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NCT01076231 · ClinicalTrials.gov registry record · Phase 1

Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT01076231: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

NCT01076231 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01076231, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving proton beam radiation therapy together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of proton beam radiation therapy when given together with cisplatin and etoposide and to see how well it works in treating patients with stage III non-small cell lung cancer that can be removed by surgery.

Primary Outcome

Feasibility will be based on multiple radiation planning and treatment parameters. Study will be deemed feasible if all patients are deemed feasible.

Interventions

  • DRUG cisplatin
  • PROCEDURE therapeutic conventional surgery
  • DRUG etoposide
  • RADIATION proton beam radiation therapy

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2010-01
Est. Completion 2018-05-24
Phase Phase 1

What the finished NCT01076231 record still lists

NCT01076231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.

NCT01076231 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01076231 about?

NCT01076231 is a clinical study titled "Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery". RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in chemotherapy, such as cisplatin an...

What is the current status of trial NCT01076231?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-01. Estimated completion is 2018-05-24.

What interventions are being tested in trial NCT01076231?

The interventions under investigation include: cisplatin (DRUG), therapeutic conventional surgery (PROCEDURE), etoposide (DRUG), proton beam radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT01076231?

This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01076231's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01076231, the US trial registry maintained by the National Library of Medicine. NCT01076231 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.