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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
  Purpose

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.


Condition Intervention Phase
Thyroid Cancer
Radiation: IMRT
Device: DWI MRI
Drug: Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • rates of local-regional progression-free interval [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882816

Contacts
Contact: Nancy Lee, MD 212-639-3341
Contact: Eric Sherman, MD 646-888-4234

Locations
United States, New Jersey
Memorial Sloan-Kettering Cancer Center at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States
Contact: Nancy Lee, MD    212-639-3341      
United States, New York
Memorial Sloan-Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Lee, MD    212-639-3341      
Contact: Eric Sherman, MD    646-888-4234      
Principal Investigator: Nancy Lee, MD         
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Nancy Lee, MD    212-639-3341      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Nancy Lee, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01882816     History of Changes
Other Study ID Numbers: 13-070
Study First Received: June 13, 2013
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
non-anaplastic
non-medullary
radiation
IMRT
Doxorubicin
13-070

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014