Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Hyperparathyroidism

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Parathyroid Diseases

Primary Hyperparathyroidism

Parathyroid Carcinoma

All Drugs and Chemicals

Bone Density Conservation Agents

Parathyroid Hormone

Hormones

Calcium

Calcium, Dietary

All adult (18 years old and older) patients registered in EUROCRINE® database that underwent surgery for primary hyperparathyroidism and received histopathologic diagnosis of parathyroid carcinoma from 2015 till 2021 will be included

Radical treatment of suspected parathyroid carcinoma should consist of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and central lymph node dissection.

Surgical treatment of parathyroid carcinoma

Francesco Pennestrì, Dr

Marco Raffaelli, Prof

The main aim of the study is to evaluate the incidence of post-operative diagnosis of PC and atypical parathyroid neoplasm in patients who underwent surgery for pHPT in different European centers using the EUROCRINE® database. Moreover, we aim to evaluate the peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in these patients category.

Parathyroid cancer (PC) is one of the rarest malignancies (0.005% of all tumours) and it represents less than 1% of all the causes of primary hyperparathyroidism (pHPT).

It is frequently a sporadic disease, but it can be part of hereditary syndromes (i.e. HPT- JT, MEN, MEN2A and FIHP).

Clinical and biochemical presentation is usually more severe comparing to other forms of primary hyperparathyroidism as it is often associated to very high serum-calcium and PTH levels and target organs' damages.

Malignancy should be suspected on the basis of the aforementioned biochemical data and the imaging evidences (such as parathyroid lesion dimension \>3 cm, faded edges, inhomogeneous internal features and cervical lymph nodes enlargement).

In case of suspected PC a radical treatment should be proposed to the patient, consisting of parathyroidectomy and en bloc ipsilateral hemithyroidectomy and ipsilateral central neck dissection. Indeed, the oncological radicality during surgical treatment is mandatory, as effective adjuvant therapy is not available.

However, pre-operative differential diagnosis with parathyroid adenoma is still challenging, thus malignancy can be detected only after the histological analysis of the specimen and sometimes after recurrences.

Moreover, parathyroid atypical adenoma entity is still controversial, as it presents suspicious histological features, but certain signs of malignancy are lacking (such as capsular, vessels and neural invasion). Furthermore, natural history and biological behaviour are still unknown.

European Multicentric Study on Parathyroid Carcinoma

Reasonable requests will be evaluated by the Eurocrine Council

Descriptive analysis of the exact incidence of parathyroid carcinoma among patients undergoing surgical treatment of primary hyperparathyroidism in European centers.

Descriptive analysis of operative and oncologic outcome of patients undergoing surgical treatment of primary hyperparathyroidism and receiving pathological report od parathyroid carcinoma in European centers.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Nutritional and Metabolic Diseases

Hypercalcemia

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

KHK7580

To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy

Kyowa Kirin Co., Ltd.

KHK7580 was orally administered daily for up to week 52.

KHK7580 (2-24 mg)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

serum corrected Ca conc.

serum intact Parathyroid Hormone conc.

parathyroid carcinoma

Unable to undergo parathyroidectomy

Relapse after parathyroidectomy

previous cinacalcet use

Pharmacotherapy for primary diseases

parathyroidectomy

Parathyroid intervention therapy

Research & Development Planning Department, Research & Development Division

The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.

The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.

Serum Corrected Ca Level

Serum Intact Parathyroid Hormone Level

Serum Whole Parathyroid Hormone Level

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Small Cell Lung Carcinoma

Melanoma

Sarcoma

Carcinoma, Small Cell

Lung Neoplasms

Carcinoid Tumor

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Connective and Soft Tissue

Adenocarcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Bortezomib

Dacarbazine

Antineoplastic Agents, Alkylating

Alkylating Agents

Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2

Dacarbazine and bortezomib

Andrew Poklepovic, MD

Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.

The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.

Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Virginia Commonwealth University

Cinacalcet

Hormone Antagonists

Cinacalcet HCl

This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).

An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
European Multicentric Study on Parathyroid Carcinoma	NCT05789680	Parathyroid Car...	Surgical treatm...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism	NCT03280264	Parathyroid Car... Primary Hyperpa...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma	NCT00580320	Melanoma Soft Tissue Sar... Parathyroid Car... Small Cell Carc... Carcinoid Tumor...	Dacarbazine and...	18 Years -	Virginia Commonwealth University
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism	NCT01460030	Parathyroid Car... Hypercalcemia Primary Hyperpa...	Cinacalcet HCl	20 Years -	Kyowa Kirin Co., Ltd.
European Multicentric Study on Parathyroid Carcinoma	NCT05789680	Parathyroid Car...	Surgical treatm...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism	NCT01460030	Parathyroid Car... Hypercalcemia Primary Hyperpa...	Cinacalcet HCl	20 Years -	Kyowa Kirin Co., Ltd.
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma	NCT00580320	Melanoma Soft Tissue Sar... Parathyroid Car... Small Cell Carc... Carcinoid Tumor...	Dacarbazine and...	18 Years -	Virginia Commonwealth University
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism	NCT03280264	Parathyroid Car... Primary Hyperpa...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for parathyroid carcinoma