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NCT00346164 · ClinicalTrials.gov registry record · Phase 3
Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 588
- Enrollment target
NCT00346164: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00346164 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 588 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00346164, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 588 participants
- Enrollment target
Study Summary
This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Primary Outcome
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Interventions
- PROCEDURE therapeutic conventional surgery
- DRUG ifosfamide
- RADIATION 3-dimensional conformal radiation therapy
- DRUG doxorubicin hydrochloride
- OTHER clinical observation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 588 participants |
| Start Date | 2007-02-05 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 3 |
What the finished NCT00346164 record still lists
NCT00346164 is an interventional study that assigns participants to a tested intervention. The registered 588 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 (24% lower).
The record links to 0 conditions, and to 5 interventions - of which therapeutic conventional surgery is the first listed.
NCT00346164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00346164 about?
NCT00346164 is a clinical study titled "Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma". This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor...
What is the current status of trial NCT00346164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 588 participants. The study started on 2007-02-05. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT00346164?
The interventions under investigation include: therapeutic conventional surgery (PROCEDURE), ifosfamide (DRUG), 3-dimensional conformal radiation therapy (RADIATION), doxorubicin hydrochloride (DRUG), clinical observation (OTHER).
Who is sponsoring clinical trial NCT00346164?
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 NCT00346164's enrollment target sits among peer trials
588 645th of 2000 higher than 1,356 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
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