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NCT00001300 · ClinicalTrials.gov registry record · Phase 3

A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
150
Enrollment target

NCT00001300: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00001300 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001300, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
150 participants
Enrollment target

Study Summary

Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A. Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment with or without electron boost. Arm I: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation and Urothelial Protection. Doxorubicin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629; and Mesna, NSC-113891. Arm II: Observation. No adjuvant chemotherapy.

Interventions

  • DRUG doxorubicin
  • DRUG ifosfamide
  • DRUG mesna

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 1992-06
Est. Completion 2001-03
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001300 record still lists

NCT00001300 is an interventional study that assigns participants to a tested intervention. The registered 150 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 (81% lower).

The record links to 0 conditions, and to 3 interventions - of which doxorubicin is the first listed.

NCT00001300 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001300 about?

NCT00001300 is a clinical study titled "A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma". Randomized study. All patients must be randomized to treatment on Arms I and II within 3 months of definitive surgery on Regimen A. Regimen A: Surgery followed, as indicated, by Radiotherapy. Amputation; or limb-sparing resection followed by involved-field irradiation using megavoltage equipment wi...

What is the current status of trial NCT00001300?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 1992-06. Estimated completion is 2001-03.

What interventions are being tested in trial NCT00001300?

The interventions under investigation include: doxorubicin (DRUG), ifosfamide (DRUG), mesna (DRUG).

Who is sponsoring clinical trial NCT00001300?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001300's enrollment target sits among peer trials

150 1519th of 2000 higher than 455 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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Source: ClinicalTrials.gov NCT00001300, the US trial registry maintained by the National Library of Medicine. NCT00001300 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.