Page 12 - Delaware Medical Journal - February 2016
P. 12
CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
RTOG 0912: A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMR), Paclitaxel and Pazopanib (NSC 737754)/ Placebo, for the Treatment of Anaplastic Thyroid Cancer
The objectives of the trial are: Primary Objective:
To evaluate and compare overall survival at 1 year from study registration.
Secondary Objectives:
1. To evaluate local-regional control at 6 and 12 months.
2. To evaluate the rate of grade 4 (CTCAE, v. 4.0) hemorrhage, grade 4 febrile neutropenia, or any Grade 5 adverse
of the protocol regimen.
3.
related to the induction or concurrent treatment components of the protocol regimen.
4. To evaluate the rate of treatment discontinuation due to toxicity during the induction or concurrent treatment
components of the protocol regimen.
5. To evaluate response (as per RECIST) of the primary site following the treatment component in subjects with
measurable disease prior to chemoradiation.
Eligibilty:
Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer. If there was a total or partial thyroidectomy completed within 3 months of enrollment, the surgical specimen must show the area of anaplastic thyroid cancer to be at least 1 cm in greatest dimension.
Zubrod Performance Status 0-2.
Adequate organ function (hematologic, hepatic, renal).
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation
No prior systemic chemotherapy for anaplastic thyroid cancer within 4 weeks of registration.
No known brain metastasis .
Treatment:
7 days a week for 2-3 weeks
Then
IMRT 66Gy in 33 fractions over 6-7 weeks, M-F,
and
and
7 days a week, for 6-7 weeks or until the end of radiation
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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Del Med J
| February 2016
| Vol. 88
| No. 2
