Medulloblastoma

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 Nikki M. Wood, DO
University of Missouri
Kansas City, MO
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Guidelines

EANO/EURACAN

Upfront Therapy Older Children

COG ACNS0331 Standard Dose CSRT with Reduced Volume Boost to Tumor Bed

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Michalski et al. 2021 (COG ACNS0331) 2004-04-30 to 2014-01-06 Phase 3 (E-de-esc) COG ACNS0331 Protocol for Standard Dose CSRT with Standard Volume Boost Non-inferior EFS (primary endpoint)
EFS60: 82.5% vs 80.5%
(HR 0.97, 94% CI 1.32)

Note: this protocol is given in two parts, induction (chemoradiation) followed by maintenance. The induction portion lasts 6 weeks, followed by 4 weeks of rest (weeks 7-10), followed by the maintenance portion which lasts for 58 weeks, consisting of alternating A cycles and B cycles (AAB-AAB-AAB). The non-inferiority comparison was one-sided, with the upper bound reported here.

  • Ages 3+
  • All patients must begin therapy within 31 days of surgery.

Induction

Radiotherapy

Chemotherapy

  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
    • Round vincristine down to the nearest 0.1 mg

6-week course, followed by 4-weeks rest, followed by:


Maintenance

Chemotherapy, part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)

  • Cisplatin (Platinol) 75 mg/m2 IV once on day 1
  • Lomustine (CCNU) 75 mg/m2 PO once on day 1 on an empty stomach (at least 2 hours after food) preferably at bedtime (reduce N/V)
  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1, 8, 15
      • Dose rounded down to the nearest 0.1 mg
      • Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Chemotherapy, part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

  • Cyclophosphamide (Cytoxan) 1000 mg/m2 IV over 60 minutes once per day on days 1 & 2
  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1, 8
      • Dose rounded down to the nearest 0.1 mg
      • Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Supportive therapy, part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

  • Mesna (Mesnex) 360 mg/m2 IV over 15 to 30 minutes once per day on days 1 & 2
      • Dose is given at least 15 minutes prior to or at the same time as cyclophosphamide and repeated at 4 and 8 hours post cyclophosphamide
      • Can be given via continuous infusion starting 15 to 30 minutes before or at the same time as cyclophosphamide and finished no sooner than 8 hours after the end of the cyclophosphamide infusion

Maintenance is 9 cycles; this is given in an AAB-AAB-AAB sequence, where cycle A is 42 days/6 weeks and cycle B is 28 days/4 weeks

References

  1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. Epub 2021 Jun 10. link to original article link to PMC article PubMed Clinical Trial Registry

COG ACNS0331 Standard Dose CSRT with Standard Volume Boost

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Michalski et al. 2021 (COG ACNS0331) 2004-04-30 to 2014-01-06 Phase 3 (C) COG ACNS0331 Protocol for Standard Dose CSRT with Reduced Volume Boost to Tumor Bed Non-inferior EFS
  • Ages 3+
  • All patients must begin therapy within 31 days of surgery.

Induction

Radiotherapy

Chemotherapy

  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 8, 15, 22, 29, 36, 43 (Once a week starting one week after CSRT begins)
    • Round vincristine down to the nearest 0.1 mg

6-week course, followed by 4-weeks rest, followed by:


Maintenance

Chemotherapy, part A (Cycles 1, 2, 4, 5, 7, 8)(6 weeks=1 cycle)

  • Cisplatin (Platinol) 75 mg/m2 IV once on day 1
  • Lomustine (CCNU) 75 mg/m2 PO once on day 1 on an empty stomach (at least 2 hours after food) preferably at bedtime (reduce N/V)
  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1, 8, 15
    • Dose rounded down to the nearest 0.1 mg
    • Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Chemotherapy, part B (Cycles 3, 6, 9)(4 weeks=1cycle)

  • Cyclophosphamide (Cytoxan) 1000 mg/m2 IV over 60 minutes once per day on days 1 & 2
  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1, 8
    • Dose rounded down to the nearest 0.1 mg
    • Can be given IV push over 1-minute or by infusion via minibag as per institution policy

