Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer (RAD-THYR)
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|ClinicalTrials.gov Identifier: NCT02390934|
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : May 16, 2017
The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on the results of the phase III trial, the protocol using an injection of Radium-223 activity of 50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this study will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e. at 3 months after the first injection. If disease progression at that time is excluded, patients will be treated with 3 further injections for a total of 6 administrations of Radium-223. The principal response criterion at 3 and 6 months will be the metabolic response on FDG PET/CT, but other imaging techniques will also be performed: axial skeleton MRI, 99mTc-HMDP bone scan and FNa PET/CT. Axial skeleton MRI is the reference for soft tissue study. 99mTc- HMDP bone scan is the most used and available routine tool to detect bone metastases in cancer patients, but its sensitivity in patients with bone metastases from thyroid cancer is low, because most lesions are lytic . 18FNa PET/CT shows higher sensitivity than 99mTc-HMDP bone scan to detect bone lesions in cancer patients and is able to detect micrometastases that are not seen on bone scan  . Preliminary results show some interest of using this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer . Furthermore preliminary data show that FNa PET/CT can be useful to quantify response to Radium-223 in prostate cancer. In only five patients evaluated by FNa PET/CT at baseline, 6 weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative analysis by SUV max showed a relationship between PSA and SUV max level decrease in 3 patients (-44%, -31%, -27% vs -52%, -75, and -49% respectively) .
Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are frequently submitted to local treatment modalities, and this may induce fibrosis and recalcification. Therefore, already treated metastases and not treated metastases will be studied separately as two separate subgroups of target lesions.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Radiation: Radium 223||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm Phase II Trial Evaluating the Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Radium 223
Radium-223 (Xofigo®) will be supplied in vials as a ready-to-use solution for intravenous administration. The activity (administered radioactivity) will be 50 kBq/kg b.w., and multiple treatment activities up to 6 injections will be administered at intervals of 4 weeks.
Radiation: Radium 223
Other Name: Xofigo
- Metabolic response (PERCIST criteria) [ Time Frame: Assessed 1 months after 3 monthly injections of Radium 223 ]Metabolic response according to PERCIST criteria in up to five lesions on FDG PET/CT performed 1 month after 3 monthly injections of Radium 223
- Pain response (numerical rating scale) [ Time Frame: Assessed every 30 days following the first Radium 223 up to 7 months ]evaluated on a 0-to-10 numerical rating scale completed by the patients
- Partial pain response (improvement ≥30% and <50% pain score) [ Time Frame: Assessed every 30 days following the first Radium 223 up to 7 months ]Partial pain response is defined as an improvement ≥30% and <50% of the worst pain compared to score at baseline. Complete pain response is defined as an improvement ≥50% of the worst pain score compared to score at baseline
- ECOG performance status [ Time Frame: Assessed every 30 days following the first Radium 223 up to 7 months ]
- Changes in Quality of life (QLQ-C30 and QLQ-BM22 questionnaires) [ Time Frame: Assessed every 30 days following the first Radium 223 up to 7 months ]evaluated with the QLQ-C30 and QLQ-BM22 questionnaires
- Time to occurrence of first skeletal-related events [ Time Frame: Assessed every 30 days following the first Radium 223 up to 7 months ]) confirmed by imaging defined as: (i) local progression with indication for local treatment such as surgery, thermoablation, cement injection, external beam radiation, or (ii) pathological fracture, spinal cord compression (iii) appearance of new bone lesions.
- Overall survival [ Time Frame: Assessed every 30 days following the first Radium 223 up to 7 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390934
|Contact: Sophie LEBOULLEUX, MD||0142116365 ext +email@example.com|
|Contact: Isabelle BORGET, MD||0142114146 ext +firstname.lastname@example.org|
|Villejuif, Val de Marne, France, 94805|
|Contact: Sophie LEBOULLEUX, MD 0142116365 ext +33 email@example.com|
|Contact: Isabelle BORGET, MD 0142114146 ext +33 firstname.lastname@example.org|
|Principal Investigator: Sophie LEBOULLEUX, MD|
|Principal Investigator:||Sophie LEBOULLEUX, MD||Gustave Roussy, Cancer Campus, Grand Paris|