Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Adenocarcinoma, Follicular

Adenocarcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Papillary Thyroid Carcinoma

Thyroid Cancer, Medullary

Thyroid Cancer, Follicular

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Vasodilator Agents

Amino Acids

Lenvatinib

Tyrosine Kinase Inhibitors

Calcitonin

Salmon calcitonin

Calcitonin Gene-Related Peptide

Katacalcin

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.

SOC followed by Adaptive Care TKI Therapy for DTC Participants with \>=50% drop: Lenvatinib + Sorafenib.

Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.

SOC followed by Adaptive Care TKI Therapy for MTC Participants with \>=50% drop: Cabozantinib + Vandetanib.

Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Cabozantinib

Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Vandetanib

Christine H. Chung, M.D.

Participants will have been diagnosed with advanced progressive thyroid cancer and are about to start treatment with a tyrosine kinase inhibitor (TKI).

The purpose of this study is to evaluate the efficacy and tolerability of tyrosine kinase inhibitor therapy (Lenvatinib or Sorafenib for differentiated thyroid cancer \[which includes papillary thyroid cancer, follicular thyroid cancer, and poorly differentiated thyroid cancer\]; and Cabozantinib or Vandetanib for medullary thyroid cancer) through adaptive (intermittent) versus conventional (continuous) regimen.

Population: Patients with advanced progressive 131I-refractory DTC or MTC will be enrolled to this study. Forty-five patients responding to TKI therapy (defined as 50% drop in tumor marker level within the first two months of treatment) will be randomized to receive TKI therapy either through adaptive (intermittent) or conventional (continuous) regimen.

Researchers consenting the patients will become unblinded upon treatment assignment.

Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer

Adaptive Tyrosine Kinase Inhibitor Therapy In Patients With Advanced Progressive Thyroid Cancer

Median time-to-discontinuation (TTD) of treatment per study arm, due to Progressive Disease.

Median time-to-discontinuation (TTD) of treatment per study arm, due to Intolerability.

Median time-to-discontinuation (TTD) of treatment per study arm, due to Disease-related death at 2 years.

The response rate will be estimated using binomial theory with Wilson's method for the 95% confidence interval. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter (LD). Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

The median progression-free survival rates will be estimated from the Kaplan-Meier curve with the 95% confidence interval obtained from Greenwood's formula. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

The median overall survival rates will be estimated from the Kaplan-Meier curve with the 95% confidence interval obtained from Greenwood's formula.

H. Lee Moffitt Cancer Center and Research Institute

Standard of Care (SOC) TKI Therapy for Differentiated Thyroid Cancer (DTC): Lenvatinib + Sorafenib.

Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Standard of Care: DTC

SOC followed by Adaptive Care TKI Therapy for DTC Participants with \>=50% drop: Lenvatinib + Sorafenib.

Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Adaptive Care: DTC

Standard of Care (SOC) TKI Therapy for Medullary Thyroid Cancer: Cabozantinib + Vandetanib.

Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Standard of Care: MTC

SOC followed by Adaptive Care TKI Therapy for MTC Participants with \>=50% drop: Cabozantinib + Vandetanib.

Cabozantinib: Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Vandetanib: Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.

Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.

Adaptive Care: MTC

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Christine Chung, MD

Data not collected. Only 3 participants remained on study treatment, and none for full length of trial.

Time to Tyrosine Kinase Inhibitor (TKI) Treatment Discontinuation Due to Progressive Disease

Time to Tyrosine Kinase Inhibitor (TKI) Treatment Discontinuation Due to Intolerability

Time to Tyrosine Kinase Inhibitor (TKI) Treatment Discontinuation Due to Disease Related Death

Overall Response Rate (ORR)

Progression-free Survival (PFS)

Overall Survival (OS)

Overall Study

The Shared-care Group will comprise of patients who are receiving long term follow-up care for their condition by their PCP.

The Control Group will be made of patients who are receiving long term follow-up care for their condition of low-risk DTC at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC).

A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).

Shared-care model

Syed A. Imran, Dr.

Glenda Mccarthy

This study aims to assess the feasibility of a shared-care model for low-risk differentiated thyroid cancer (DTC) patients, primary care practitioners (PCPs) and the tertiary care center utilizing a digital health-based thyroid cancer assessment reminder system (TCARS) in Medable with an expedited referral to specialists for rapid assessment in case of a concern of recurrence.

Low risk differentiated thyroid cancer (DTC) is being increasingly diagnosed and although its overall survival is excellent, lifelong follow-up is needed due to the risk of ongoing health challenges and the cancer recurring. While it is not feasible to follow this growing number of patients in specialist centers due to limited resources, recent studies have suggested that simply discharging them to their PCP is not ideal because many PCPs do not feel confident in managing various aspects of DTC. More importantly, a large number of patients in Nova Scotia do not have regular access to PCPs and are thus followed by walk-in clinics or nurse practitioners.The optimal approach would therefore be, to establish a shared care follow-up model including participation from patients, primary care practitioners (PCPs) and specialists.

