Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov

Radiation Oncology

Volumn 12, Issue 1, 2017, Pages

  Cihoric, Nikola ^a   Tsikkinis, Alexandros ^b   Minniti, Giuseppe ^c   Lagerwaard, Frank J ^d   Herrlinger, Ulrich ^e   Mathier, Etienne ^a   Soldatovic, Ivan ^f   Jeremic, Branislav ^g   Ghadjar, Pirus ^h   Elicin, Olgun ^a   Lössl, Kristina ^a   Aebersold, Daniel M ^a   Belka, Claus ^i,j   Herrmann, Evelyn ^a   Niyazi, Maximilian ^i,j  

^a UNIVERSITY OF BERN   (Switzerland)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c IRCCS NEUROMED   (Italy)

^d VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY HOSPITAL BONN   (Germany)

^f UNIVERSITY OF BELGRADE   (Serbia)

^g Institute of Lung Diseases   (Serbia)

^h CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

ⁱ UNIVERSITY OF MUNICH   (Germany)

^j GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

more..

Author keywords

Clinicaltrials.gov; Glioblastoma; Interventional Clinical Trials

Indexed keywords

CANCER CLASSIFICATION; CANCER RADIOTHERAPY; CANCER SURGERY; CENTRAL NERVOUS SYSTEM; CHEMORADIOTHERAPY; DIAGNOSTIC IMAGING; FINANCIAL MANAGEMENT; GLIOBLASTOMA; HUMAN; ONCOLOGIST; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RECURRENT DISEASE; REVIEW; SURGICAL TECHNIQUE; CLINICAL TRIAL (TOPIC); METHODOLOGY; PROCEDURES;

CLINICAL TRIALS AS TOPIC; GLIOBLASTOMA; HUMANS; RESEARCH DESIGN;

EID: 85008238652     PISSN: None     EISSN: 1748717X     Source Type: Journal    
DOI: 10.1186/s13014-016-0740-5     Document Type: Review

References (63)

