Neoplasms

All Conditions

Blood and Lymph Conditions

Rare Diseases

Carcinoma

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Thymic Epithelial Tumor

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Cisplatin

Etoposide phosphate

The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w\*4.

concurrent chemoradiation

Kailiang Wu, M.D.,Ph.D

This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Intensity modulated radiotherapy with VP-16/Cisplatin

Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria

from registration to death as a result of any cause.

from registration to first documentation of disease progression or death.

Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0

Fudan University

professor

Symptoms and General Pathology

Recurrence

Docetaxel

Nedaplatin

HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.

All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .

Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Thymosin a1

HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.

hypofractionated radiotherapy

All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .

concurrent chemoradiotherapy

Hui Liu, Professor

This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).

Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study

EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire

Sun Yat-sen University

Professor

Neoplasms, Glandular and Epithelial

Anti-Inflammatory Agents

Gastrointestinal Agents

Prednisone

Octreotide

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

octreotide acetate

prednisone

David S. Ettinger, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to compare the effectiveness of octreotide alone or with prednisone in treating patients with metastatic or recurrent thymoma.

OBJECTIVES: I. Determine the objective response rate in patients with metastatic or recurrent thymoma treated with octreotide. II. Determine the duration of remission in these patients. III. Determine the toxicity of the octreotide regimen in this population. IV. Determine the response rate, duration of remission, survival and toxicity of prednisone added to octreotide in patients with stable disease following octreotide alone.

OUTLINE: All patients receive octreotide subcutaneously three times daily for 1 month. After two courses of treatment, patients are assessed for response. Patients experiencing partial or complete response continue octreotide for a maximum of 1 year (12 courses) in the absence of unacceptable toxicity or disease progression. Patients with stable disease after 2 courses of octreotide receive daily oral prednisone in addition to octreotide for an additional 2 courses. These patients are then reevaluated and continue on octreotide plus prednisone for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 4 months for the second year, every 6 months for the next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: There will be 38 patients accrued into this study over approximately 2 years.

Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma

Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Group Chair

Patients diagnosed with the following TET subtypes:

* Thymoma Type A
* Thymoma Type AB
* Thymoma Type B1
* Thymoma Type B2
* Thymoma Type B3
* Thymic Carcinoma

Patients with thymic epithelial tumors who have experienced recurrence.

AI Diagnostics uses advanced algorithms for precise histological image analysis to help diagnose disease, including subtype.

Artificial Intelligence Diagnostics

This AI tool evaluates thymic tumour data and other clinical data and calculates the risk of recurrence, with the aim of analysing whether there is an association with specific subtypes of thymic epithelial tumours and clinical data.

Recurrence Prediction Tool

Anna Salut Esteve Domínguez

Thymic epithelial tumors are rare neoplasms in the anterior mediastinum. The cornerstone of the treatment is surgical resection. Administration of postoperative radiotherapy is usually indicated in patients with more extensive local disease, incomplete resection and/or more aggressive subtypes, defined by the WHO histopathological classification.

In this classification thymoma types A, AB, B1, B2, B3, and thymic carcinoma are distinguished. Studies have shown large discordances between pathologists in subtyping these tumors. Moreover, the WHO classification alone does not accurately predict the risk of recurrence, as within subtypes patients have divergent prognoses.

The investigators will develop AI models using digital pathology and relevant clinical variables to improve the accuracy of histopathological classification of thymic epithelial tumors, and to better predict the risk of recurrence.

In this multicentric and international project three existing databases will be used from Rotterdam, Maastricht and Lyon. For all models one database will be used to build AI models, and the other two for external validation.

The ultimate goal of this project is to develop AI models that support the pathologist in correctly subtyping thymic epithelial tumors, in order to prevent patients from under- or overtreatment with adjuvant radiotherapy.

Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors

Artificial Intelligence for Histopathological Classification and Recurrence Prediction of Thymic Epithelial Tumors

AI-models 1-3 will be built and validated on the EMC-database, while AI-model 4 will be built on the MUMC+-database and validated on both. Model performance will be assessed using sensitivity, specificity, negative/positive predictive value. Decision analysis curves will quantify the clinical benefit, identifying patient groups with the largest utility.

The EMC-dataset includes 179 TET-patients classified by experienced TET-pathologists. Cases with good agreement between pathologists will be used for training AI-models. Evaluation includes digitized pathology slides assessed by an international expert-panel. The MUMC-database (137 patients) and CHUL-database (181 patients) provide additional data, including clinical variables. Relevant factors include age, gender, tumor volume, stage, completeness of resection, autoimmune disorders, and treatment details.

