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NCT01993810 · ClinicalTrials.gov registry record · Phase 3

Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

A Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, sponsored by Radiation Therapy Oncology Group.

Active
Registry status
Phase 3
Development phase
330
Enrollment target
20
Study locations

NCT01993810: Active Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, sponsored by Radiation Therapy Oncology Group.

NCT01993810 is a Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 that is active but no longer recruiting, run by Radiation Therapy Oncology Group. The registered enrollment target is 330 participants, above the 111-participant average among 3 other Stage II Non-Small Cell Lung Cancer AJCC v7 trials with a reported enrollment target (197% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01993810, a Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, is active but no longer recruiting, sponsored by Radiation Therapy Oncology Group.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
330 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

Primary Outcome

The time from study registration until death or last follow-up

Conditions Studied

Stage II Non-Small Cell Lung Cancer AJCC v7 Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage III Non-Small Cell Lung Cancer AJCC v7

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • BIOLOGICAL Durvalumab
  • DRUG Paclitaxel
  • DRUG Etoposide

Study Locations (20)

Maryland

  • Maryland Proton Treatment Center - Baltimore
  • University of Maryland/Greenebaum Cancer Center - Baltimore
  • Upper Chesapeake Medical Center - Bel Air
  • Central Maryland Radiation Oncology in Howard County - Columbia
  • Tate Cancer Center - Glen Burnie

New York

  • Memorial Sloan Kettering Commack - Commack
  • Memorial Sloan Kettering Westchester - Harrison
  • Memorial Sloan Kettering Cancer Center - New York
  • Memorial Sloan Kettering Rockville Centre - Rockville Centre
  • Memorial Sloan Kettering Sleepy Hollow - Sleepy Hollow

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Mass General/North Shore Cancer Center - Danvers

Missouri

  • Siteman Cancer Center at West County Hospital - Creve Coeur
  • Washington University School of Medicine - St Louis

New Jersey

  • Memorial Sloan Kettering Basking Ridge - Basking Ridge
  • ProCure Proton Therapy Center-Somerset - Somerset

Ohio

  • University of Cincinnati Medical Center - Cincinnati
  • West Chester Hospital - West Chester

Florida

  • University of Florida Health Science Center - Jacksonville - Jacksonville

Illinois

  • Northwestern Medicine Cancer Center Warrenville - Warrenville

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2014-02-03
Est. Completion 2028-10
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the registry record for NCT01993810 still lists

NCT01993810 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 111-participant average among 3 other Stage II Non-Small Cell Lung Cancer AJCC v7 trials with a reported enrollment target (197% higher).

The record links to 6 conditions, with Stage II Non-Small Cell Lung Cancer AJCC v7 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT01993810 names 20 study sites across 8 states, led by Maryland, New York, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01993810 about?

NCT01993810 is a clinical study titled "Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer". This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation di...

What is the current status of trial NCT01993810?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2014-02-03. Estimated completion is 2028-10.

What conditions does trial NCT01993810 study?

This clinical trial studies the following conditions: Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Non-Small Cell Lung Cancer AJCC v7.

What interventions are being tested in trial NCT01993810?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Durvalumab (BIOLOGICAL), Paclitaxel (DRUG), Etoposide (DRUG).

Who is sponsoring clinical trial NCT01993810?

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

Where is trial NCT01993810 being conducted?

This trial has 20 study locations across Florida, Illinois, Maryland, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01993810, the US trial registry maintained by the National Library of Medicine. NCT01993810 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.