1. Buckner JC. Factors influencing survival in high-grade gliomas. Semin Oncol. 2003;30(6 Suppl 19):10-4.
2. Curran Jr WJ, Scott CB, Horton J, Nelson JS, Weinstein AS, Fischbach AJ, Chang CH, Rotman M, Asbell SO, Krisch RE, et al. Recursive partitioning analysis of prognostic factors in three Radiation Therapy Oncology Group malignant glioma trials. J Natl Cancer Inst. 1993;85(9):704-10.
3. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-96.
4. Burdett S, Pignon JP, Tierney J, Tribodet H, Stewart L, Le Pechoux C, Auperin A, Le Chevalier T, Stephens RJ, Arriagada R, et al. Adjuvant chemotherapy for resected early-stage non-small cell lung cancer. Cochrane Database Syst Rev. 2015;3:CD011430.
5. Wollmann G, Ozduman K, van den Pol AN. Oncolytic virus therapy for glioblastoma multiforme: concepts and candidates. Cancer J. 2012;18(1):69-81.
6. Olson JJ, Nayak L, Ormond DR, Wen PY, Kalkanis SN, Committee ACJG. The role of cytotoxic chemotherapy in the management of progressive glioblastoma: a systematic review and evidence-based clinical practice guideline. J Neuro-Oncol. 2014;118(3):501-55.
7. Cabrera AR, Kirkpatrick JP, Fiveash JB, Shih HA, Koay EJ, Lutz S, Petit J, Chao ST, Brown PD, Vogelbaum M, et al. Radiation therapy for glioblastoma: Executive summary of an American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline. Pract Radiat Oncol. 2016;6(4):217-25.
8. Niyazi M, Brada M, Chalmers AJ, Combs SE, Erridge SC, Fiorentino A, Grosu AL, Lagerwaard FJ, Minniti G, Mirimanoff RO, et al. ESTRO-ACROP guideline "target delineation of glioblastomas". Radiother Oncol. 2016;118(1):35-42.
9. WHO: WHO Trial Search Portal. In.
10. WMA. In: WMA Declaration of Helsinki. http://www.wma.net/en/30publications/10policies/b3/. Accessed 2 Nov 2016.
11. ICMJE: Clinical Trial Registration Statement. In.
12. Becker JE, Ross JS. Reporting discrepancies between the clinicaltrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;161(10):760.
13. Cihoric N, Tsikkinis A, van Rhoon G, Crezee H, Aebersold DM, Bodis S, Beck M, Nadobny J, Budach V, Wust P et al.: Hyperthermia-related clinical trials on cancer treatment within the ClinicalTrials.gov registry. Int J Hyperthermia 2015;31:1-6.
14. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov 2007-2010. JAMA. 2012;307(17):1838-47.
15. Tsikkinis A, Cihoric N, Giannarini G, Hinz S, Briganti A, Wust P, Ost P, Ploussard G, Massard C, Surcel CI et al.: Clinical perspectives from Randomized Phase 3 trials on Prostate Cancer: An Analysis of the Clinicaltrials.gov Database. European Urology Focus 2015.
16. Cihoric N, Tsikkinis A, Miguelez CG, Strnad V, Soldatovic I, Ghadjar P, Jeremic B, Dal Pra A, Aebersold DM, Lossl K. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database. Radiat Oncol. 2016;11(1):48. doi: 10.1186/s13014-016-0624-8.
17. Gillen JE, Tse T, Ide NC, McCray AT. Design, implementation and management of a web-based data entry system for ClinicalTrials.gov. Stud Health Technol Inform. 2004;107(Pt 2):1466-70.
18. Tse T, Williams RJ, Zarin DA. Update on Registration of Clinical Trials in ClinicalTrials.gov. Chest. 2009;136(1):304-5.
19. Clarke JL, Molinaro AM, Phillips JJ, Butowski NA, Chang SM, Perry A, Costello JF, DeSilva AA, Rabbitt JE, Prados MD. A single-institution phase II trial of radiation, temozolomide, erlotinib, and bevacizumab for initial treatment of glioblastoma. Neuro Oncol. 2014;16(7):984-90.
20. Wishart DS, Knox C, Guo AC, Shrivastava S, Hassanali M, Stothard P, Chang Z, Woolsey J. DrugBank: a comprehensive resource for in silico drug discovery and exploration. Nucleic Acids Res. 2006;34(Database issue):D668-672.
21. Hjalgrim LL, Rostgaard K, Engholm G, Pukkala E, Johannesen TB, Olafsdottir E, Hjalgrim H. Aetiologic heterogeneity in pediatric Hodgkin lymphoma? Evidence from the Nordic countries, 1978-2010. Acta Oncol. 2016;55(1):85-90.
22. WHO Collaborating Centre for Drug Statistics Methodology O, Norway. WHO Collaborating Centre for Drug Statistics Methodology, Guidelines for ATC classification and DDD assignment 2015. 19th ed. Oslo: World Health Organization Oslo; 2015.
