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NCT00068419 · ClinicalTrials.gov registry record · Phase 2

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

A Phase 2 study of Desmoid Tumor, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT00068419: Completed Phase 2 study of Desmoid Tumor, sponsored by Children's Oncology Group.

NCT00068419 is a Phase 2 study of Desmoid Tumor that has completed, run by Children's Oncology Group. The registered enrollment target is 70 participants, roughly in line with the 72-participant average among 4 other Desmoid Tumor trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00068419, a Phase 2 study of Desmoid Tumor, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.

Primary Outcome

Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.

Conditions Studied

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG tamoxifen citrate
  • DRUG sulindac

Study Locations (1)

California

  • Children's Oncology Group - Monrovia

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2004-02
Est. Completion 2010-04-26
Phase Phase 2
Children's Oncology Group

342 total trials

What the finished NCT00068419 record still lists

NCT00068419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, roughly in line with the 72-participant average among 4 other Desmoid Tumor trials with a reported enrollment target.

The record links to 1 condition, with Desmoid Tumor appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT00068419 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00068419 about?

NCT00068419 is a clinical study titled "Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor". This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use ...

What is the current status of trial NCT00068419?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2004-02. Estimated completion is 2010-04-26.

What conditions does trial NCT00068419 study?

This clinical trial studies the following conditions: Desmoid Tumor.

What interventions are being tested in trial NCT00068419?

The interventions under investigation include: laboratory biomarker analysis (OTHER), tamoxifen citrate (DRUG), sulindac (DRUG).

Who is sponsoring clinical trial NCT00068419?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00068419 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00068419, the US trial registry maintained by the National Library of Medicine. NCT00068419 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.