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Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01882816
First received: June 13, 2013
Last updated: September 9, 2014
Last verified: September 2014

June 13, 2013
September 9, 2014
June 2013
June 2015   (final data collection date for primary outcome measure)
rates of local-regional progression-free interval [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01882816 on ClinicalTrials.gov Archive Site
  • overall survival rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rates of acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events—Version 4.0
  • rates of late dysphagia, dry mouth, and other toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events—Version 4.0
  • Objective measures of late dysphagia [ Time Frame: pre-treatment, 6 months, 12, months, 18 months, and 24 months post-treatment. ] [ Designated as safety issue: No ]
    using standard Modified Barium Swallow-Imp and Penetration-Aspiration scale
Same as current
Not Provided
Not Provided
 
Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer

The purpose of this Phase 2 study is to find out what effect, good and/or bad, external beam radiation therapy, has on the patient and their thyroid cancer where surgery is not an option or where despite surgery, the disease is still present.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroid Cancer
  • Radiation: IMRT
    Pts will undergo baseline history & physical exam & laboratory studies as part of initial assessment for protocol eligibility. Baseline imaging will include FDG PET/CT scan, according to our standard of care. Pts will provide written informed consent. Pts will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Pts will be seen weekly during radiation as per standard procedure at MSKCC. Approximately 3 months after completion of radiation, radiologic response assessment will be performed as per our standard guideline. This will include a FDG PET/CT scan, as well as a recommended cross-sectional imaging of the primary tumor (with CT scan &/or MRI). Clinic visits will take place approximately every 3 months for 2 years, approximately every 6 months for the next 3 years, & approximately annually thereafter.
  • Device: DWI MRI
    A recommended DW and multiparametric MRI will also take place approximately weekly unless contraindicated for Main Campus patients only . The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.
  • Drug: Doxorubicin
    Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.
Experimental: IMRT and doxorubicin
All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.
Interventions:
  • Radiation: IMRT
  • Device: DWI MRI
  • Drug: Doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
  • Age ≥18 years
  • Karnofsky performance status ≥70%
  • Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
  • Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Inability to comply with study and/or follow-up procedures
Both
18 Years and older
No
Contact: Nancy Lee, MD 212-639-3341
Contact: Eric Sherman, MD 646-888-4234
United States
 
NCT01882816
13-070
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Nancy Lee, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP