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GNOSIS: Guidelines for Neuro-Oncology: Standards for Investigational Studies — reporting of surgically based therapeutic clinical trials

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Abstract

We present guidelines to standardize the reporting of surgically based neuro-oncology trials. The guidelines are summarized in a checklist format that can be used as a framework from which to construct a surgically based trial. This manuscript follows and is taken in part from GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies―reporting of phase 1 and phase 2 clinical trials [Chang SM, Reynolds SL, Butowski N, Lamborn KR, Buckner JC, Kaplan RS, Bigner DD (2005) Neuro-oncology 7:425–434].

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References

  1. Chang SM, Reynolds SL, Butowski N, Lamborn KR, Buckner JC, Kaplan RS, Bigner DD (2005) GNOSIS: guidelines for neuro-oncology: standards for investigational studies-reporting of phase 1 and phase 2 clinical trials. Neuro-oncology 7:425–434

    Article  PubMed  Google Scholar 

  2. Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ (2006) Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol 7:392–401

    Article  PubMed  CAS  Google Scholar 

  3. Laperriere NJ, Leung PM, McKenzie S, Milosevic M, Wong S, Glen J, Pintilie M, Bernstein M (1998) Randomized study of brachytherapy in the initial management of patients with malignant astrocytoma. Int J Radiat Oncol Biol Phys 41:1005–1011

    Article  PubMed  CAS  Google Scholar 

  4. Selker RG, Shapiro WR, Burger P, Blackwood MS, Arena VC, Gilder JC, Malkin MG, Mealey JJ Jr, Neal JH, Olson J, Robertson JT, Barnett GH, Bloomfield S, Albright R, Hochberg FH, Hiesiger E, Green S (2002) The Brain Tumor Cooperative Group NIH Trial 87-01: a randomized comparison of surgery, external radiotherapy, and carmustine versus surgery, interstitial radiotherapy boost, external radiation therapy, and carmustine. Neurosurgery 51:343–355; discussion 355–347

    Google Scholar 

  5. Gabayan AJ, Green SB, Sanan A, Jenrette J, Schultz C, Papagikos M, Tatter SP, Patel A, Amin P, Lustig R, Bastin KT, Watson G, Burri S, Stea B (2006) GliaSite brachytherapy for treatment of recurrent malignant gliomas: a retrospective multi-institutional analysis. Neurosurgery 58:701–709; discussion 701–709

    Google Scholar 

  6. Brem H, Piantadosi S, Burger PC, Walker M, Selker R, Vick NA, Black K, Sisti M, Brem S, Mohr G et al (1995) Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. The Polymer-brain Tumor Treatment Group. Lancet 345:1008–1012

    Article  PubMed  CAS  Google Scholar 

  7. Westphal M, Hilt DC, Bortey E, Delavault P, Olivares R, Warnke PC, Whittle IR, Jaaskelainen J, Ram Z (2003) A phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel wafers) in patients with primary malignant glioma. Neuro-oncology 5:79–88

    Article  PubMed  CAS  Google Scholar 

  8. Aghi M, Chiocca EA (2006) Gene therapy for glioblastoma. Neurosurg Focus 20:E18

    PubMed  Google Scholar 

  9. Chiocca EA (2003) Gene therapy: a primer for neurosurgeons. Neurosurgery 53:364–373; discussion 373

    Google Scholar 

  10. Chiocca EA, Broaddus WC, Gillies GT, Visted T, Lamfers ML (2004) Neurosurgical delivery of chemotherapeutics, targeted toxins, genetic and viral therapies in neuro-oncology. J Neurooncol 69:101–117

    Article  PubMed  Google Scholar 

  11. Lidar Z, Mardor Y, Jonas T, Pfeffer R, Faibel M, Nass D, Hadani M, Ram Z (2004) Convection-enhanced delivery of paclitaxel for the treatment of recurrent malignant glioma: a phase I/II clinical study. J Neurosurg 100:472–479