Supportive therapy, part B (Cycles 3, 6, 9)(4 weeks=1 cycle)

  • Mesna (Mesnex) 360 mg/m2 IV over 15 to 30 minutes once per day on days 1 & 2
    • Dose given at least 15 minutes prior to or at the same time as cyclophosphamide and repeated at 4 and 8 hours after cyclophosphamide
    • Can be given via continuous infusion starting 15 to 30 minutes before or at the same time as cyclophosphamide and finished no sooner than 8 hours after the end of the cyclophosphamide infusion

Maintenance is 9 cycles; this is given in an AAB-AAB-AAB sequence, where cycle A is 42 days/6 weeks and cycle B is 28 days/4 weeks

References

  1. COG ACNS0331: Michalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. Epub 2021 Jun 10. link to original article link to PMC article PubMed Clinical Trial Registry

COG ACNS0332 Protocol A

Protocol

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Leary et al. 2021 (COG ACNS0332) 2007-03 to 2018-09 Phase 3 (C) COG ACNS0332 Protocol B (with carboplatin) Did not meet primary endpoint of EFS

Radiotherapy, induction

  • Craniospinal External beam radiotherapy 36 Gy in 20 daily fractions (Monday - Friday)
  • Posterior Fossa Boost External beam radiotherapy 19.8 Gy in 11 daily fractions (Cumulative dose of 55.8 Gy)
    • For additional boost details, such as technique and location, please see the full protocol as this depends on the site of metastases and disease stage

Chemotherapy, induction

  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15, 22, 29, 36 (Once a week starting within one week of the start of CSRT)
    • Round vincristine down to the nearest 0.1 mg

6-week course, followed by:

Chemotherapy, maintenance

  • Cisplatin (Platinol) 75 mg/m2 IV over 60 minutes once on day 1
  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8
    • Round vincristine down to the nearest 0.1 mg
  • Cyclophosphamide (Cytoxan) 1000 mg/m2 IV over 60 minutes once per day on days 2 & 3, given at least 24 hours after cisplatin on day 2

28-day cycle for 6 cycles; begin each cycle on day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours

References

  1. COG ACNS0332: Leary SES, Packer RJ, Li Y, Billups CA, Smith KS, Jaju A, Heier L, Burger P, Walsh K, Han Y, Embry L, Hadley J, Kumar R, Michalski J, Hwang E, Gajjar A, Pollack IF, Fouladi M, Northcott PA, Olson JM. Efficacy of Carboplatin and Isotretinoin in Children With High-risk Medulloblastoma: A Randomized Clinical Trial From the Children's Oncology Group. JAMA Oncol. 2021 Sep 1;7(9):1313-1321. link to original article link to PMC article PubMed Clinical Trial Registry

COG ACNS0332 Protocol B

Protocol

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Leary et al. 2021 (COG ACNS0332) 2007-03 to 2018-09 Phase 3 (E-esc) COG ACNS0332 Protocol A (no carboplatin) Did not meet primary endpoint of EFS

Radiotherapy, induction

For additional boost details, such as technique and location, please see the full protocol as this depends on the site of metastases and disease stage

Chemotherapy, induction

  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15, 22, 29, 36 (Once a week starting within one week of the start of CSRT)
    • Round vincristine down to the nearest 0.1 mg
    • Administer prior to Carboplatin
  • Carboplatin (Paraplatin) 35 mg/m2 IV over 15 minutes once per day, given 1 to 4 hours prior to radiation therapy (Total of 30 doses)
    • First dose administered on the first day of radiation therapy
    • Should be HELD if radiation treatment is not given
    • Since there are 31 fractions of radiation, No carboplatin should be given prior to the final radiation fraction

6-week course, followed by:

Chemotherapy, maintenance

  • Cisplatin (Platinol) 75 mg/m2 IV over 60 minutes once on day 1
  • Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1 & 8
    • Round vincristine down to the nearest 0.1 mg
  • Cyclophosphamide (Cytoxan) 1000 mg/m2 IV over 60 minutes once per day on days 2 & 3, given at least 24 hours after cisplatin on day 2