23. Brockwell PJ, Davis RA: Introduction to time series and forecasting: Springer Science & Business Media; 2006
24. Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Oncol. 2015;33(9):975-7.
25. Hirsch BR, Califf RM, Cheng SK, Tasneem A, Horton J, Chiswell K, Schulman KA, Dilts DM, Abernethy AP. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med. 2013;173(11):972-9.
26. Duffau H. Long-term outcomes after supratotal resection of diffuse low-grade gliomas: a consecutive series with 11-year follow-up. Acta Neurochir (Wien). 2016;158(1):51-8.
27. Lacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, et al. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001;95(2):190-8.
28. Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011;115(1):3-8.
29. Marko NF, Weil RJ, Schroeder JL, Lang FF, Suki D, Sawaya RE. Extent of resection of glioblastoma revisited: personalized survival modeling facilitates more accurate survival prediction and supports a maximum-safe-resection approach to surgery. J Clin Oncol. 2014;32(8):774-82.
30. Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, et al. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007;356(15):1527-35.
31. Scott JG, Bauchet L, Fraum TJ, Nayak L, Cooper AR, Chao ST, Suh JH, Vogelbaum MA, Peereboom DM, Zouaoui S, et al. Recursive partitioning analysis of prognostic factors for glioblastoma patients aged 70 years or older. Cancer. 2012;118(22):5595-600.
32. Vuorinen V, Hinkka S, Farkkila M, Jaaskelainen J. Debulking or biopsy of malignant glioma in elderly people - a randomised study. Acta Neurochir (Wien). 2003;145(1):5-10.
33. Almenawer SA, Badhiwala JH, Alhazzani W, Greenspoon J, Farrokhyar F, Yarascavitch B, Algird A, Kachur E, Cenic A, Sharieff W, et al. Biopsy versus partial versus gross total resection in older patients with high-grade glioma: a systematic review and meta-analysis. Neuro Oncol. 2015;17(6):868-81.
34. Minniti G, De Sanctis V, Muni R, Filippone F, Bozzao A, Valeriani M, Osti MF, De Paula U, Lanzetta G, Tombolini V, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma in elderly patients. J Neurooncol. 2008;88(1):97-103.
35. Brandes AA, Franceschi E, Tosoni A, Benevento F, Scopece L, Mazzocchi V, Bacci A, Agati R, Calbucci F, Ermani M. Temozolomide concomitant and adjuvant to radiotherapy in elderly patients with glioblastoma: correlation with MGMT promoter methylation status. Cancer. 2009;115(15):3512-8.
36. Roa W, Brasher PM, Bauman G, Anthes M, Bruera E, Chan A, Fisher B, Fulton D, Gulavita S, Hao C, et al. Abbreviated course of radiation therapy in older patients with glioblastoma multiforme: a prospective randomized clinical trial. J Clin Oncol. 2004;22(9):1583-8.
37. Malmstrom A, Gronberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, et al. Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012;13(9):916-26.
38. Fiorentino A, Balducci M, De Bonis P, Chiesa S, De Filippo L, Mangiola A, De Rose F, Autorino R, Rinaldi C, Fersino S, et al. Can elderly patients with newly diagnosed glioblastoma be enrolled in radiochemotherapy trials? Am J Clin Oncol. 2015;38(1):23-7.
39. Minniti G, Lanzetta G, Scaringi C, Caporello P, Salvati M, Arcella A, De Sanctis V, Giangaspero F, Enrici RM. Phase II study of short-course radiotherapy plus concomitant and adjuvant temozolomide in elderly patients with glioblastoma. Int J Radiat Oncol Biol Phys. 2012;83(1):93-9.
40. Azoulay M, Santos F, Souhami L, Panet-Raymond V, Petrecca K, Owen S, Guiot MC, Patyka M, Sabri S, Shenouda G, et al. Comparison of radiation regimens in the treatment of Glioblastoma multiforme: results from a single institution. Radiat Oncol. 2015;10:106.
41. Badiyan SN, Markovina S, Simpson JR, Robinson CG, DeWees T, Tran DD, Linette G, Jalalizadeh R, Dacey R, Rich KM, et al. Radiation therapy dose escalation for glioblastoma multiforme in the era of temozolomide. Int J Radiat Oncol Biol Phys. 2014;90(4):877-85.
42. Halperin EC, Bentel G, Heinz ER, Burger PC. Radiation therapy treatment planning in supratentorial glioblastoma multiforme: an analysis based on post mortem topographic anatomy with CT correlations. Int J Radiat Oncol Biol Phys. 1989;17(6):1347-50.
