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RecruitingLast updated: 30 January 2024

rEEcur: This phase II/III trial is comparing four widely used chemotherapy regimens for patients with primary refractory and recurrent Ewing SarcomaInternational Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma

Clinical summary

Summary

In this trial, patients will be randomised to one of four chemotherapy regimens in order to identify which treatment is the best fit for future use. All four arms are currently standard of care treatment options and will be administered as follows: (Arm 1) Topotecan and Cyclophosphamide (TC): 6 cycles of 21 days, additional cycles at clinician's discretion. IV Infusoion of Topotecan 0.75mg/m2 and Cyclophosphamide 250mg/m2 on day 1, 2, 3, 4, 5. (Arm 2) Irinotecan and Temozolomide (IT): 6 cycles of 21 days, additional cycles at clinician's discretion. IV infusion of Irinotecan 50mg/m2 on days 1, 2, 3, 4, 5 Temozolomide 100mg/m2 orally on days 1, 2, 3, 4, 5 (Arm 3) Gemcitabine and Docetaxel (GD): 6 cycles of 21 days, additional cycles at clinician's discretion. IV infusion of Gemcitabine 900mg/m2 on days 1, 8. IV infusion of Docetxal 800mg/m2 on day 8. (Arm 4) High dose Ifosfamide (IFOS): 4 cycles of 21 days. IV infusion of Ifosfamide 3g/m2 on days 1, 2, 3, 4, 5.

Conditions

This trial is treating patients with Ewing Sarcoma

Cancer

Sarcoma Cancers Sarcoma

Age

People4 - 50

Phase

II/III

Trial Acronym

rEEcur

More information

Trial Identifiers

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Trial sponsor

Canteen - Australian Young Cancer Patient Clinical Trials Initiative

Scientific Title

International Randomised Controlled Trial of Chemotherapy for the Treatment of Recurrent and Primary Refractory Ewing Sarcoma

Eligibility

Inclusion

1. Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosis or disease progression.
2. Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.
3. Age greater than or equal to 2 years.
4. Eligible for randomisation between at least two open study arms.
5. Patient assessed as medically fit to receive trial treatment
6. Date of planned randomisation within 4 weeks of baseline imaging.
7. Documented negative pregnancy test for female patients of childbearing potential.
8. Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.
9. Written informed consent from the patient and/or parent/legal guardian.

Exclusion

1. Absolute Neutrophil Count (ANC) <1.0 x 109/L or platelets <75 x 109/L.
2. Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.
3. Myeloablative therapy within previous eight weeks.
4. Radiotherapy to target lesion within previous six weeks.
5. Pregnant or breastfeeding women.
6. Follow-up not possible due to social, geographic or psychological reasons.
7. Previous randomisation into the rEECur trial

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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