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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT and doxorubicin | Experimental | All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local-regional Progression-free Survival | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 2 years | |
| Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Lee, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan Kettering Monmouth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34293201 | Derived | Romesser PB, Sherman EJ, Whiting K, Ho ML, Shaha AR, Sabra MM, Riaz N, Waldenberg TE, Sabol CR, Ganly I, McBride SM, Fagin JA, Zhang Z, Tuttle RM, Wong RJ, Lee NY. Intensity-modulated radiation therapy and doxorubicin in thyroid cancer: A prospective phase 2 trial. Cancer. 2021 Nov 15;127(22):4161-4170. doi: 10.1002/cncr.33804. Epub 2021 Jul 22. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2019 |
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| 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. |
|
| 2 years |
| Rate of Late Dysphagia | 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 | 2 years |
| Rate of Late Xerostomia/Dry Mouth | 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 | 2 years |
| Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study | 12 months |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Rockville Centre | Rockville Centre | New York | 11570 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Local-regional Progression-free Survival | 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. | Posted | Number | percentage of all participants | 2 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Posted | Number | 95% Confidence Interval | percentage of participants alive | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities | 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. | Posted | Number | percentage of participants | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Rate of Late Dysphagia | 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 | Posted | Number | percent of pts experiencing dysphagia | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Rate of Late Xerostomia/Dry Mouth | 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 | Posted | Number | percent of pts experiencing dry mouth | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline | Comparison of significant functional differences 12 months after treatment assessed using standard Modified Barium Swallow Study | Posted | Count of Participants | Participants | 12 months |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 11 | 27 | 3 | 27 | 22 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stoma site infection | Infections and infestations | Systematic Assessment |
| ||
| Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy Lee, MD | Memorial Sloan Kettering Cancer Center | 212-639-3341 | leen2@mskcc.org |
| Sep 26, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D038524 | Diffusion Magnetic Resonance Imaging |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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