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Completed

NCT Number: NCT01882816

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMRT

Radiation

Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC

DWI MRI

Device

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.

Doxorubicin

Drug

Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.

Modified Barium Swallow Impairment Profile (MBSImP)

Other

The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.

Primary outcomes

  1. Percentage of Participants With Local-regional Progression-free Survival

    Time frame: 2 years

    2-year cumulative incidence of locoregional progression/failure with death as a competing risk will be defined as infield progression if included in the RT field and meets one of the following criteria: 25% increase in tumor volume, new lesions, and/or 25% increase in metabolic tumor volume or total lesion glycolysis.

Secondary outcomes

  1. Overall Survival

    Time frame: 2 years

  2. Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities

    Time frame: 2 years

    During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0 Physician-reported acute grade 3 or higher treatment-related toxicities, regardless of attribution.

  3. Rate of Late Dysphagia

    Time frame: 2 years

    Grade 2 or higher late toxicity rate. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0

  4. Rate of Late Xerostomia/Dry Mouth

    Time frame: 2 years

    Rate of late xerostomia/dry mouth. During radiation, adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events-Version 4.0

  5. Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline

    Time frame: 12 months

    Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Jun 20, 2013
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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