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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Secondary endpoints: 1 to 2

    Show what changed: Secondary endpoints
    Disease Free Survival at 1year

    Study Identification, Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results), Adverse Eventsv24

  2. Notable

    Results first posted: Jul 27, 2017

    Primary endpoint revised; Secondary endpoint revised

    Show what changed: Primary endpoints
    Change in largest diameterNumber of tumorParticipants lesionWith usingComplete and Partial Response Using RECIST criteriaCriteria
    Show what changed: Secondary endpoints
    ResponseSurvival andPost progression post treatmentTreatment

    Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv23

  3. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Statusv22

  4. Minor

    Primary completion date changed from estimate of Jul 2015 to May 2015

    Completion date: Jul 2015 to Dec 2015; Study arms: 0 to 1

    Study Status, Arms and Interventionsv21

  5. Notable

    Primary completion date: Feb 2012 to Jul 2015

    Completion date: Aug 2012 to Jul 2015; Secondary endpoints: 2 to 1

    Show what changed: Secondary endpoints
    Various toxicities

    Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, Contacts/Locationsv20

Show 18 earlier versions

  1. Notable

    Primary completion date: Jun 2010 to Feb 2012

    Completion date: Jun 2012 to Aug 2012

    Study Statusv19

  2. Minor

    Enrollment target: estimated 20 to confirmed 21

    Study Status, Study Description, Study Designv18

  3. Minor

    Primary completion date changed from estimate of Aug 2010 to Jun 2010

    Completion date: Aug 2010 to Jun 2012

    Study Identification, Study Statusv17

  4. Notable

    Primary and study completion dates: Jan 2010 to Aug 2010

    Trial status: Recruiting to Active, Not Recruiting; Site details revised

    Study Status, Contacts/Locationsv16

  5. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v15

  6. Notable

    Primary and study completion dates: May 2009 to Jan 2010

    Study Statusv14

  7. Minor

    Study Status

    Re-verified, no change to tracked fields

    v13

  8. Minor

    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

    Show what changed: Study description
    [...] ell survival signals, such as AKT, and may be overcome when Erlotinib (Tarceva) is co-administered with RADiation and cisPLATin (intraarterial chemotherapy and radiation).

    Study Status, Study Description, Arms and Interventionsv12

  9. Minor

    Study Status

    Re-verified, no change to tracked fields

    v11

  10. Notable

    Trial status: Suspended to Recruiting

    Site details revised

    Study Status, Contacts/Locationsv10

  11. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: Temporary suspension of enrollment awaiting DSMB review of safety data.

    Site details revised

    Study Status, Contacts/Locationsv9

  12. Notable

    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)

    Show what changed: Primary endpoints
    Change in largest diameter of tumor lesion using RECIST criteria
    Show what changed: Secondary endpoints
    ToResponse determineand theprogression ratepost oftreatment Various locoregional control To measure the level of functiontoxicities

    Study Status, Arms and Interventions, Outcome Measures, Contacts/Locationsv8

  13. Notable

    Primary endpoints: 1 to 0

    Primary completion date: May 2008

    Show what changed: Primary endpoints
    To determine the safety and efficacy for patients with locally advanced T3-4 head and neck SCCA treated with RADPLAT and Erlotinib.

    Study Status, Sponsor/Collaborators, Outcome Measuresv7

  14. Minor

    Study Status

    Re-verified, no change to tracked fields

    v6

  15. Minor

    Completion date: Dec 2007 to May 2008

    Study Statusv5

  16. Notable

    Trial status: Suspended to Recruiting

    Study sites: 0 to 1; Completion date: May 2007 to Dec 2007

    Study Status, Oversight, Study Design, Contacts/Locationsv4

  17. Stopped

    Trial status: Not Yet Recruiting to Suspended

    Study Status, Contacts/Locationsv3

  18. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    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 Head and Neck Cancer
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov