Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Secondary endpoints: 1 to 2v24
  2. Results first posted: Jul 27, 2017
    • Primary endpoint revised
    • Secondary endpoint revised
    v23
  3. Trial status: Active, Not Recruiting to Completedv22
  4. Primary completion date changed from estimate of Jul 2015 to May 2015
    • Study completion date: Jul 2015 to Dec 2015
    • Study arms: 0 to 1
    v21
  5. Primary completion date: Feb 2012 to Jul 2015
    • Study completion date: Aug 2012 to Jul 2015
    • Secondary endpoints: 2 to 1
    v20
Show 18 earlier versionsHide 18 earlier versions
  1. Primary completion date: Jun 2010 to Feb 2012
    • Study completion date: Jun 2012 to Aug 2012
    v19
  2. Enrollment target: estimated 20 to confirmed 21v18
  3. Primary completion date changed from estimate of Aug 2010 to Jun 2010
    • Study completion date: Aug 2010 to Jun 2012
    v17
  4. Primary and study completion dates: Jan 2010 to Aug 2010
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  5. Re-verified, no change to tracked fieldsv15
  6. Primary and study completion dates: May 2009 to Jan 2010v14
  7. Re-verified, no change to tracked fieldsv13
  8. Interventions: Erlotinib (Drug), Intra-arterial Cisplatin (Drug), Radiation Therapy (Radiation) to Erlotinib (Tarceva) (Drug), Intra-arterial Cisplatin (PLAT) (Drug), Radiation Therapy (RAD) (Radiation)
    • Study description expanded, about 2 words
    v12
  9. Re-verified, no change to tracked fieldsv11
  10. Trial status: Suspended to Recruiting
    • Site details revised
    v10
  11. Trial status: Recruiting to Suspended Sponsor's reason: Temporary suspension of enrollment awaiting DSMB review of safety data.
    • Site details revised
    v9
  12. Primary and study completion dates: May 2008 to May 2009
    • Primary endpoints: 0 to 1
    • Interventions: Erlotinib (Drug), Intra-arterial Cisplatin (Drug), Radiation Therapy (Procedure) to Erlotinib (Drug), Intra-arterial Cisplatin (Drug), Radiation Therapy (Radiation)
    • Secondary endpoints revised (2)
    v8
  13. Primary endpoints: 1 to 0
    • Primary completion date: May 2008
    v7
  14. Re-verified, no change to tracked fieldsv6
  15. Study completion date: Dec 2007 to May 2008v5
  16. Trial status: Suspended to Recruiting
    • Study sites: 0 to 1
    • Study completion date: May 2007 to Dec 2007
    v4
  17. Trial status: Not Yet Recruiting to Suspendedv3
  18. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer
Trial Details
NCT Number NCT00304278
Lead Sponsor Southern Illinois University
Collaborators: Genentech, Inc., OSI Pharmaceuticals
Conditions
(from sponsor)		 Head and Neck Cancer
Related terms Head and Neck Neoplasms
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov