Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Syndrome

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Facies

Head and Neck Neoplasms

Solitary Pulmonary Nodule

Sarcoma

Histiocytoma, Malignant Fibrous

Mesothelioma

Mesothelioma, Malignant

Liposarcoma

Osteosarcoma

Mouth Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Chondrosarcoma

Fibrosarcoma

Histiocytoma

Carcinoma, Bronchogenic

Hemangiosarcoma

Kidney Neoplasms

Carcinoma, Small Cell

Leiomyosarcoma

Phyllodes Tumor

Hemangioma

Adenoma, Pleomorphic

Parathyroid Neoplasms

Otorhinolaryngologic Neoplasms

Pancoast Syndrome

Adenosarcoma

Lymphangiosarcoma

Myosarcoma

Mixed Tumor, Mesodermal

Tracheal Neoplasms

Facial Neoplasms

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Soft Tissue Sarcoma

Malignant Mesothelioma

Oral Cancer

Malignant Mixed Mullerian Tumor

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Fluorouracil

Belinostat

Parathyroid Hormone

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Histone Deacetylase Inhibitors

Enzyme Inhibitors

300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1

belinostat

250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.

5-Fluorouracil (5-FU)

Topotarget A/S

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors

Valerio Therapeutics

Multiple Pulmonary Nodules

Exanthema

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density)

Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density). Overall, participants in the less frequent arm are expected to undergo 30% fewer surveillance imaging tests.

More Frequent Surveillance Strategy

Less Frequent Surveillance Strategy

Michael K Gould, MD, MS

This study will compare two clinically accepted protocols for surveillance imaging in individuals who are found to have a small pulmonary nodule on chest computed tomography (CT) scans.

The investigators will conduct an unblinded, prospective, pragmatic, cluster-randomized, comparative effectiveness trial of more intensive versus less intensive CT surveillance of patients found to have small pulmonary nodules in diverse health care settings. The goal of this pragmatic clinical trial is to identify the surveillance strategy that will maximize early diagnosis for individuals with cancerous nodules, while minimizing unnecessary surveillance of patients without cancer that can result in emotional stress, exposure to harmful ionizing radiation, and the discovery of incidental findings that may lead to unnecessary treatment.

The Watch the Spot Trial

The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules

We plan to share de-identified IPD for all study variables with other researchers on request as long as there is an acceptable justification

Among individuals with small pulmonary nodules identified either incidentally or by screening, compare more versus less intensive surveillance to determine the number of cancerous nodules that progress beyond T stage T1a.

Compare patient-reported emotional distress

Compare patient-reported general health status

Compare effective radiation doses received.

Compare adherence to the recommended protocols for CT surveillance, and adherence to use of low radiation dose techniques.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
The Watch the Spot Trial	NCT02623712	Solitary Pulmon... Coin Lesion, Pu... Lung Neoplasms Carcinoma, Non-...	More Frequent S... Less Frequent S...	35 Years -	Kaiser Permanente
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics

Spots Global Cancer Trial Database for coin lesion, pulmonary