This outcome aims to create an AI-framework with two principal goals. First, investigate TET-subtypes using four different models emphasizing cell type, morphological structures, and a combination. Second, classify patients based on recurrence outcome within 5 years. An ablation study will be conducted with state-of-the-art deep learning classifiers (ResNet, Inception).

Maastro Clinic, The Netherlands

Hospices Civils de Lyon

Erasmus Medical Center

PhD student

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Small Cell Lung Carcinoma

Mesothelioma

Mesothelioma, Malignant

Carcinoid Tumor

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Small Cell Lung Cancer

Malignant Mesothelioma

radiofrequency ablation

Robert D. Suh, MD

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

OBJECTIVES:

* Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies.
* Determine the efficacy of this treatment, in terms of local control, in these patients.
* Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients.

OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours.

Patients are followed at 1, 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Radiofrequency Ablation of Pulmonary Malignancy

Jonsson Comprehensive Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Prostatic Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

Patients receive a specific print intervention manual entitled Facing Forward Series: Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.

Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.

educational intervention

psychosocial assessment and care

quality-of-life assessment

Suzanne M. Miller, PhD

RATIONALE: Printed educational materials, such as the Facing Forward Series: Life After Cancer Treatment manual, may help make the transition from cancer patient to cancer survivor easier in patients who are finishing treatment for cancer. It is not yet known if the Facing Forward Series: Life After Cancer Treatment manual and The Cancer Information Service, Questions and Answers fact sheet is more effective than the The Cancer Information Service, Questions and Answers fact sheet alone in helping to make life after cancer treatment easier and to improve quality of life in patients with breast cancer, colorectal cancer, prostate cancer, or chest cancer.

PURPOSE: This randomized clinical trial is studying how well printed education materials work in assisting patients who are finishing treatment for stage I, stage II, or stage IIIA breast cancer, colorectal cancer, prostate cancer, or chest cancer to make the transition from cancer patient to cancer survivor easier.

OBJECTIVES:

Primary

* Determine the efficacy of a psychoeducational intervention comprising a specific print intervention manual (Facing Forward Series: Life After Cancer Treatment \[Facing Forward manual\]) and a general print intervention fact sheet (The Cancer Information Service, Questions and Answers) vs the general print intervention fact sheet only on the uptake of recommended actions (e.g., developing a wellness plan after treatment, dealing with pain and fatigue, finding support groups to deal with feelings after treatment, and dealing with family issues after treatment) in patients completing active treatment for stage I-IIIA breast, prostate, colorectal, or thoracic cancer.
* Explore patient process evaluations of the Facing Forward manual in terms of its usability, comprehension, and satisfaction.

Secondary

* Examine psychological outcomes (i.e., depressive symptoms, fear of recurrence, health-related quality of life, and self-efficacy) as a function of exposure to the Facing Forward manual.

OUTLINE: This is a multicenter, randomized, controlled, open-label, cohort study. Patients are stratified according to participating center, prior chemotherapy (yes vs no), and type of cancer (breast vs colorectal vs prostate vs thoracic). Patients are randomized to 1 of 2 arms.

* Arm I (intervention): Patients receive a specific print intervention manual entitled Facing Forward Series: Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.
* Arm II (control): Patients receive the general print intervention fact sheet entitled The Cancer Information Service, Questions and Answers.

In both arms, patients are evaluated at baseline (within 18 days of the patient's final cancer treatment visit), 8 weeks (via mailed home materials), and then at 6 months (via mailed home materials). Baseline evaluations include background information (i.e., demographics and medical status), baseline use of educational materials, survivorship activities, and psychological factors (i.e., depressive symptoms, quality of life, fear of recurrence, and self-efficacy). Psychological factors are also reassessed at 8 weeks and 6 months, as well as use of educational materials and survivorship activities.

For patients in both arms, uptake of recommended actions are reassessed. Patients in arm I complete ratings of the Facing Forward Series: Life After Cancer Treatment manual usability, comprehension, and satisfaction at 8 weeks and 6 months.

PROJECTED ACCRUAL: A total of 332 patients will be accrued for this study.

Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer

Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context: Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment

Fox Chase Cancer Center

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Everolimus will be orally administered at the dosage of 10 mg once daily. Each cycle will be considered as 21 days of treatment. Tumor assessment will be done every two cycles.Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.

