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NCT00003857 · ClinicalTrials.gov registry record · Phase 3

Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

A Phase 3 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
636
Enrollment target

NCT00003857: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.

NCT00003857 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 636 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003857, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
636 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

Interventions

  • RADIATION radiation therapy
  • PROCEDURE adjuvant therapy
  • DRUG tamoxifen citrate

Trial Details

FieldValue
Enrollment Target 636 participants
Start Date 1999-12
Est. Completion 2022-05-20
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00003857 record still lists

NCT00003857 is an interventional study that assigns participants to a tested intervention. The registered 636 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 (18% lower).

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

NCT00003857 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003857 about?

NCT00003857 is a clinical study titled "Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effect...

What is the current status of trial NCT00003857?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 636 participants. The study started on 1999-12. Estimated completion is 2022-05-20.

What interventions are being tested in trial NCT00003857?

The interventions under investigation include: radiation therapy (RADIATION), adjuvant therapy (PROCEDURE), tamoxifen citrate (DRUG).

Who is sponsoring clinical trial NCT00003857?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00003857's enrollment target sits among peer trials

636 579th of 2000 higher than 1,422 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 NCT00003857, the US trial registry maintained by the National Library of Medicine. NCT00003857 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.