en Oncología Radioterapia
OTHER
Instituto Canario de Investigación del Cáncer
OTHER
RSbiomed
UNKNOWN
Fundación DISA, Canary Islands, Spain
UNKNOWN
Bernardino Clavo, MD, PhD
OTHER
Responsible Party
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Bernardino Clavo, MD, PhD
Radiation Oncologist, MD, PhD
Principal Investigators
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Bernardino Clavo, MD, PhD
Role: STUDY_CHAIR
Dr. Negrin University Hospital, Las Palmas
Bernardino Clavo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. Negrin University Hospital, Las Palmas
Francisco Robaina, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. Negrin University Hospital, Las Palmas
Juan C Alonso, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Locations
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Dr. Negrin University Hospital
Las Palmas, , Spain
Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid
Madrid, , Spain
Countries
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References
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Clavo B, Robaina F, Morera J, Ruiz-Egea E, Perez JL, Macias D, Carames MA, Catala L, Hernandez MA, Gunderoth M. Increase of brain tumor oxygenation during cervical spinal cord stimulation. Report of three cases. J Neurosurg. 2002 Jan;96(1 Suppl):94-100. doi: 10.3171/spi.2002.96.1.0094.
Clavo B, Robaina F, Catala L, Valcarcel B, Morera J, Carames MA, Ruiz-Egea E, Panero F, Lloret M, Hernandez MA. Increased locoregional blood flow in brain tumors after cervical spinal cord stimulation. J Neurosurg. 2003 Jun;98(6):1263-70. doi: 10.3171/jns.2003.98.6.1263.
Clavo B, Robaina F, Catala L, Perez JL, Lloret M, Carames MA, Morera J, Lopez L, Suarez G, Macias D, Rivero J, Hernandez MA. Effect of cervical spinal cord stimulation on regional blood flow and oxygenation in advanced head and neck tumours. Ann Oncol. 2004 May;15(5):802-7. doi: 10.1093/annonc/mdh189.
Clavo B, Robaina F, Montz R, Domper M, Carames MA, Morera J, Pinar B, Hernandez MA, Santullano V, Carreras JL. Modification of glucose metabolism in brain tumors by using cervical spinal cord stimulation. J Neurosurg. 2006 Apr;104(4):537-41. doi: 10.3171/jns.2006.104.4.537.
Robaina F, Clavo B, Catala L, Carames MA, Morera J. Blood flow increase by cervical spinal cord stimulation in middle cerebral and common carotid arteries. Neuromodulation. 2004 Jan;7(1):26-31. doi: 10.1111/j.1525-1403.2004.04003.x.
Clavo B, Robaina F, Montz R, Carames MA, Otermin E, Carreras JL. Effect of cervical spinal cord stimulation on cerebral glucose metabolism. Neurol Res. 2008 Jul;30(6):652-4. doi: 10.1179/174313208X305373. Epub 2008 May 29.
Clavo B, Robaina F, Montz R, Carames MA, Lloret M, Ponce P, Hernandez MA, Carreras JL. Modification of glucose metabolism in radiation-induced brain injury areas using cervical spinal cord stimulation. Acta Neurochir (Wien). 2009 Nov;151(11):1419-25. doi: 10.1007/s00701-009-0400-8. Epub 2009 Jun 5.
Clavo B, Robaina F, Valcarcel B, Catala L, Perez JL, Cabezon A, Jorge IJ, Fiuza D, Hernandez MA, Jover R, Carreras JL. Modification of loco-regional microenvironment in brain tumors by spinal cord stimulation. Implications for radio-chemotherapy. J Neurooncol. 2012 Jan;106(1):177-84. doi: 10.1007/s11060-011-0660-z. Epub 2011 Jul 12.
Overgaard J. Hypoxic radiosensitization: adored and ignored. J Clin Oncol. 2007 Sep 10;25(26):4066-74. doi: 10.1200/JCO.2007.12.7878.
Spence AM, Muzi M, Swanson KR, O'Sullivan F, Rockhill JK, Rajendran JG, Adamsen TC, Link JM, Swanson PE, Yagle KJ, Rostomily RC, Silbergeld DL, Krohn KA. Regional hypoxia in glioblastoma multiforme quantified with [18F]fluoromisonidazole positron emission tomography before radiotherapy: correlation with time to progression and survival. Clin Cancer Res. 2008 May 1;14(9):2623-30. doi: 10.1158/1078-0432.CCR-07-4995.
Clavo B, Robaina F, Jorge IJ, Cabrera R, Ruiz-Egea E, Szolna A, Otermin E, Llontop P, Carames MA, Santana-Rodriguez N, Sminia P. Spinal cord stimulation as adjuvant during chemotherapy and reirradiation treatment of recurrent high-grade gliomas. Integr Cancer Ther. 2014 Nov;13(6):513-9. doi: 10.1177/1534735414550037. Epub 2014 Sep 15.
Clavo B, Robaina F, Fiuza D, Ruiz A, Lloret M, Rey-Baltar D, Llontop P, Riveros A, Rivero J, Castaneda F, Quintero S, Santana-Rodriguez N. Predictive value of hypoxia in advanced head and neck cancer after treatment with hyperfractionated radio-chemotherapy and hypoxia modification. Clin Transl Oncol. 2017 Apr;19(4):419-424. doi: 10.1007/s12094-016-1541-x. Epub 2016 Aug 15.
Other Identifiers
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2009-015852-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PI 06/1413, PI 12/02940
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TC-FMISO-PET-06-1413
Identifier Type: OTHER
Identifier Source: secondary_id
TC-FMISO-PET-06-1413
Identifier Type: -
Identifier Source: org_study_id
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