28-day cycle for 6 cycles; begin each cycle on day 29 and when ANC ≥ 750/μL, platelets ≥ 75,000/μL, and the patient has been off of myeloid growth factor for at least 24 hours

References

  1. COG ACNS0332: Leary SES, Packer RJ, Li Y, Billups CA, Smith KS, Jaju A, Heier L, Burger P, Walsh K, Han Y, Embry L, Hadley J, Kumar R, Michalski J, Hwang E, Gajjar A, Pollack IF, Fouladi M, Northcott PA, Olson JM. Efficacy of Carboplatin and Isotretinoin in Children With High-risk Medulloblastoma: A Randomized Clinical Trial From the Children's Oncology Group. JAMA Oncol. 2021 Sep 1;7(9):1313-1321. link to original article link to PMC article PubMed Clinical Trial Registry

Upfront Therapy, Younger Children

COG ACNS0334 Protocol A

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (COG ACNS0334) 2007-NR Phase 3 (C) COG ACNS0334 Protocol B (HD-MTX) TBD

Induction

Chemotherapy

Supportive therapy

  • Mesna (Mesnex) 12 mg/kg IV five times per day on days 1 & 2
    • Dose 1: Initial bolus dose of may be administered before or at the same time as the cyclophosphamide
    • Dose 2: A 3-hour infusion immediately after the cyclophosphamide infusion (Hours 2 - 5)
    • Doses 3 to 5: 3 subsequent bolus doses are given at hours 6, 9, 12, or by institutional protocol
    • Mesna (Mesnex) may also be given as a 24-hour continuous infusion starting 30 minutes before cyclophosphamide and finishing no sooner than 12 hours after the end of the cyclophosphamide infusion, or by institutional protocol
  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day, starting 24-36 hours after Cisplatin infusion and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.

21-day cycle for 3 cycles


Consolidation

Chemotherapy, Autologous Transplant

  • Carboplatin (Paraplatin) 17 mg/kg IV over 2 hours once per day on days 1 & 2
    • If corrected GFR is < 100 ml/min/1.73m2, the Carboplatin (Paraplatin) dose should be calculated using the modified Calvert formula
  • Thiotepa (Thioplex) 10 mg/kg IV over 2 hours once per day on days 1 & 2, given immediately after carboplatin administration
    • Skincare, frequent bathing, and linen changes during Thiotepa (Thioplex) administration are important and required to avoid chemical skin burns
  • PBSC on day 4

Supportive therapy, Autologous Transplant

  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day, starting on day 5 (24 hours after infusion of PBSC) and continue until ANC > 2000/μL
    • If Filgrastim (Neupogen) is given IV, it should be administered by IV bolus over 15 to 30 minutes or by continuous infusion

28-day cycle for 3 cycles

References

  1. COG ACNS0334: Clinical Trial Registry

COG ACNS0334 Protocol B

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (COG ACNS0334) 2007-NR Phase 3 (E-esc) COG ACNS0334 Protocol A (no HD-MTX) TBD

Induction

Chemotherapy, induction

  • Vincristine (Oncovin) 0.05 mg/kg (maximum single dose of 2 mg) IV push over 1 minute or IV infusion (per institution) once per day on days 1, 8, 15
  • High Dose Methotrexate (MTX) 400 mg/kg (20 gram maximum) IV over 4 hours once on day 1
  • Etoposide (Vepesid) 2.5 mg/kg (maximum concentration is 0.4 mg/ml) IV over 60 minutes once per day on days A, B, C
    • Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
    • Begin Etoposide (Vepesid) infusion 1 hour before the Cyclophosphamide or CIS platin infusions
  • Cyclophosphamide (Cytoxan) 60 mg/kg IV over 60 minutes once per day on days A & B
    • Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
    • Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour
  • Cisplatin (Platinol) 3.5 mg/kg IV over 6 hours once on day C
    • Day A of chemotherapy begins when the serum Methotrexate (MTX) level is less than 0.1 micromolar
    • Cisplatin (Platinol) doses may require use of mannitol to augment hydration and diuresis
    • Must reduce urine specific gravity to ≤ 1.010 prior to administration and maintain urine output at greater than 3 mL/kg/hour

