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NCT00165503 · ClinicalTrials.gov registry record · Phase 2

Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

A Phase 2 study, sponsored by Dana-Farber Cancer Institute.

Terminated
Registry status
Phase 2
Development phase
16
Enrollment target

NCT00165503: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.

NCT00165503 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00165503, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.

TERMINATED
Registry status
Phase 2
Development phase
16 participants
Enrollment target

Study Summary

The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.

Primary Outcome

Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.

Interventions

  • DRUG Cisplatin
  • DRUG ALIMTA
  • DRUG Sodium Thiosulfate

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2004-04
Est. Completion 2010-07
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

Why NCT00165503 stopped before completion

NCT00165503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).

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

NCT00165503 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00165503 about?

NCT00165503 is a clinical study titled "Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate". The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cis...

What is the current status of trial NCT00165503?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2004-04. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00165503?

The interventions under investigation include: Cisplatin (DRUG), ALIMTA (DRUG), Sodium Thiosulfate (DRUG).

Who is sponsoring clinical trial NCT00165503?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00165503's enrollment target sits among peer trials

16 1908th of 2000 higher than 82 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 NCT00165503, the US trial registry maintained by the National Library of Medicine. NCT00165503 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.