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Thyroid CancerPhase 2RAD-THYRNCT02390934

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

A Phase 2 study testing Radium 223 in people with Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Radium 223
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteFrance
Study dates
1 Oct 2014to 2 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Affiliated to a social security regimen ;
  • Patients with histologically confirmed differentiated thyroid cancer (papillary, follicular including Hurthle cell or poorly differentiated) ;
  • Iodine refractory disease defined by the absence of radioiodine uptake in at least one lesion or progression of the disease within 14 months after a radioactive iodine (RAI) treatment or persistent disease after the administration of a cumulative activity of 22GBq I 131 ;
  • Age ≥18 years ;
  • Eastern Cooperative Oncology Group performance status 0-2 ;
  • Life expectancy longer than 3 months ;
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  • Presence of at least one bone metastasis visible on CT scan or axial skeleton (AS) MRI and not requiring urgent locoregional treatment ;
  • Presence of at least one bone metastasis with uptake on FDG PET/CT ;
  • Presence of at least one bone metastasis with increased uptake on 99mTc HMDP bone scintigraphy or FNa PET/CT
  • Low likelihood of an indication for systemic treatment within the next 6 months, as defined by the absence of soft tissue distant metastases or by the presence of only small (<1cm) soft-tissue metastases, or larger (>1 cm) but stable soft tissue metastases within 6 months prior to inclusion in the present protocol ;
  • Adequate haematological (neutrophils ≥1,5×109/L; platelets ≥100×109/ L; haemoglobin > 9g/dL), renal (creatinine <1,5×upper limit of normal range), and hepatic (total bilirubin < 1.5 institutional upper limit of normal), aspartate aminotransferase and alanine aminotransferase <2,5×upper limit of normal range in the absence of liver metastases or <5×upper limit of normal range in case of liver metastases) functions ;
  • Patients receiving bisphosphonates or anti-RANK ligand (Denosumab) are allowed but patients should have received at least 2 administrations prior to Radium-223 administration and these treatments will be continued during Radium-223 treatment ;
  • Blood negative pregnancy test in women of childbearing potential within 30 days prior to treatment initiation. Both men and women (of childbearing potential) who are sexually active must use adequate contraception during and for at least 6 months post-treatment ;
  • Patient who is fully informed, able to comply with the protocol and who signed the informed consent.

Who cannot join

  • Patients with another malignancy that is not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer) ;
  • Treatment with any investigational drug or with a TKI within the previous 4 weeks, or planned during the treatment period ;
  • Treatment with cytotoxic chemotherapy within the previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks before the study initiation ;
  • Previous systemic therapy with radionuclides, including strontium-89, samarium-153, rhenium-186, rhenium-188 or radium-223 ;
  • Patients with imminent or established spinal cord compression based on clinical findings and/or MRI and/or immediate need for local radiotherapy ;
  • Patients with progressive visceral metastases according to RECIST 1.1 criteria assessed by CT scan and/or symptomatic brain metastases within 6 months prior to study initiation ;
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  • Patient already included in other clinical trial ;
  • Pregnant or breast feeding women ;
  • Fecal or urinary unmanageable incontinence ;
  • Bone marrow dysplasia, uncontrolled diabetes or infection, NYHA Class III or IV cardiac disorders, fecal incontinence and symptomatic intestinal disease (such as Crohn disease or ulcerative colitis).

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

About this study

Official title: Single Arm Phase II Trial Evaluating the Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer

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.

Conditions
Thyroid Cancer
Being tested
Radium 223
Keywords
Radium 223, bone metastases
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium 223Radiation

    Also called Xofigo

Study groups in NCT02390934
Study groupRoleWhat they receive
Radium 223ExperimentalRadium-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.
Receives: Radiation: Radium 223

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic response (PERCIST criteria)

    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

    Measured: Assessed 1 months after 3 monthly injections of Radium 223

Secondary outcomes (6)

  1. Pain response (numerical rating scale)

    evaluated on a 0-to-10 numerical rating scale completed by the patients

    Measured: Assessed every 30 days following the first Radium 223 up to 7 months

  2. Partial pain response (improvement ≥30% and <50% pain score)

    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

    Measured: Assessed every 30 days following the first Radium 223 up to 7 months

  3. ECOG performance status

    Measured: Assessed every 30 days following the first Radium 223 up to 7 months

  4. Changes in Quality of life (QLQ-C30 and QLQ-BM22 questionnaires)

    evaluated with the QLQ-C30 and QLQ-BM22 questionnaires

    Measured: Assessed every 30 days following the first Radium 223 up to 7 months

  5. Time to occurrence of first skeletal-related events

    ) 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.

    Measured: Assessed every 30 days following the first Radium 223 up to 7 months

  6. Overall survival

    Measured: Assessed every 30 days following the first Radium 223 up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study start1 Oct 2014
  3. Primary completion2 Apr 2019
  4. Study completion2 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390934
Sponsor's protocol ID
2014-001070-34
Other IDs
2014/2110, 2014
Acronym
RAD-THYR
Status last verified
Jun 2019
First submitted
1 Oct 2014
Last updated
11 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • Deandreis D, Maillard A, Zerdoud S, Bournaud C, Vija L, Sajous C, Terroir M, Leenhardt L, Schlumberger M, Borget I, Leboulleux S. 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. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3238-3249. doi: 10.1007/s00259-021-05229-y. Epub 2021 Feb 23.

    PubMed 33619600

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium 223 in people with Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic response (PERCIST criteria) (time frame: Assessed 1 months after 3 monthly injections of Radium 223). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.

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