Supportive therapy, induction

  • Folinic acid (Leucovorin) 10 mg/m2 PO or IV every 6 hours until serum methotrexate levels are less than 0.1 micromolar
  • Mesna (Mesnex) 12 mg/kg IV five times per day on days A & B
    • Dose 1: Initial bolus dose may be administered before or at the same time as cyclophosphamide
    • Dose 2: A 3 hour infusion immediately after cyclophosphamide infusion
    • Dose 3 to 5: 3 subsequent bolus doses given at hours 6, 9, 12 or by institutional protocol
    • Mesna (Mesnex) 60 mg/kg/day may also be given as a 24 hour continuous infusion by institutional protocol
    • Day A of chemotherapy begins when the serum MTX level is less than 0.1 micromolar
  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting on day D (24-36 hours after Cisplatin infusion) and continue until ANC > 1000/μL then increase to 10 mcg/kg and plan for harvest 2 days later. If PBSC harvest after the first cycle is insufficient, then harvests may occur after the second (and third if required) cycle. If PBSC harvest is not planned, continue until ANC > 2000/μL.

21-day cycle for 3 cycles, followed by:


Consolidation

Chemotherapy, Autologous Transplan

  • Carboplatin (Paraplatin) 17 mg/kg IV over 2 hours given once per day on days 1 & 2
    • If corrected GFR is < 100 ml/min/1.73m2, the Carboplatin (Paraplatin) dose should be calculated using the modified Calvert formula
  • Thiotepa (Thioplex) 10 mg/kg IV over 2 hours once per day on days 1 & 2 immediately after carboplatin administration
    • Skincare, frequent bathing, and linen changes during Thiotepa (Thioplex) administration are important and required to avoid chemical skin burns
  • PBSC on day 4

Supportive therapy, Autologous Transplant

  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day starting on day 5 (24 hours after infusion of PBSC) and continued until ANC > 2000/μL
    • If Filgrastim (Neupogen) is given IV, it should be administered by IV bolus over 15 to 30 minutes or by continuous infusion

28-day cycle for 3 cycles

References

  1. COG ACNS0334: Clinical Trial Registry

Head Start III Protocol D2

Study Dates of enrollment Evidence
Dhall et al. 2020 (Head Start III) 2003-05 to 2009-12 Non-randomized

Induction

Chemotherapy, part A (cycles 1 & 3)

Supportive therapy, part A (cycles 1 & 3)

Chemotherapy, part B (cycles 2 & 4)

Chemotherapy, part C (cycle 5)

Supportive therapy, part C (cycle 5)

15-day cycle for 5 cycles; patients with no evidence of disease (NED) after induction or second look surgery proceed to:


Consolidation

Chemotherapy, myeloablative with autologous stem cell rescue

Stem cell re-infused on unspecified day

References

  1. Head Start III: Dhall G, O'Neil SH, Ji L, Haley K, Whitaker AM, Nelson MD, Gilles F, Gardner SL, Allen JC, Cornelius AS, Pradhan K, Garvin JH, Olshefski RS, Hukin J, Comito M, Goldman S, Atlas MP, Walter AW, Sands S, Sposto R, Finlay JL. Excellent outcome of young children with nodular desmoplastic medulloblastoma treated on "Head Start" III: a multi-institutional, prospective clinical trial. Neuro Oncol. 2020 Dec 18;22(12):1862-1872. link to original article link to PMC article PubMed Clinical Trial Registry

SJMB-96 Protocol High Risk

Protocol

Study Dates of enrollment Evidence
Gajjar et al. 2006 (SJMB-96) 1996-10 to 2003-05 Non-randomized

Chemotherapy

Supportive therapy

  • Filgrastim (Neupogen) 10 mcg/kg SC or IV (per institutional policy) mobilization prior to PBSC harvest
    • PBSC harvest after first cycle, or second cycle if first PBSC is inadequate

14-day cycle for 2 cycles

Radiotherapy

  • Craniospinal axis External beam radiotherapy by the following stage-based criteria:
    • M0 - M1: 36 Gy in 18 daily fractions
    • M2 - M3: 36 to 39.6 Gy in 18 to 22 daily fractions
      • See protocol for additional details on dose
  • Posterior fossa External beam radiotherapy 55.8 Gy in 31 daily fractions
    • Local boost External beam radiotherapy to 59.4 Gy in 33 daily fractions at investigator's option for residual tumor measuring > 1.5 cm2

