Clinical trial NCT01882816: Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
Official title: A Phase II Study of Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Non-Anaplastic Non-Medullary Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: non-anaplastic
non-medullary
radiation
IMRT
Doxorubicin
13-070
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Local-regional Progression-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Percentage of Participants With Grade 3 or Higher Treatment-related Toxicities
timeFrame: 2 years
measure: Rate of Late Dysphagia
timeFrame: 2 years
measure: Rate of Late Xerostomia/Dry Mouth
timeFrame: 2 years
measure: Number of Participants With Significant Functional Difference in Dysphagia at 12 Months Compared to Baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.