    Article  PubMed  CAS  Google Scholar 

  12. Sampson JH, Akabani G, Archer GE, Bigner DD, Berger MS, Friedman AH, Friedman HS, Herndon JE 2nd, Kunwar S, Marcus S, McLendon RE, Paolino A, Penne K, Provenzale J, Quinn J, Reardon DA, Rich J, Stenzel T, Tourt-Uhlig S, Wikstrand C, Wong T, Williams R, Yuan F, Zalutsky MR, Pastan I (2003) Progress report of a phase I study of the intracerebral microinfusion of a recombinant chimeric protein composed of transforming growth factor (TGF)-alpha and a mutated form of the Pseudomonas exotoxin termed PE-38 (TP-38) for the treatment of malignant brain tumors. J Neurooncol 65:27–35

    Article  PubMed  Google Scholar 

  13. Weber F, Asher A, Bucholz R, Berger M, Prados M, Chang S, Bruce J, Hall W, Rainov NG, Westphal M, Warnick RE, Rand RW, Floeth F, Rommel F, Pan H, Hingorani VN, Puri RK (2003) Safety, tolerability, and tumor response of IL4-Pseudomonas exotoxin (NBI-3001) in patients with recurrent malignant glioma. J Neurooncol 64:125–137

    Article  PubMed  Google Scholar 

  14. Hussain SF, Heimberger AB (2005) Immunotherapy for human glioma: innovative approaches and recent results. Expert Rev Anticancer Ther 5:777–790

    Article  PubMed  CAS  Google Scholar 

  15. Lang FF, Gilbert MR, Puduvalli VK, Weinberg J, Levin VA, Yung WK, Sawaya R, Fuller GN, Conrad CA (2002) Toward better early-phase brain tumor clinical trials: a reappraisal of current methods and proposals for future strategies. Neuro-oncology 4:268–277

    Article  PubMed  CAS  Google Scholar 

  16. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694

    PubMed  CAS  Google Scholar 

  17. Radner H, Blumcke I, Reifenberger G, Wiestler OD (2002) The new WHO classification of tumors of the nervous system 2000. Pathology and genetics. Pathologe 23:260–283

    Article  PubMed  CAS  Google Scholar 

  18. Scott CB, Nelson JS, Farnan NC, Curran WJ Jr, Murray KJ, Fischbach AJ, Gaspar LE, Nelson DF (1995) Central pathology review in clinical trials for patients with malignant glioma. A Report of Radiation Therapy Oncology Group 83-02. Cancer 76:307–313

    Article  PubMed  CAS  Google Scholar 

  19. NCI (2006) Common Technology Criteria for Adverse Events v.3.0 NCI Cancer Therapy Evaluation Program. Available at: http://ctep.cancer.gov/reporting/ctc.html. Accessed 5 October 2006

  20. NCI (2005) Adverse Event Expedited Reporting System (AdEERS). NCI Cancer Therapy Evaluation Program. Available at: http://ctep.cancer.gov/reporting/ctc.html. Accessed 5 October 2006

  21. Haines SJ (2002) Moving targets and ghosts of the past: outcome measurement in brain tumour therapy. J Clin Neurosci 9:109–112

    Article  PubMed  Google Scholar 

  22. Cairncross JG, Macdonald DR, Pexman JH, Ives FJ (1988) Steroid-induced CT changes in patients with recurrent malignant glioma. Neurology 38:724–726

    PubMed  CAS  Google Scholar 

  23. Macdonald DR, Cascino TL, Schold SC Jr, Cairncross JG (1990) Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 8:1277–1280

    PubMed  CAS  Google Scholar 

  24. Smith JS, Cha S, Mayo MC, McDermott MW, Parsa AT, Chang SM, Dillon WP, Berger MS (2005) Serial diffusion-weighted magnetic resonance imaging in cases of glioma: distinguishing tumor recurrence from postresection injury. J Neurosurg 103:428–438

    PubMed  Google Scholar 

  25. Parney IF, Kunwar S, McDermott M, Berger M, Prados M, Cha S, Croteau D, Puri RK, Chang SM (2005) Neuroradiographic changes following convection-enhanced delivery of the recombinant cytotoxin interleukin 13-PE38QQR for recurrent malignant glioma. J Neurosurg 102:267–275

    Article  PubMed  CAS  Google Scholar 

  26. Hess KR, Wong ET, Jaeckle KA, Kyritsis AP, Levin VA, Prados MD, Yung WK (1999) Response and progression in recurrent malignant glioma. Neuro-oncology 1:282–288

