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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Study 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.Check my eligibility
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.See study design
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 in bone or soft tissue.
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I have been diagnosed with Ewing's sarcoma.
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My tumor is a type of cancer called peripheral primitive neuroectodermal and can be surgically removed.
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My cancer was surgically removed when first diagnosed.
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My tumor cannot be surgically removed but does not need immediate radiation.
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My cancer is localized and needs early radiotherapy.
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My cancer has spread only to my lungs or the lining of my lungs.
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My cancer has spread to bones, bone marrow, or lymph nodes.
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I am under 50 years old.

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival
Overall survival
Secondary outcome measures
Feasibility and toxicity of consolidation regimens at 1 month following consolidation therapy
Feasibility, toxicity, and response at 1 month following induction therapy

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

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
Dactinomycin
FDA approved
Doxorubicin
FDA approved
Etoposide
FDA approved
Melphalan
FDA approved
Busulfan
FDA approved
Ifosfamide
FDA approved
Vincristine
FDA approved
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
radiation therapy
1994
Completed Phase 3
~13390
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
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,222,600 Total Patients Enrolled
451 Trials studying Sarcoma
233,842 Patients Enrolled for Sarcoma
Societe Francaise Oncologie PediatriqueOTHER
4 Previous Clinical Trials
1,498 Total Patients Enrolled
1 Trials studying Sarcoma

Media Library

Busulfan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00020566 — Phase 3
Sarcoma Research Study Groups: Group 2, arm II, Group 1, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the governing body's official thoughts on radiation as a form of treatment?

"There is some evidence from Phase 3 clinical trials to support the efficacy of radiation therapy, as well as multiple rounds of data suggesting that it is a safe treatment option. Therefore, our team at Power has given it a safety rating of 3."

Answered by AI

What are the most common types of cancers that can be treated with radiation therapy?

"Radiation therapy is commonly used to treat small cell lung cancer, but it can also be used to manage leukemia, myelocytic, acute, neuroblastoma, and allogeneic hematopoietic stem cell transplant, chronic myelogenous leukemia."

Answered by AI

Are there any other similar research studies that use radiation therapy?

"The first documented case of radiation therapy was in 1997 at Spectrum Health Hospital - Butterworth Campus. As of now, there have been a total of 1636 completed trials. Out of these completed studies, 828 are still active with a large portion of these being in Tampa, Florida."

Answered by AI

What is the uppermost limit to the number of individuals who can join this clinical trial?

"As of now, this study is not enrolling new patients. According to the information on clinicaltrials.gov, this trial was first posted on February 1, 2001 and was last updated on June 23, 2014. However, there are 456 other trials for sarcoma and 828 trials for radiation therapy that are still admitting patients."

Answered by AI

Is this a newly proposed treatment method?

"The first radiation therapy trial was sponsored by Alfacell and was conducted in 1997. This was followed by Phase 3 approval in 1997. 828 clinical trials involving radiation therapy are currently underway in 2330 cities and 75 countries."

Answered by AI

Who else is applying?

What site did they apply to?
Albert Einstein Cancer Center at Albert Einstein College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~50 spots leftby Feb 2025