Appendix Table C73. Design, participant selection and enrollment: Glial tumors

Study (Investiga-tor, country, year) / Re-cord Number / Indication / Dis-ease / Therapeutic Setting / Group (N) / Partici-pant Selection (Treat-ment Period) / Design / n, Evaluated / n, Withdrawn (Lost to F/U) / Comment
Ayan, Turkey, 1995 / 74690 / Malignant Non-hematopoietic / Glial / Newly diagnosed, high-risk / Anaplastic ependymoma 4 / January 1990 - May 1991 / Case series / 4 / 1 patient lost to follow up at 9 months, had no response to treatment
Berger, France, 1998 / 75380 / Malignant non-hematopoietic / glial / Newly Diagnosed / HSCT Choroid plexus tumor (2) Conventional Therapy Choroid plexus tumor (20) / 1984-1995 / Case series / 22 / 0
Bertolone, United States, 2003 / 10380 / Malignant Non-Hematopoietic / Glial / Patients with no previous CHM or RT who had been histopathologically confirmed to have a high-grade astrocytoma after surgical resection / 18 / April 1985 - May 1990 / Randomized trial with non randomized infant component / 18 / 0 / 4 patients were excluded due to consensus pathology diagnosis, 1 juvenile pilocytic astrocytoma 2 low-grade astrocytoma and 1 medulloblastoma
Bouffet, France, 1997 / 78760 / Malignant Non-Hematopoietic / Glial / Recurrent / 5 / NR / Case Series / 5 / 0 / 13 children with high grade glioma were enrolled in this study. 8 were newly diagnosed and exclude while 5 were recurrent after induction chemotherapy
Bouffet, France, 2000 / 78770 / Malignant Non-hematopoietic / Glial / Newly diagnosed pontine glioma / 36 / March 1990-? / Case series / 24 / 12
Busca, Italy, 1997 / 73190 / Malignant Non-hematopoietic / Glial / Malignant recurrent or progressive CNS tumor / Ependymoma 2, Anaplastic Astrocytoma 1, Glioblastoma Multiforme 2, Oligodendroglioma 1 / May 1991 - August 1996 / Case series / 6 / 0 / Preliminary results of the present study indicate that children with both recurrent and newly diagnosed brain tumors may benefit from high-dose chemotherapy
Conter, France, 2009 / 73540 / Malignant Non-hematopoietic / Glial / Varied / Ependymoma 24 / November 1996 - December 2002 / Retrospective case series / 24 / 0
Doireau, France, 1998 / 55990 / Malignant Non-Hematopoietic / Glial / Recurrent or unresectable tumors / 8 / May 1992 - January 1998 / Case series / 8 / 1 dead of disease
Dunkel, United States, 1998 / 78780 / Malignant Non-Hematopoietic / Glial / Recurrent / 10 / NR / Case Series / 10 / 0 / 16 patients were enrolled in this study, 6 were excluded based on newly diagnosed pontine tumors with no previous therapy
Finlay, United States / 1300 / Malignant Non-Hematopoietic / Glial / Recurrent Malignant Astrocytoma / 27 / NR / Quasi-Experimental Study w/ prospective cohort compared to CCG-945 controls / 27, 56 control / 0
Grill, France, 1996 / 73240 / Malignant Non-Hematopoietic / Glial / Recurrent / Ependymoma 16 / 1988 - 1994 / Case Series / 16 / 0 / authors suggest the high-dose busulfan-thiotepa combination had little if any activity in refractory or relapsed ependymoma of children. New therapeutic approaches must be evaluated
Grill, France, 2001 / 74360 / Malignant non-hematopoietic / Glial / Newly Diagnosed, high grade ependymoma / 73 / June 1990 - December 1998 / Case Series / 73 / 0
Grovas, United States, 1999 / 16600 / Malignant Non-hematopoietic / Glial / Newly Diagnosed High-Risk / 11 / 1993-1995 / Case series / 11 / 0
Grundy, United Kingdom, 2007 / 73750 / Malignant non-hematopoietic / Glial / Newly Diagnosed, 9 pts metastatic / Ependymoma 89 / 1992 - 2003 / case-series / 89 / 0
Grundy, United States, 2010 / 51800 / Malignant Non-Hematopoietic / Glial / No prior adjuvant drug or radiotherapy / 45 / March 1993 - July 2003 / Case series / 41 / 4
Gururangan, United States, 1998 / 18000 / Malignant non-hematopoietic / Glial / recurrent / N=7, 1 ependymoma, 4 glioblastoma multiforme, 1 anaplastic astrocytoma, 1 CPC / 1989-1996 / Cohort / n=7 / 0
Horn, Untied States, 1999 / 74470 / Malignant non-hematopoietic / Glial / Varied / Ependymoma 83 / 1987-1991 / Retrospective case series / 83 / 0 / 11 center retrospective
Hurwitz, United States, 2001 / 53330 / Malignant Non-Hematopoietic / Glial / Recurrent or Progressive brain tumors / 45 / June 1993 - March 1998 / Case Series / 45 / 0 / 75 enrolled 45 eligible based on histology
