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Section editor transclusions This page contains studies that were specific to pediatric populations. For the more general Ewing sarcoma page, follow this link.
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Upfront Therapy

COG AEWS1031 Regimen A

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Leavey et al. 2021 (COG AEWS1031)	2010-11-22 to 2016-01-04	Phase 3 (C)	COG AEWS1031 Regimen B	Did not meet co-primary endpoints of EFS/OS

Note: Regimen A is a standard 17-week regimen consisting of induction and continuation.

Induction

Chemotherapy, VDC portion (cycles 1, 3, 5)

Vincristine (Oncovin) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 1.5 mg/m² (maximum dose of 2 mg) IV push once per day on days 1 & 8
- Less than 10 kg or younger than 12 months: 0.05 mg/kg IV push once per day on days 1 & 8
Doxorubicin (Adriamycin) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 37.5 mg/m² IV push/infusion over 1 to 15 minutes once per day on days 1 & 2
- Less than 10 kg or younger than 12 months: 1.25 mg/kg IV push/infusion over 1 to 15 minutes once per day on days 1 & 2
  - Administer at a concentration not to exceed 2 mg/mL. Doxorubicin should be administered through the tubing of rapidly infusing solution of D5W or 0.9% NaCl, and it should not be infused into a large vein
Cyclophosphamide (Cytoxan) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 1200 mg/m² IV over 30 to 60 minutes once on day 1
- Less than 10 kg or younger than 12 months: 40 mg/kg IV over 30 to 60 minutes once on day 1
  - May be administered as undiluted drug (20 mg/mL, reconstitute with 0.9% NaCl to avoid hypotonic solution) or further diluted

Supportive therapy, VDC portion (cycles 1, 3, 5)

Mesna (Mesnex) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 720 mg/m² IV infusion or IV/PO with cyclophosphamide once on day 1
- Less than 10 kg or younger than 12 months: 24 mg/kg IV infusion or IV/PO with cyclophosphamide once on day 1

Chemotherapy, IE portion (cycles 2, 4, 6)

Ifosfamide (Ifex) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 1800 mg/m² IV over 60 minutes once per day on days 1 to 5
- Less than 10 kg or younger than 12 months: 60 mg/kg IV over 60 minutes once per day on days 1 to 5
  - Achieve urine specific gravity less than or equal to 1.010 before starting ifosfamide.
Etoposide (Vepesid) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 100 mg/m² IV over 1 to 2 hours once per day on days 1 to 5
- Less than 10 kg or younger than 12 months: 3.3 mg/kg IV over 1 to 2 hours once per day on days 1 to 5

Supportive therapy, IE portion (cycles 2, 4, 6)

Mesna (Mesnex) by the following age- and weight-based criteria:
- At least 10 kg and at least 12 months: 1080 mg/m² IV infusion or IV/PO with ifosfamide once per day on days 1 to 5
- Less than 10 kg or younger than 12 months: 36 mg/kg IV infusion or IV/PO with ifosfamide once per day on days 1 to 5

14-day cycle for 6 cycles, followed by:

Continuation

To be completed

References

COG AEWS1031: Leavey PJ, Laack NN, Krailo MD, Buxton A, Randall RL, DuBois SG, Reed DR, Grier HE, Hawkins DS, Pawel B, Nadel H, Womer RB, Letson GD, Bernstein M, Brown K, Maciej A, Chuba P, Ahmed AA, Indelicato DJ, Wang D, Marina N, Gorlick R, Janeway KA, Mascarenhas L. Phase III Trial Adding Vincristine-Topotecan-Cyclophosphamide to the Initial Treatment of Patients With Nonmetastatic Ewing Sarcoma: A Children's Oncology Group Report. J Clin Oncol. 2021 Dec 20;39(36):4029-4038. Epub 2021 Oct 15. Erratum in: J Clin Oncol. 2022 Jul 20;40(21):2393. link to original article link to PMC article PubMed NCT01231906

