Could extra chemo drugs boost ewing sarcoma survival?
NCT ID NCT01864109
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether adding two chemotherapy drugs, irinotecan and temozolomide, to the standard treatment for newly diagnosed Ewing sarcoma can improve outcomes. The study includes 83 patients aged 1 to 40. Researchers hope the extra drugs will help prevent the cancer from returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Irinotecan and temozolomide (chemotherapy drugs)
- What this could lead to
- If successful, this could improve the chance of keeping Ewing sarcoma from coming back after standard treatment.
- What could go wrong
- This is a phase II trial, so it is still early. Adding more chemotherapy may increase side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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83 people
The number who actually took part.
- Start date
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May 2013
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age greater than or equal to one year and less than or equal to 40 years at the time of diagnosis * Newly diagnosed, previously untreated patients with histologically or molecularly confirmed Ewing sarcoma * Adequate hematologic function: * Absolute neutrophil count ≥ 1,000/K/mcl * Platelet count ≥ 100,000/Kmcl * Adequate renal function: * Normal creatinine for age (See table below) OR * Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 Age(Years) Maximum Serum Creatinine (mg/dL) ≤ 5 0.8 6 to ≤ 10 1 11 to ≤ 15 1.2 ≥ 16 1.5 Adequate hepatic function: * Total bilirubin ≤ 1.5 x the ULN * AST ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\] * ALT ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\] Normal cardiac function: * Shortening fraction ≥ 28% by echocardiogram OR * Left ventricular ejection fraction (LVEF) ≥ 50% on technetium- 99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram * Patients must consent to an indwelling central venous catheter. * Sexually active patients of reproductive potential must be willing to use an effective method of contraception. Exclusion Criteria: * Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway) * Pregnant or breastfeeding females
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States