Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer (NCT NCT01882816)

Last Updated: 2022-12-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

2 years

Results posted on

2022-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	IMRT and Doxorubicin All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Age, Continuous	45.6 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Percentage of Participants With Local-regional Progression-free Survival	15.2 percentage of all participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Overall Survival	77.3 percentage of participants alive Interval 62.8 to 95.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities	33.4 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Rate of Late Dysphagia	8.0 percent of pts experiencing dysphagia

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Rate of Late Xerostomia/Dry Mouth	4.0 percent of pts experiencing dry mouth

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	IMRT and Doxorubicin n=27 Participants All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline Participants with significant functional difference as compared to baseline	0 Participants
Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline Participants without significant functional difference as compared to baseline	27 Participants

Adverse Events

IMRT and Doxorubicin

Serious events: 3 serious events

Other events: 22 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	IMRT and Doxorubicin n=27 participants at risk All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Infections and infestations Stoma site infection	3.7% 1/27 • 2 years
Respiratory, thoracic and mediastinal disorders Stridor	11.1% 3/27 • 2 years

Other adverse events

Other adverse events
Measure	IMRT and Doxorubicin n=27 participants at risk All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. IMRT: 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: 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: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly. Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Blood and lymphatic system disorders Anemia	14.8% 4/27 • 2 years
Metabolism and nutrition disorders Hyperglycemia	14.8% 4/27 • 2 years
Metabolism and nutrition disorders Hypocalcemia	11.1% 3/27 • 2 years
Investigations Lymphocyte count decreased	81.5% 22/27 • 2 years
Investigations Neutrophil count decreased	14.8% 4/27 • 2 years
Investigations Platelet count decreased	11.1% 3/27 • 2 years
Investigations White blood cell decreased	14.8% 4/27 • 2 years

Additional Information

Dr. Nancy Lee, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-3341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place