~ 6 week duration, followed in 6 weeks by:

Chemotherapy, High Dose with PBSC support

Supportive therapy

  • Mesna (Mesnex) 500 mg/m2 IV push 15 minutes prior to cyclophosphamide infusion once per day on days -3 & -2
  • Mesna (Mesnex) 1500 mg/m2 IV continuous infusion on days -3, -2
  • PBSC Infusion on day 0
  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.

28-day cycle for 4 cycles

References

  1. SJMB-96: Gajjar A, Chintagumpala M, Ashley D, Kellie S, Kun LE, Merchant TE, Woo S, Wheeler G, Ahern V, Krasin MJ, Fouladi M, Broniscer A, Krance R, Hale GA, Stewart CF, Dauser R, Sanford RA, Fuller C, Lau C, Boyett JM, Wallace D, Gilbertson RJ. Risk-adapted craniospinal radiotherapy followed by high-dose chemotherapy and stem-cell rescue in children with newly diagnosed medulloblastoma (St Jude Medulloblastoma-96): long-term results from a prospective, multicentre trial. Lancet Oncol. 2006 Oct;7(10):813-820 link to original article PubMed Clinical Trial Registry
    1. Toxicity update: Laughton SJ, Merchant TE, Sklar CA, Kun LE, Fouladi M, Broniscer A, Morris EB, Sanders RP, Krasin MJ, Shelso J, Xiong Z, Wallace D, Gajjar A. Endocrine outcomes for children with embryonal brain tumors after risk-adapted craniospinal and conformal primary-site irradiation and high-dose chemotherapy with stem-cell rescue on the SJMB-96 trial. J Clin Oncol. 2008 Mar;26(7):1112-1118 link to original article PubMed

SJMB-96 Protocol Average Risk

Protocol

Study Dates of enrollment Evidence
Gajjar et al. 2006 (SJMB-96) 1996-10 to 2003-05 Non-randomized

Growth factor therapy

Radiotherapy

~ 6 week duration, followed in 6 weeks by:

Chemotherapy, High Dose with PBSC support

Supportive medications

  • Mesna (Mesnex) 500 mg/m2 IV push 15 minutes prior to cyclophosphamide infusion once per day on days -3 & -2
  • Mesna (Mesnex) 1500 mg/m2 IV continuous infusion on days -3 & -2
  • PBSC Infusion on day 0
  • Filgrastim (Neupogen) 5 mcg/kg SC or IV (per institutional policy) once per day beginning on day 1 (24-36 hours after PBSC reinfusion) and continue for at least 7 days or continue until ANC > 2000/μL for 2 consecutive days.

28-day cycle for 4 cycles

References

  1. SJMB-96: Gajjar A, Chintagumpala M, Ashley D, Kellie S, Kun LE, Merchant TE, Woo S, Wheeler G, Ahern V, Krasin MJ, Fouladi M, Broniscer A, Krance R, Hale GA, Stewart CF, Dauser R, Sanford RA, Fuller C, Lau C, Boyett JM, Wallace D, Gilbertson RJ. Risk-adapted craniospinal radiotherapy followed by high-dose chemotherapy and stem-cell rescue in children with newly diagnosed medulloblastoma (St Jude Medulloblastoma-96): long-term results from a prospective, multicentre trial. Lancet Oncol. 2006 Oct;7(10):813-820 link to original article PubMed Clinical Trial Registry
    1. Toxicity update: Laughton SJ, Merchant TE, Sklar CA, Kun LE, Fouladi M, Broniscer A, Morris EB, Sanders RP, Krasin MJ, Shelso J, Xiong Z, Wallace D, Gajjar A. Endocrine outcomes for children with embryonal brain tumors after risk-adapted craniospinal and conformal primary-site irradiation and high-dose chemotherapy with stem-cell rescue on the SJMB-96 trial. J Clin Oncol. 2008 Mar;26(7):1112-1118 link to original article PubMed
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