In this study, the feasibility of a shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system will be tested. This strategy will be compared to standard specialist only follow-up. The study population comprises 60 low risk adult DTC patients who will be randomly allocated to either Shared-care or Control group on a 1:1 basis (30 patients each).

The main objectives of this study is to:

1. Develop a digital health-based thyroid cancer assessment reminder system alerting patients and PCPs of patients' forthcoming appointment and guidelines.
2. Establish an expedited referral pathway to tertiary care for rapid assessment of patients discharged to PCPs in case of a risk of recurrence.
3. Identify the feasibility of the Shared-care model.
4. Compare the completion of the clinical assessments between Shared-care and Control Groups.
5. Compare patient and provider satisfaction and acceptability between Shared-care and Control Groups.
6. Compare PCP confidence in dealing with DTC before and after study completion.

Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.

Feedback on the use of the Medable (DCT) system will be assessed using qualitative data gathered through patient and PCP surveys. Some responses will be on a 5-point Likert-type scale from strongly disagree to strongly agree or very unlikely to likely. Other questions will be in a multiple choice format. An open dialogue box will appear at the end of the survey for respondents to enter additional comments.

These outcomes will assess the feasibility of the pilot study. These include:

* Number (%) of eligible patients who are approached for the study and agree to participate in either group.
* Number (%) of eligible patients who are are approached for the study but refuse to participate in either group and reason for refusal.
* Number (%) of patients who remain in the shared-care group at study end.
* Number of patients who choose to terminate the study in either group and reason for termination.
* Number of patients who lost their PCP and returned to specialist care.

These outcomes will be measured to compare shared-care vs control DTC patients during the study duration and prospectively entered into a computerized DTC outcome registry of all study patients to follow their progress. This will be separate from TCARS, which will contain no clinical information.This information will be entered by the study coordinator. These include:

* Number (%) of patients having annual TG/anti-TG AB.
* Number (%) of patients having annual neck ultrasound.
* Number (%) of patients with TSH test every 6 months.
* Number (%) of patients with TSH within target range and if outside target, whether thyroxine dose was adjusted and TSH rechecked.
* Number (%) of patients with abnormal findings on neck ultrasound or TG/anti-TG AB test.
* Number (%) of patients who were referred back to ITOC using the expedited referral sheet and reason for referral.

Patient satisfaction will be assessed in both groups using the Patient Satisfaction Questionnaire Short form (PSQ -18). The PSQ-18 is a Likert scale questionnaire, consisting of 18 items tapping each of the seven dimensions of satisfaction with medical care. These are 1) general satisfaction, 2) technical quality, 3) interpersonal manner, 4) communication, 5) financial aspects, 6) time spent with doctor, and 7) accessibility and convenience.

Patient and provider satisfaction, acceptability and experience will be assessed through qualitative data gathered by provider (Specialist and PCP) interviews (n=8) and patient focus groups (n=12-16; 2 groups of 6-8 participants each).

PCP involvement and confidence in DTC management outcomes will be based on previously published surveys.

The survey is based on the National Cancer Institute Survey of Physician Attitudes Regarding the Care of Cancer Survivors which was modified for thyroid cancer. In addition to the standard survey items, PCPs will be asked to report how confident they are in discussing key aspects of follow-up care with thyroid cancer survivors including:

* Role of serum hsTG and anti-TG AB in long term surveillance.
* Role of neck US in long term surveillance.
* When to end long term surveillance.
* When to refer back to specialist. All responses will be on a 5-point Likert type not at all confident to very confident.

Syed Ali Imran

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Gastrointestinal Agents

Denosumab

Sorbitol

Dosage: 120 mg, monthly for total of 6 months, then every 12 weeks for 2 doses, for a total treatment course of one year

Route of administration: subcutaneous injection

Formulation of Dosage forms

The vial presentations of denosumab contain 60 mg/mL denosumab, 17 mM sodium acetate, and 4.7% (w/v) sorbitol, at a pH of 5.2, filled to a target deliverable volume of 1.0 mL; or 70 mg/mL denosumab, 18 mM sodium acetate and 4.6% (w/v) sorbitol, at a pH of 5.2, filled to a target deliverable volume of 1.7 mL. The prefilled syringe (PFS) drug product contains denosumab at 60 mg/mL, 17 mM sodium acetate, 4.7% (w/v) sorbitol, and 0.01% (w/v) polysorbate 20, at a pH of 5.2, filled to a target deliverable volume of 1.0 mL.

