Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00354744 · ClinicalTrials.gov registry record · Phase 3
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
NCT00354744: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00354744 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354744, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.
Primary Outcome
Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of t
Interventions
- DRUG cyclophosphamide
- DRUG etoposide
- DRUG ifosfamide
- DRUG doxorubicin hydrochloride
- BIOLOGICAL dactinomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2006-07 |
| Est. Completion | 2019-06-30 |
| Phase | Phase 3 |
What the finished NCT00354744 record still lists
NCT00354744 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00354744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00354744 about?
NCT00354744 is a clinical study titled "High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma". RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy ...
What is the current status of trial NCT00354744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2006-07. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT00354744?
The interventions under investigation include: cyclophosphamide (DRUG), etoposide (DRUG), ifosfamide (DRUG), doxorubicin hydrochloride (DRUG), dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00354744?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00354744's enrollment target sits among peer trials
109 1664th of 2000 higher than 337 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02421380 · 109 participants · NA
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
- NCT04526600 · 109 participants · NA
Fidgeting and Attentional and Emotional Regulation in ADHD
- NCT04835584 · 109 participants · Phase 1
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- NCT06626516 · 109 participants · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia