Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Carboplatin infused into DCIS-involved duct on Days 1 \& 15

Carboplatin infused into DCIS-involved duct Day 1 and Normal Saline infused into DCIS-involved duct on Day 15

Normal Saline infused into DCIS-involved duct Days 1 \& 15

Carboplatin, 10 mg/ml, 10 ml (100 mg) infused into DCIS-involved duct on Days 1 \& 15

Carboplatin i.d. Days 1 & 15

Carboplatin 10 mg/ml, 10 ml (100 mg) i.d. DCIS duct on Day 1 Normal Saline, 10 ml i.d. DCIS duct on Day 15

Carboplatin i.d. Day 1; Normal Saline i.d. Day 15

Normal Saline, 10 ml, i.d. on Days 1 and 15

Normal Saline

Jane Doerr, RN, MSN

Andy Dorr, MD

William C Dooley, M.D., F.A.C.S.

Linda White, R.N.

Henry Kuerer, M.D.

The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.

This is a randomized, 3-arm, saline-controlled study involving women undergoing surgical management of DCIS. Forty-five (45) women who have been diagnosed with DCIS by core biopsy will receive intraductal administration of either carboplatin or normal saline (NS) into the DCIS-involved breast duct. Thirty (30) patients (i.e., 15 patients per arm) will receive two intraductal infusions of either 100 mg of carboplatin or NS on Days 1 and 15. Fifteen (15) patients will receive an intraductal infusion of 100 mg carboplatin on Day 1 and an intraductal infusion of NS on Day 15. Patients will undergo surgical resection 2 to 4 weeks following the Day 15 intraductal infusion (i.e. 4 to 6 weeks from diagnosis).

The effect of carboplatin on DCIS in the pre-treatment core biopsy specimen and the resection specimen will be assessed. Venous blood samples will be collected for carboplatin PK analysis pre-dose and at 30 minutes, 1, 2, 4, and 8 hours following intraductal infusions on Days 1 and 15.

Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

A Phase II Randomized Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ

Windy Hill Medical, Inc.

Windy Hill Medical, Inc. (Ms. Jane Doerr, R.N., Director of Clinical Development)

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Liver Neoplasms

Cholangitis

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Bile Duct Cancer

Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.

Systemic chemotherapy and bile duct stenting without RFA.

Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction

Intraductal biliary radiofrequency ablation

Johann von Felden, MD

The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:

* Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
* Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).

Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma

• Time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin \>5 mg/dl and/or cholangitis (fever \>38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent Endpoint Review Committee \[ERC\].)

The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in cancer patients. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

The EORTC QLQ-BIL21 consists of 21 questions: 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, in addition to 18 items grouped into 5 proposed scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). The response format is a four-point Likert scale.and designed to more specifically adress side effects.

A high scale score represents a higher response level.

Rate of clinical events defined as per primary outcome after 6 months follow up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)	NCT00669747	Ductal Carcinom...	Carboplatin i.d... Carboplatin i.d... Normal Saline	18 Years -	Windy Hill Medical, Inc.
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma	NCT06175845	Cholangiocarcin... Klatskin Tumor Bile Duct Cance... Liver Cancer	Intraductal bil...	18 Years -	Universitätsklinikum Hamburg-Eppendorf

Spots Global Cancer Trial Database for intraductal

Every month we try and update this database with for intraductal 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 intraductal

Every month we try and update this database with for intraductal 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 intraductal 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.