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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Hormone Toxicity: Liver : NOS

Late RT Toxicity: Other: NOS

Late RT Toxicity: Other GU: NOS

100%

80%

60%

40%

20%

Study treatment Arm

Neoadjuvant TAS 2 Months Before and During RT

Radiation Therapy Alone

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

Etoposide

FDA approved

Dactinomycin

FDA approved

Busulfan

FDA approved

autologous hematopoietic stem cell transplantation

2003

Completed Phase 3

~1990

Vincristine

FDA approved

Doxorubicin

FDA approved

Melphalan

FDA approved

Ifosfamide

FDA approved

radiation therapy

1994

Completed Phase 3

~13390

conventional surgery

1994

Completed Phase 3

~13900

0 / 4Eligibility criteria met

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

202 Previous Clinical Trials

17,749,522 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

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

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