43. Tsien CI, Brown D, Normolle D, Schipper M, Piert M, Junck L, Heth J, Gomez-Hassan D, Ten Haken RK, Chenevert T, et al. Concurrent temozolomide and dose-escalated intensity-modulated radiation therapy in newly diagnosed glioblastoma. Clin Cancer Res. 2012;18(1):273-9.
44. Bodensohn R, Sohn M, Ganswindt U, Schupp G, Nachbichler SB, Schnell O, Belka C, Niyazi M. Hippocampal EUD in primarily irradiated glioblastoma patients. Radiat Oncol. 2014;9:276.
45. Adeberg S, Bostel T, Konig L, Welzel T, Debus J, Combs SE. A comparison of long-term survivors and short-term survivors with glioblastoma, subventricular zone involvement: a predictive factor for survival? Radiat Oncol. 2014;9:95.
46. Wick W, Fricke H, Junge K, Kobyakov G, Martens T, Heese O, Wiestler B, Schliesser MG, von Deimling A, Pichler J, et al. A phase II, randomized, study of weekly APG101 + reirradiation versus reirradiation in progressive glioblastoma. Clin Cancer Res. 2014;20(24):6304-13.
47. Kuger S, Flentje M, Djuzenova CS. Simultaneous perturbation of the MAPK and the PI3K/mTOR pathways does not lead to increased radiosensitization. Radiat Oncol. 2015;10:214.
48. Qian LW, Mizumoto K, Urashima T, Nagai E, Maehara N, Sato N, Nakajima M, Tanaka M. Radiation-induced increase in invasive potential of human pancreatic cancer cells and its blockade by a matrix metalloproteinase inhibitor, CGS27023. Clinical Cancer Res. 2002;8(4):1223-7.
49. Camphausen K, Moses MA, Beecken WD, Khan MK, Folkman J, O'Reilly MS. Radiation therapy to a primary tumor accelerates metastatic growth in mice. Cancer Res. 2001;61(5):2207-11.
50. Cordes N, Hansmeier B, Beinke C, Meineke V, van Beuningen D. Irradiation differentially affects substratum-dependent survival, adhesion, and invasion of glioblastoma cell lines. Br J Cancer. 2003;89(11):2122-32.
51. Wild-Bode C, Weller M, Rimner A, Dichgans J, Wick W. Sublethal irradiation promotes migration and invasiveness of glioma cells: implications for radiotherapy of human glioblastoma. Cancer Res. 2001;61(6):2744-50.
52. Gebhardt BJ, Dobelbower MC, Ennis WH, Bag AK, Markert JM, Fiveash JB. Patterns of failure for glioblastoma multiforme following limited-margin radiation and concurrent temozolomide. Radiat Oncol. 2014;9:130.
53. Ali AN, Ogunleye T, Hardy CW, Shu HK, Curran WJ, Crocker IR. Improved hippocampal dose with reduced margin radiotherapy for glioblastoma multiforme. Radiat Oncol. 2014;9:20.
54. Miwa K, Matsuo M, Ogawa S, Shinoda J, Yokoyama K, Yamada J, Yano H, Iwama T. Re-irradiation of recurrent glioblastoma multiforme using 11C-methionine PET/CT/MRI image fusion for hypofractionated stereotactic radiotherapy by intensity modulated radiation therapy. Radiat Oncol. 2014;9:181.
55. Jonsson JH, Akhtari MM, Karlsson MG, Johansson A, Asklund T, Nyholm T. Accuracy of inverse treatment planning on substitute CT images derived from MR data for brain lesions. Radiat Oncol. 2015;10:13.
56. Lu-Emerson C, Duda DG, Emblem KE, Taylor JW, Gerstner ER, Loeffler JS, Batchelor TT, Jain RK. Lessons from anti-vascular endothelial growth factor and anti-vascular endothelial growth factor receptor trials in patients with glioblastoma. J Clin Oncol. 2015;33(10):1197-213.
57. Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010;28(11):1963-72.
58. Raftery J, Young A, Stanton L, Milne R, Cook A, Turner D, Davidson P. Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme. Health Technol Assess. 2015;19(11):1-138.
59. Rubner Y, Muth C, Strnad A, Derer A, Sieber R, Buslei R, Frey B, Fietkau R, Gaipl US. Fractionated radiotherapy is the main stimulus for the induction of cell death and of Hsp70 release of p53 mutated glioblastoma cell lines. Radiat Oncol. 2014;9(1):89.
60. Galanis E, Wu W, Cloughesy T, Lamborn K, Mann B, Wen PY, Reardon DA, Wick W, Macdonald D, Armstrong TS, et al. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012;13(5):e196-204.
61. Huser V, Cimino JJ. Precision and negative predictive value of links between ClinicalTrials.gov and PubMed. AMIA Annu Symp Proc. 2012;2012:400-8.
62. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292.
63. Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013;347:f6104.