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NCT00004109 · ClinicalTrials.gov registry record · Phase 1
Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00004109: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00004109 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004109, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.
Primary Outcome
MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity
Interventions
- DRUG Doxorubicin Hydrochloride
- RADIATION Radiation Therapy (RT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1998-03 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00004109 record still lists
NCT00004109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Doxorubicin Hydrochloride is the first listed.
NCT00004109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004109 about?
NCT00004109 is a clinical study titled "Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effec...
What is the current status of trial NCT00004109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1998-03. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00004109?
The interventions under investigation include: Doxorubicin Hydrochloride (DRUG), Radiation Therapy (RT) (RADIATION).
Who is sponsoring clinical trial NCT00004109?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004109's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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