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The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma

2026년 9월 14일 업데이트: Wake Forest University Health Sciences

The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment.

The main questions this study aims to answer are:

  • Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days?
  • Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers?

Researchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels.

Participants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This Phase II, multi-institutional study evaluates the safety of hospital discharge at higher serum methotrexate (MTX) levels in children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma receiving standard-of-care high-dose methotrexate (HD-MTX) as part of MAP chemotherapy.

Participants are discharged once they meet the pre-defined MTX clearance, kidney function, and clinical safety criteria. Methotrexate discharge thresholds are evaluated using an adaptive Bayesian threshold-finding design, starting at a serum MTX level of less than or equal to 0.15 micromolar, with possible escalation or de-escalation based on observed toxicity.

Secondary objectives include comparison of hospital length of stay and estimated inpatient costs with historical controls using traditional discharge criteria. Optional correlative studies include patient-derived osteosarcoma tumor organoids and circulating tumor cells to evaluate chemotherapy sensitivity and other future research. A separate retrospective chart review of prior patients treated with HD-MTX is included to understand safety outcomes and MTX clearance patterns.

연구 유형

중재적

등록 (추정된)

46

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • University of North Carolina at Chapel Hill
        • 연락하다:
        • 수석 연구원:
          • Ian Davis, MD, PhD
      • Charlotte, North Carolina, 미국, 28204
        • Novant Health Hemby Children's Hospital
        • 수석 연구원:
          • Jessica Bell, MD
        • 연락하다:
      • Durham, North Carolina, 미국, 27710
        • Duke University Medical Center
        • 수석 연구원:
          • Jessica Sun, MD
        • 연락하다:
      • Greenville, North Carolina, 미국, 27834
        • East Carolina University
        • 연락하다:
        • 수석 연구원:
          • Andrea Whitfield, DO
      • Winston-Salem, North Carolina, 미국, 27157
        • Atrium Health Wake Forest Baptist
        • 수석 연구원:
          • Sarah Supples, MD
        • 연락하다:
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Medical University of South Carolina
        • 수석 연구원:
          • Jacqueline Kraveka, DO
        • 연락하다:
      • Columbia, South Carolina, 미국, 29203
        • Prisma Health Midlands
        • 연락하다:
        • 수석 연구원:
          • Chandni Dargan, MD
      • Greenville, South Carolina, 미국, 29605
        • Prisma Health Upstate
        • 수석 연구원:
          • Chandni Dargan, MD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Pre-Enrollment Criteria:

  1. Suspected diagnosis of high-grade osteosarcoma based on clinical and radiographic findings.
  2. Informed consent (and assent, if applicable) obtained, per institutional guidelines.
  3. Participants must be ≤ 22 years of age at the time of consent.

Inclusion Criteria:

  1. Participants with localized or metastatic high-grade osteosarcoma.
  2. Participants must be ≤ 22 years of age at the time of consent.
  3. Participants must have a body surface area of greater than or equal to 0.8 m2.

  4. Participants receiving or planning to receive induction/neoadjuvant MAP chemotherapy with HD-MTX given at the standard dose of 12 gm/m2 (maximum 20 gm).

    NOTE: Participants may be participating on other clinical studies such as the COG trial AOST2032 or any other clinical trial as long as their treatment includes MAP chemotherapy with the standard HD-MTX dose of 12 gm/m2 (maximum 20 gm).

  5. Participants may receive other chemotherapy agents in their treatment provided that drug(s) are not known to interfere with HD-MTX clearance when given concurrently. Medications known to interfere with HD-MTX clearance are listed in Appendix A.

