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NCT00004123 · ClinicalTrials.gov registry record · Phase 1

Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT00004123: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00004123 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004123, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus doxorubicin in treating patients who have resectable primary or recurrent peritoneal soft tissue sarcoma.

Primary Outcome

The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity

Interventions

  • RADIATION Radiation Therapy (RT)
  • RADIATION Intraoperative radiation therapy (IORT)
  • PROCEDURE Conventional surgery
  • DRUG Doxorubicin hydrochloride (DOX)

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 1997-07
Est. Completion 2009-10
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00004123 record still lists

NCT00004123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 4 interventions - of which Radiation Therapy (RT) is the first listed.

NCT00004123 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004123 about?

NCT00004123 is a clinical study titled "Radiation Therapy Plus Doxorubicin in Treating Patients With Resectable Primary or Recurrent Retroperitoneal Soft Tissue Sarcoma". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effec...

What is the current status of trial NCT00004123?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 1997-07. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00004123?

The interventions under investigation include: Radiation Therapy (RT) (RADIATION), Intraoperative radiation therapy (IORT) (RADIATION), Conventional surgery (PROCEDURE), Doxorubicin hydrochloride (DOX) (DRUG).

Who is sponsoring clinical trial NCT00004123?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004123's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 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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Source: ClinicalTrials.gov NCT00004123, the US trial registry maintained by the National Library of Medicine. NCT00004123 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.