Jaing, Taiwan, 2004 / 74030 / Malignant Non-hematopoietic / Glial / Newly diagnosed high and low grade ependymomas / Ependymoma 46 / 43 / 3 excluded due to one death in immediate postoperative period and 2 spinal cord tumors. 2 patients were also lost to follow up
Jakacki, United States, 1999 / 15920 / Malignant non-hematopoietic / glial / High-dose chemotherapy / 11 / April 1997 - June 1998 / Case series / 11 / 0 / Study enrollment stopped early due to concerns about radio-potentiating effects of chemotherapy given concurrently with radiation 1 pt excluded due to age above 21 years
Kobrinsky, United States, 1999 / 53560 / Malignant Non-Hematopoietic / Glial / Recurrent or unresponsive / 42 / December 1988 - February 1992 / Case Series / 42 / 0 / 99 patients enrolled, 42 eligible based on histology glioma
Korones, United States, 2006 / 52670 / Malignant Non-Hematopoietic / Glial / Recurrent / 9 / June 2002 - October 2003 / Retrospective case series / 9 / 0 / 2 patients excluded due to being above age 21
Kuhl, Germany, 1998 / 17700 / Malignant Non-hematopoietic / Glial / Untreated, newly diagnosed ependymoma / 21 / 1987 - 1991 / Phase II trial / 10 / 11
Macdonald, United States, 2005 / 55000 / Malignant Non-Hematopoietic / Glial / Newly Diagnosed High-Grade / 102 / 1993-1998 / Randomized Trial / 76 / 11 pts did not complete HDCT due to toxicities / 26 patients excluded after central neuroradiographic review or pathological review
Mahoney, United States, 1996 / 73250 / Malignant Non-hematopoietic / Glial / Recurrent or Progressive / 7 / December 1990 - September 1993 / case series / 7 / 0 / 7 of 19 patients included based on tumor diagnosis
Mason, United States, 1998 / 73180 / Malignant Non-hematopoietic / Glial / Recurrent / Ependymoma 15 / December 1986 - November 1993 / PII trial / 15 / 0 / Given the dismal performance of this regimenin controlling recurrent intracranial ependymoma in children we cannot recommend this approach of invasive chemotherapy with this regimen as an effective strategy for recurrent disease.
Massimino, Italy, 2005 / 55220 / Malignant Non-Hematopoietic / Glial / Consolidate high-risk / 21 / August 1996-March 2003 / Case series / 21 / 0 / *Was in comparator search
Merchant, United States, 2002 / 74280 / Malignant non-hematopoietic / Glial / Varied / Ependymoma 64 / June 1997 - / PII trial / 64 / 0
Ozkaynak, United States, 2004 / 7850 / Malignant Non-Hematopoietic / Glial / Relapsed/Progressive : Tandem Treatment / 6 / 1995-2002 / Case Series / 6 / 0 / Tandem Treatment, not on initial indications for abstraction
Robertson, United States, 1998 / 74630 / Malignant non-hematopoietic / Glial / High-risk / ependymoma 20, anaplastic ependymoma 12 / May 1986 - June 1992 / RCT / 32 / 0 / High degree of discordance between local institutional diagnoses and centralized review (31% concordance)
Shih, United States, 2008 / 2530 / Malignant Non-Hematopoietic / Glial / Recurrent / 5 / 1989-2004 / Retrospective case series / 5 / 0 / Of 27 initial patients 5 met inclusion criteria for this abstraction (19)
Sio, Italy, 2006 / 6950 / Malignant Non-Hematopoietic / Glial / Relapsed / 14 / April 1998 - April 2004 / Case series (off-label compassionate use) / 14 / 52 total patients, 38 excluded based on histology or age > 21
Thorarinsdottir, United States, 2007 / 73050 / Malignant Non-hematopoietic / Glial / Malignant CNS / 6 / 1998 - 2005 / Case series / 6 / 0 / 6 of 15 patients included based on tumor type
Wrede, Germany, 2009 / 75590 / Malignant Non-hematopoietic / Glial / Newly Diagnosed / 34 CPC / 2000-2008 / Case series / 29 CPC / 5
Yule, United Kingdom, 1997 / 18960 / Malignant Non-hematopoietic / Glial / High-Risk and Recurrent Tandem (?) / 5 / 1993-1995 / Case Series / 5 / 0 / 8 patients excluded based on tumor histology
Zacharoulis, United States, 2007 / 73020 / Malignant Non-hematopoietic / Glial / No previous treatment, confirmed ependymoma / 29 / 1991-1997 (Head Start 1), 1997 - 2002 (Head Start 2) / Cohort study / 29 / 0
Gilheeney, United States, 2010 / 2187 / Malignant Solid Tumor / High Grade Glioma / Metastatic or Recurrent Glioma / Anaplastic Astrocytoma (1); Oligoastrocytoma (1); Glioblastoma multiforme (2) / 1999-2002 / Case Series / 4 / 0