    Article  PubMed  CAS  Google Scholar 

  27. Lamborn KR, Chang SM, Prados MD (2004) Prognostic factors for survival of patients with glioblastoma: recursive partitioning analysis. Neuro-oncology 6:227–235

    Article  PubMed  Google Scholar 

  28. Wong ET, Hess KR, Gleason MJ, Jaeckle KA, Kyritsis AP, Prados MD, Levin VA, Yung WK (1999) Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J Clin Oncol 17:2572–2578

    PubMed  CAS  Google Scholar 

  29. Irish WD, Macdonald DR, Cairncross JG (1997) Measuring bias in uncontrolled brain tumor trials – to randomize or not to randomize? Can J Neurol Sci 24:307–312

    PubMed  CAS  Google Scholar 

  30. Kirby S, Brothers M, Irish W, Florell R, Macdonald D, Schold C, Cairncross G (1995) Evaluating glioma therapies: modeling treatments and predicting outcomes. J Natl Cancer Inst 87:1884–1888

    Article  PubMed  CAS  Google Scholar 

  31. Gaspar LE, Scott C, Murray K, Curran W (2000) Validation of the RTOG recursive partitioning analysis (RPA) classification for brain metastases. Int J Radiat Oncol Biol Phys 47:1001–1006

    Article  PubMed  CAS  Google Scholar 

  32. Scott CB, Scarantino C, Urtasun R, Movsas B, Jones CU, Simpson JR, Fischbach AJ, Curran WJ Jr (1998) Validation and predictive power of Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis classes for malignant glioma patients: a report using RTOG 90-06. Int J Radiat Oncol Biol Phys 40:51–55

    Article  PubMed  CAS  Google Scholar 

  33. Curran WJ Jr., Scott CB, Horton J, Nelson JS, Weinstein AS, Fischbach AJ, Chang CH, Rotman M, Asbell SO, Krisch RE et al (1993) Recursive partitioning analysis of prognostic factors in three Radiation Therapy Oncology Group malignant glioma trials. J Natl Cancer Inst 85:704–710

    Article  PubMed  Google Scholar 

  34. Gaspar L, Scott C, Rotman M, Asbell S, Phillips T, Wasserman T, McKenna WG, Byhardt R (1997) Recursive partitioning analysis (RPA) of prognostic factors in three Radiation Therapy Oncology Group (RTOG) brain metastases trials. Int J Radiat Oncol Biol Phys 37:745–751

    Article  PubMed  CAS  Google Scholar 

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Acknowledgments

We thank Ilona Garner, Department of Neurological Surgery, University of California, San Francisco, for editorial support.

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Authors and Affiliations

  1. Neuro-oncology Service, Department of Neurological Surgery, University of California San Francisco, 400 Parnassus Avenue, A-808, San Francisco, CA, 94143-0350, USA

    Susan Chang, Sandeep Kunwar & Andrew Parsa

  2. Department of Neurological Surgery, Brain Tumor Institute, Cleveland Clinic, Cleveland, OH, 44195, USA

    Michael Vogelbaum

  3. Department of Neurosurgery, University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA

    Frederick F. Lang

  4. Department of Neurosurgery, University of Minnesota, Minneapolis, MN, 55455, USA

    Stephen Haines

  5. Department of Neurosurgery, Ohio State University Medical Center, Columbus, OH, 43210, USA

    E. Antonio Chiocca

  6. Department of Neurosurgery, Johns Hopkins University, Baltimore, MD, 21287, USA

    Alessandro Olivi & Alfredo Quinones-Hinojosa

  7. Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, 45267, USA

    Ronald Warnick

Authors
  1. Susan Chang
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  2. Michael Vogelbaum
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  3. Frederick F. Lang
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  4. Stephen Haines
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  5. Sandeep Kunwar
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  7. Alessandro Olivi
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Corresponding author

Correspondence to Susan Chang.

Additional information

For the American Association of Neurological Surgeons and Congress of Neurological Surgeons (AANS/CNS) Section on Tumors.

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Chang, S., Vogelbaum, M., Lang, F.F. et al. GNOSIS: Guidelines for Neuro-Oncology: Standards for Investigational Studies — reporting of surgically based therapeutic clinical trials . J Neurooncol 82, 211–220 (2007). https://doi.org/10.1007/s11060-006-9271-5

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  • DOI: https://doi.org/10.1007/s11060-006-9271-5

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