  6. Participants must meet minimum organ function requirements to receive HD-MTX:

    • Adequate liver function defined as: total bilirubin ≤ 1.5x upper limit of normal (ULN) for age at the time of consent and alanine aminotransferase (ALT/SGPT) ≤ 135 U/L for age at the time of consent.
    • Adequate renal function defined as: a serum creatinine based on age/gender OR - a 24-hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2, OR - an estimated glomerular filtration rate (GFR) of greater than or equal to 70 mL/min/1.73 m2 for age at the time of consent.
    • Adequate bone marrow function defined as: peripheral absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment), and hemoglobin ≥ 8.0 g/dL (transfusion independent, defined as not receiving red blood cell transfusions within a 7-day period prior to enrollment)

  7. Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) ≥ 50%, assessed per institutional standard of care using non-invasive imaging modalities such as a Multi-Gated Acquisition (MUGA) scan or echocardiogram (echo).

    NOTE: Cardiac function assessment will be performed as part of routine clinical care. No additional imaging or procedures will be mandated by the research protocol.

  8. Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.
  9. Participants can enroll after initiation of induction MAP chemotherapy so long as they are enrolled prior to the second cycle of chemotherapy (prior to week 6 cisplatin and doxorubicin).
  10. Participants must be willing and able to comply with all study procedures for the entire length of the study.

Exclusion Criteria:

  1. Female participants who are pregnant and/or lactating and breast feeding their infant(s).

    NOTE: Pregnancy testing will follow institutional standard of care practice and is not mandated by the protocol.

  2. Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy, at the discretion of the investigator.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Standard-of-Care MAP Chemotherapy with Threshold-Adjusted HD-MTX Discharge
Participants with newly diagnosed high-grade osteosarcoma receive standard-of-care MAP chemotherapy, including high-dose methotrexate (HD-MTX), with hospital discharge based on serum methotrexate threshold levels (ranging from ≤0.10 µM to ≤0.20 µM) and renal function criteria to evaluate the safety of earlier discharge. Threshold levels are not randomized and are evaluated sequentially over the course of the study.
의약품: High-dose Methotrexate
High-dose methotrexate (HD-MTX) is administered intravenously at a dose of 12 g/m² (maximum dose 20 g) over 4 hours as part of standard-of-care MAP chemotherapy for participants with newly diagnosed high-grade osteosarcoma. HD-MTX is delivered with standard supportive care measures, including alkalinized intravenous hydration, serial serum methotrexate level monitoring, and leucovorin rescue beginning 24 hours after methotrexate initiation and continued until discharge criteria are met. Treatment is administered according to institutional standards throughout neoadjuvant/induction and adjuvant/consolidation therapy.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Dose Limiting Toxicity (DLT)
기간: Within 7-days post-discharge of methotrexate visit
A binary response for dose-limiting toxicity following MTX visit discharge defined as rehospitalization due to acute toxicity or serious adverse event of special interest
Within 7-days post-discharge of methotrexate visit

2차 결과 측정

결과 측정
측정값 설명
기간
Length of Stay (LOS)
기간: From time of admission to time of discharge in hours for each HD-MTX inpatient cycle, assessed across [up to] 12 cycles per participant, through completion of HD-MTX therapy (up to approximately 30 weeks per participant from first week of treatment)
Length of hospital stay measured in hours from time of admission to time of discharge for each HD-MTX inpatient cycle
From time of admission to time of discharge in hours for each HD-MTX inpatient cycle, assessed across [up to] 12 cycles per participant, through completion of HD-MTX therapy (up to approximately 30 weeks per participant from first week of treatment)
Patient Cost Per Visit
기간: Approximately 30 weeks per participant from first week of treatment
Total estimated cost associated with each HD-MTX inpatient cycle, based on hospital billing charges and nights of stay
Approximately 30 weeks per participant from first week of treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wake Forest University Health Sciences

협력자

Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

수사관

  • 수석 연구원: Thomas Russell, MD, Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 4월 16일

QC 기준을 충족하는 최초 제출

2026년 4월 23일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00081644 (Advarra IRB)
  • ARISE-CATSINDO (기타 식별자: Alliance for Research and Innovations in Pediatric Oncology (ARISE) Cancer Consortium)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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