@@ Line 33: / Line 33: @@
 ===Induction===
 <div class="toccolours" style="background-color:#b3e2cd">
-====Chemotherapy, VDC portion====
+====Chemotherapy, VDC portion (cycles 1, 3, 5)====
-*[[Vincristine (Oncovin)]] as follows:
+*[[Vincristine (Oncovin)]] by the following age- and weight-based criteria:
-**Cycles 1, 3, 5: 1.5 mg/m<sup>2</sup>/dose (maximum dose of 2 mg) IV push once per day on day 1 of weeks 1, 2, 5, 6, 9 & 10
+**At least 10 kg and at least 12 months: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once per day on days 1 & 8
-***For children < 10 kg or < 1 year, the dose is 0.05 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 0.05 mg/kg IV push once per day on days 1 & 8
-*[[Doxorubicin (Adriamycin)]] as follows:
+*[[Doxorubicin (Adriamycin)]] by the following age- and weight-based criteria:
-**Cycles 1, 3, 5: 37.5 mg/m<sup>2</sup>/dose IV push/infusion over 1 to 15 minutes on days 1 and 2 of weeks 1, 5 and 9.
+**At least 10 kg and at least 12 months: 37.5 mg/m<sup>2</sup> IV push/infusion over 1 to 15 minutes once per day on days 1 & 2
-***For children < 10 kg or < 1 year, the dose is 1.25 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 1.25 mg/kg IV push/infusion over 1 to 15 minutes once per day on days 1 & 2
-***Administer at a concentration not to exceed 2 mg/mL. [[Doxorubicin (Adriamycin)]] should be administered through the tubing of rapidly infusing solution of D5W or 0.9% NaCl, and it should not be infused into a large vein
+***Administer at a concentration not to exceed 2 mg/mL. Doxorubicin should be administered through the tubing of rapidly infusing solution of D5W or 0.9% NaCl, and it should not be infused into a large vein
-*[[Cyclophosphamide (Cytoxan)]] as follows:
+*[[Cyclophosphamide (Cytoxan)]] by the following age- and weight-based criteria:
-**Cycles 1, 3, 5: 1200 mg/m<sup>2</sup>/dose IV over 30 to 60 minutes on day 1 of weeks 1, 5 and 9
+**At least 10 kg and at least 12 months: 1200 mg/m<sup>2</sup> IV over 30 to 60 minutes once on day 1
-***For children < 10 kg or < 1 year, the dose is 40 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 40 mg/kg IV over 30 to 60 minutes once on day 1
 ***May be administered as undiluted drug (20 mg/mL, reconstitute with 0.9% NaCl to avoid hypotonic solution) or further diluted
-====Supportive therapy, VDC portion====
+====Supportive therapy, VDC portion (cycles 1, 3, 5)====
-*[[Mesna (Mesnex)]] as follows:
+*[[Mesna (Mesnex)]] by the following age- and weight-based criteria:
-**Cycles 1, 3, 5: 720 mg/m<sup>2</sup>/day by IV infusion or IV/PO with cyclophosphamide on day 1 of weeks 1, 5 and 9
+**At least 10 kg and at least 12 months: 720 mg/m<sup>2</sup> IV infusion or IV/PO with cyclophosphamide once on day 1
-***For children < 10 kg or < 1 year, the dose is 24 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 24 mg/kg IV infusion or IV/PO with cyclophosphamide once on day 1
-====Chemotherapy, IE portion====
+====Chemotherapy, IE portion (cycles 2, 4, 6)====
-*[[Ifosfamide (Ifex)]] as follows:
+*[[Ifosfamide (Ifex)]] by the following age- and weight-based criteria:
-**Cycles 2, 4, 6: 1800 mg/m<sup>2</sup>/dose IV infusion over 1 hour on days 1, 2, 3, 4, and 5 of Weeks 3, 7 and 11
+**At least 10 kg and at least 12 months: 1800 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 to 5
-***For children < 10 kg or < 1 year, the dose is 60 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 60 mg/kg IV over 60 minutes once per day on days 1 to 5
-***Achieve urine specific gravity ≤ 1.010 before starting ifosfamide.
+***Achieve urine specific gravity less than or equal to 1.010 before starting ifosfamide.
-*[[Etoposide (Vepesid)]] as follows:
+*[[Etoposide (Vepesid)]] by the following age- and weight-based criteria:
-**Cycles 2, 4, 6: 100 mg/m<sup>2</sup>/dose IV infusion over 1 to 2 hours once on days 1, 2, 3, 4, and 5 of weeks 3, 7 and 11
+**At least 10 kg and at least 12 months: 100 mg/m<sup>2</sup> IV over 1 to 2 hours once per day on days 1 to 5
-***For children < 10 kg or < 1 year, the dose is 3.3 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 3.3 mg/kg IV over 1 to 2 hours once per day on days 1 to 5
-====Supportive therapy, IE portion====
+====Supportive therapy, IE portion (cycles 2, 4, 6)====
-*[[Mesna (Mesnex)]] as follows:
+*[[Mesna (Mesnex)]] by the following age- and weight-based criteria:
-**Cycles 2, 4, 6: 1080 mg/m<sup>2</sup>/day by IV infusion or IV/PO with ifosfamide on days 1, 2, 3, 4, and 5 of Weeks 3, 7 and 11
+**At least 10 kg and at least 12 months: 1080 mg/m<sup>2</sup> IV infusion or IV/PO with ifosfamide once per day on days 1 to 5
-***For children < 10 kg or < 1 year, the dose is 36 mg/kg/dose
+**Less than 10 kg or younger than 12 months: 36 mg/kg IV infusion or IV/PO with ifosfamide once per day on days 1 to 5
 '''14-day cycle for 6 cycles, followed by:'''
 </div></div><br>

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