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Alkylating agents

Combination Chemotherapy for Ewing's Sarcoma

Phase 3
Waitlist Available
Research Sponsored by University of Leicester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed tumor of the Ewing's family of bone or soft tissue (Ewing's sarcoma, Peripheral primitive neuroectodermal tumor)
Renal function normal, Glomerular filtration rate at least 60 mL/min
Must not have
No prior chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Who is the study for?
This trial is for patients with Ewing's Sarcoma, a type of bone or soft tissue tumor. Eligible participants are under 50 years old, have tumors that can be removed by surgery (less than 200 mL), and may have certain metastases. The trial excludes those who've had a biopsy over 45 days ago or have conditions not specified here.
What is being tested?
The study tests different chemotherapy combinations with options like stem cell transplantation, radiation therapy, and surgery to see which is more effective against Ewing's Sarcoma. Patients will be randomly assigned to receive either just chemo or chemo plus other treatments.
What are the potential side effects?
Chemotherapy drugs like dactinomycin and doxorubicin can cause nausea, hair loss, mouth sores; etoposide might lead to low blood counts increasing infection risk; melphalan and busulfan could result in lung damage; ifosfamide may affect kidneys; vincristine can cause nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of Ewing's sarcoma or related.
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My kidney function is normal, with a filtration rate of 60 mL/min or more.
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My heart functions normally, with good pumping ability.
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I am younger than 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never received chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597
44%
Acute RT Toxicity: Bowel: NOS
29%
Hormone Toxicity: Hot flashes : NOS
26%
Late RT Toxicity: Bowel: NOS
24%
Hormone Toxicity: Impotence : NOS
18%
Late RT Toxicity: Bladder: NOS
17%
Hormone Toxicity: Hematologic : NOS
15%
Acute RT Toxicity: Bladder: NOS
13%
Acute RT Toxicity: Hematologic: NOS
13%
Late RT Toxicity: Hematologic: NOS
13%
Acute RT Toxicity: Other: NOS
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 2, arm IIExperimental Treatment10 Interventions
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks.
Group II: Group 2, arm IExperimental Treatment7 Interventions
Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients then receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days.
Group III: Group 1Experimental Treatment7 Interventions
Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
FDA approved
Etoposide
FDA approved
radiation therapy
1994
Completed Phase 3
~13390
Dactinomycin
FDA approved
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
Vincristine
FDA approved
Doxorubicin
FDA approved
Melphalan
FDA approved
Ifosfamide
FDA approved
conventional surgery
1994
Completed Phase 3
~13900

Find a Location

Who is running the clinical trial?

Gesellschaft fur Padiatrische Onkologie und Hamatologie - GermanyOTHER
11 Previous Clinical Trials
8,857 Total Patients Enrolled
1 Trials studying Sarcoma
195 Patients Enrolled for Sarcoma
University of LeicesterLead Sponsor
213 Previous Clinical Trials
17,751,180 Total Patients Enrolled
Gesellschaft fur Padiatrische Onkologie und Hamatologie - AustriaOTHER
1 Previous Clinical Trials
195 Total Patients Enrolled
1 Trials studying Sarcoma
195 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,110,887 Total Patients Enrolled
460 Trials studying Sarcoma
228,641 Patients Enrolled for Sarcoma
Societe Francaise Oncologie PediatriqueOTHER
4 Previous Clinical Trials
1,498 Total Patients Enrolled
1 Trials studying Sarcoma
EBMT Solid Tumors Working PartyOTHER
4 Previous Clinical Trials
1,110 Total Patients Enrolled
Children's Cancer and Leukaemia GroupOTHER
55 Previous Clinical Trials
9,498 Total Patients Enrolled
8 Trials studying Sarcoma
1,346 Patients Enrolled for Sarcoma
German Society for Pediatric Oncology and Hematology GPOH gGmbHOTHER
14 Previous Clinical Trials
13,253 Total Patients Enrolled
1 Trials studying Sarcoma
195 Patients Enrolled for Sarcoma
Swiss Group for Clinical Cancer ResearchOTHER
136 Previous Clinical Trials
19,055 Total Patients Enrolled
2 Trials studying Sarcoma
59 Patients Enrolled for Sarcoma
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
414 Previous Clinical Trials
164,410 Total Patients Enrolled
27 Trials studying Sarcoma
4,931 Patients Enrolled for Sarcoma

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00020566 — Phase 3
Sarcoma Research Study Groups: Group 1, Group 2, arm II, Group 2, arm I
Sarcoma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT00020566 — Phase 3
Busulfan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00020566 — Phase 3
~48 spots leftby Dec 2025
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