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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 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 588 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00346164
The ClinicalTrials.gov registry entry for NCT00346164 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 588 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which therapeutic conventional surgery is the first listed.
NCT00346164 reports 0 study locations.
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.
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