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NCT00068406 · ClinicalTrials.gov registry record · Phase 2

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva

A Phase 2 study, sponsored by Gynecologic Oncology Group.

Completed
Registry status
Phase 2
Development phase
61
Enrollment target

NCT00068406: Completed Phase 2 study, sponsored by Gynecologic Oncology Group.

NCT00068406 is a Phase 2 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00068406, a Phase 2 study, has completed, sponsored by Gynecologic Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin 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. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

Primary Outcome

Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.

Interventions

  • DRUG Cisplatin
  • PROCEDURE Conventional Surgery
  • RADIATION 3-Dimensional Conformal Radiation Therapy

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2005-01
Est. Completion 2012-01-20
Phase Phase 2
Gynecologic Oncology Group

154 total trials

What the finished NCT00068406 record still lists

NCT00068406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

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

NCT00068406 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00068406 about?

NCT00068406 is a clinical study titled "Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva". This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing o...

What is the current status of trial NCT00068406?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2005-01. Estimated completion is 2012-01-20.

What interventions are being tested in trial NCT00068406?

The interventions under investigation include: Cisplatin (DRUG), Conventional Surgery (PROCEDURE), 3-Dimensional Conformal Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT00068406?

This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00068406's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00068406, the US trial registry maintained by the National Library of Medicine. NCT00068406 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.