NCT02390934: RAD-THYR

Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer

Completed Phase 2 Last updated 11 June 2019

What this trial tests

Phase 2 trial testing Radium 223 in Thyroid Cancer in 13 participants. Completed in 2 April 2019.

Timeline

1 October 2014

Primary endpoint
2 April 2019

2 April 2019

Quick facts

Lead sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 October 2014
Primary completion	2 April 2019
Estimated completion	2 April 2019
Sites	1 location across France

Drugs / interventions tested

• Radium 223

Conditions studied

• Thyroid Cancer — all drugs for Thyroid Cancer →

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, any sex, with Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 \[23\]. 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 \[24\] \[25\]. Preliminary results show some interest of using this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer \[26\]. 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) \[27\].

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metastatic bone disease: Pathogenesis and therapeutic options: Up-date on bone metastasis management.
   D'Oronzo S, Coleman R, Brown J, Silvestris F. · · 2019 · cited 201× · PMID 30937279 · DOI 10.1016/j.jbo.2018.10.004
2. Current concepts in bone metastasis, contemporary therapeutic strategies and ongoing clinical trials.
   Gdowski AS, Ranjan A, Vishwanatha JK. · · 2017 · cited 83× · PMID 28800754 · DOI 10.1186/s13046-017-0578-1
3. Bone metastases in thyroid cancer.
   Iñiguez-Ariza NM, Bible KC, Clarke BL. · · 2020 · cited 63× · PMID 32154098 · DOI 10.1016/j.jbo.2020.100282
4. Radium-223 Therapy for Patients with Metastatic Castrate-Resistant Prostate Cancer: An Update on Literature with Case Presentation.
   Nguyen NC, Shah M, Appleman LJ, Parikh R, et al · · 2016 · cited 16× · PMID 27774318 · DOI 10.1155/2016/2568031
5. RADTHYR: an open-label, single-arm, prospective multicenter phase II trial of Radium-223 for the treatment of bone metastases from radioactive iodine refractory differentiated thyroid cancer.
   Deandreis D, Deandreis D, Maillard A, Zerdoud S, et al · · 2021 · cited 9× · PMID 33619600 · DOI 10.1007/s00259-021-05229-y
6. Ra223 in Bone Metastases with Osteolytic Activity.
   Costa RP, Cardile D, Murabito A, Tripoli V, et al · · 2018 · cited 1× · PMID 29719487 · DOI 10.4103/wjnm.wjnm_22_17