Dosage: 120 mg, monthly for total of 6 months, then every 12 weeks for 2 doses, for a total treatment course of one year

Route of administration: subcutaneous injection

Hope Rugo, MD

The purpose of this study is to see whether taking denosumab for 12 months in women with a significant number of disseminated tumor cells in the bone marrow can reduce the number of these cells below a significant level.

The presence of disseminated tumor cells (DTC) in the bone marrow in women with early stage breast cancer is an important prognostic factor associated with an increase in both recurrence and disease-associated death. In a pooled analysis of 4703 invasive breast cancer patients, detection of DTC in the bone marrow was associated with an increase in disease recurrence, distant metastases, and death from breast cancer over a median follow-up period of 5.2 years. Subsequent studies have demonstrated that the presence of DTC in the bone marrow of women with early breast cancer following completion of adjuvant therapy have an even greater impact on the risk of recurrence and death from breast cancer. Multivariate analysis demonstrated that the presence of marrow cells was an independent prognostic factor for reduced breast cancer specific survival with a relative risk of 6.3 (2.3-17.6, p\<0.0001). Clearly, the detection of DTC in women with early stage breast cancer is a marker for increased risk of relapse and death, and this could serve as a unique indicator to select higher risk patients for intervention with targeted therapeutics.

It has long been recognized that there is close relationship between bone and immune system, recent studies also suggests that in addition to monocytes/macrophage, T cells (especially Th17, a subset of T helper cells that produces IL-17), B cells and dendritic cells all play an important role in osteoclast formation. RANKL, in addition to its effect on osteoclasts, also induces local inflammation. Several recent studies have demonstrated that the presence of tumor associate macrophages (TAM) is associated with more aggressive disease, and a worse outcome. Preclinical data suggests that TAM plays an important role in promoting metastases and resistance to therapy. In addition to RANKL, there are other genes secreted by breast cancer cells, including TGF-β, TNF associated factor 6 (TRAF6), Hypoxia Induced Factor -1 (HIF-1) and Bone morphogenetic protein 2 (BMP2), also involve in bone-cancer "vicious cycle" and induce RANKL expression. Cytokines, such as IL-4, IL-6, IL-17, TNF-α and CSF-1, also play an important role in osteolysis and immune response in bone microenvironment by regulating TAM function (CSF-1, IL-4 and IL-17) and RANKL expression. Recently, CD47 and Signal Regulatory Protein α (SIRPA) were also shown to impair macrophage function, and associated with increased risk for recurrence in patients with breast cancer. The investigators hypothesize that patients with higher DTC may have higher expression of RANKL and chronic inflammatory cytokines. The investigators plan to evaluate the expression of RANK, RANKL, TRAF6, BMP2, CSF-1, CD47, IL-17 and SIRPA on isolated DTC and bone marrow hematopoietic cells, and correlate these results to the outcome of patients enrolled in the trial.

The investigators hypothesize that treatment with denosumab will decrease the number of DTC in women with early stage breast cancer who have completed adjuvant or neoadjuvant cytotoxic therapy possibly by preventing cancer cell migration, and by promoting cancer cell death by changing the bone into a "hostile" environment .

The investigators propose to conduct a non-randomized phase II trial testing this hypothesis in women with early stage breast cancer and persistent DTC following adjuvant systemic therapy. Patients with DTC will receive denosumab monthly for 6 months, then every 3 months for a total of one-year treatment, to mirror the schedule utilized in the ongoing randomized phase III denosumab versus placebo D-CARE trial. DTC will be monitored following 6 months and 12 months of therapy. The investigators anticipate that this treatment will reverse the "vicious cycle" between bone and cancer cells.

Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer

Reduction of disseminated tumor cells (DTC)/ mililitre (ml) from \>10DTC/ml to ≤ 10DTC/ml. DTC measured by IE/FC in patients with early stage

Changes from baseline in disseminated tumor cell counts

Correlate breast cancer recurrence risk with individual values for DTC at each time point

University of California, San Francisco

Amgen

Clinical professor

Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.

Treatment

Age, Continuous

Study terminated early due to low accrual

Low accrual resulted in insufficient data to power statistical analyses for this outcome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer	NCT03630120	Thyroid Cancer Thyroid Cancer,... Differentiated ... Papillary Thyro... Follicular Thyr... Poorly Differen...	Lenvatinib Sorafenib Cabozantinib Vandetanib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.	NCT05510934	Low Risk Differ...	Shared-care mod...	18 Years -	Nova Scotia Health Authority
Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer	NCT01545648	Early Stage Bre...	Denosumab	18 Years -	University of California, San Francisco
Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer	NCT01545648	Early Stage Bre...	Denosumab	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for dtc

Every month we try and update this database with for dtc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dtc

Every month we try and update this database with for dtc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dtc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.