Armando Santoro, MD

Given the high expression of IGF-1R and pAKT proteins in thymoma tissues, able to sensitize tumors to mTOR inhibition, and the anticancer activity of the mTOR inhibitors, clinical evaluation in thymoma and thymic carcinoma seems to be very interesting.

Patients will receive continuous treatment with oral everolimus 10 mg once daily.

Efficacy and safety profile of Everolimus will be evaluated.

Patients will receive continuous treatment with oral everolimus 10 mg once daily. Study drug will be self-administered orally (two 5 mg tablets) daily in a fasting state or with a light fat-free meal. Each cycle will be considered as 21 days of treatment; safety was assessed every 21 days. Tumor assessement will be done every two cycles. Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.

Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

Phase II Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD), of Everolimus monotherapy

Progression free survival (PFS) will be evaluated from the date of treatment start until the date of progression or death whichever occurs first, otherwise until the last visit date.

This endpoint is assessed in patients whose best tumor response is CR or PR as the time from the date of the first documentation of confirmed objective tumor response to the date of first documentation of objective tumor progression, objective tumor recurrence, or of death due progressive disease, whichever comes first

Overall Survival (OS) will be evaluated from the date of treatment start until the date of death or last contact for patients alive at the end of the study.

To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging.

Overall safety profile, evaluated on the basis of laboratory and clinical safety parameters

To perform immunohistochemistry for IGF-1R, pAKT ,mTOR, p-S6K, p-S6, p-4E-BP1, and pTEN expression in all pre-treatment tissue specimens of thymoma and thymic carcinoma and correlate with response and survival (PFS and OS).

principal Investigator

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Chemotherapy combined with pembrolizumab.

Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). After 4 cycles treatment, complete response subjects continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, some of partial disease and stable disease subjects can receive surgical treatment. And then continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, other partial disease and stable disease subjects cannot be removed by surgery will continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab for 4 cycles and then pembrolizumab or Normal Saline up to disease progression.

Chemotherapy+Pembrolizumab.

Yongan Zhou

Xunliang Yin

This is an investigational, single arm study.

Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use chemotherapy combined with pembrolizumab to treat thymoma or Thymic carcinoma.

Subjects will be evaluated for eligibility during a 28-day screening period. Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

Up to 40 participants will be enrolled in this study.

Chemotherapy Combined With Pembrolizumab in Treating Patients With Thymoma and Thymic Carcinoma

Single-Arm Study to Carbo-paclitaxel/ Nab-paclitaxel Combined With Pembrolizumab as the First Line Therapy in Treating Patients With Locally Advanced or Metastatic Invasive Thymoma and Thymic Carcinoma That Cannot Be Removed by Surgery

Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors	NCT02636556	Thymoma and Thy...	concurrent chem...	18 Years - 75 Years	Fudan University
Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor	NCT03663764	Thymoma and Thy...	Thymosin a1 hypofractionate... concurrent chem...	18 Years - 70 Years	Sun Yat-sen University
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma	NCT00003283	Thymoma and Thy...	octreotide acet... prednisone	18 Years - 120 Years	Eastern Cooperative Oncology Group
Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors	NCT06301945	Thymic Epitheli... Thymic Carcinom... Thymoma Thymoma and Thy...	Artificial Inte... Recurrence Pred...	-	Erasmus Medical Center
Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer	NCT00024076	Lung Cancer Malignant Mesot... Metastatic Canc... Thymoma and Thy...	radiofrequency ...	-	Jonsson Comprehensive Cancer Center
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer	NCT00372840	Breast Cancer Colorectal Canc... Lung Cancer Malignant Mesot... Prostate Cancer Psychosocial Ef... Thymoma and Thy...	educational int... psychosocial as... quality-of-life...	18 Years - 120 Years	Fox Chase Cancer Center
Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy	NCT02049047	Thymoma and Thy...	Everolimus	18 Years -	Istituto Clinico Humanitas
Chemotherapy Combined With Pembrolizumab in Treating Patients With Thymoma and Thymic Carcinoma	NCT04554524	Thymoma and Thy...	Chemotherapy+Pe...	18 Years -	Tang-Du Hospital
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer	NCT00372840	Breast Cancer Colorectal Canc... Lung Cancer Malignant Mesot... Prostate Cancer Psychosocial Ef... Thymoma and Thy...	educational int... psychosocial as... quality-of-life...	18 Years - 120 Years	Fox Chase Cancer Center

Spots Global Cancer Trial Database for thymoma and thymic carcinoma