Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vitamins

Anesthetics

Acetic Acid

Retinol acetate

Under local anaesthesia, taking proper aseptic precautions, 40% acetic acid (total dose not exceeding 3 times the diameter of the mass, (not more than 2ml in one sitting), will be injected into the mass through the percutaneous route

Under aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance.

Subrat K Acharya, DM

The purpose of this study is to assess the efficacy of Radiofrequency ablation (RFA) and percutaneous acetic acid ablation (PAI) in the management of small hepatocellular carcinoma (HCC) in patients of cirrhosis of liver.

Setting The study would be conducted at the All India Institute of Medical Sciences, New Delhi, a tertiary care teaching hospital, in the departments of Gastroenetrology and Radiodiagnosis.

Sample size Taking RFA as a standard procedure with an estimated success rate of 95%, a sample size of minimum 27 for each arm is required to detect an equivalence difference of 10%, assuming that PAI has a success rate of 85%. This sample size is expected to provide a power of 80%.

Randomization

* Stratified randomization of Child A and B will be done.
* Randomization into A (Acetic acid) and B (Radiofrequency ablation) will be done.

Diagnostic criteria

* Cirrhosis of liver- Diagnosis will be founded on the basis of clinical, biochemical, imaging and endoscopy findings.

Hepatocellular carcinoma- when any one of the following is present

1. Two imaging modalities (dual phase CT (DPCT)/ contrast enhanced Magnetic Resonance Imaging (MRI)) showing arterialization of the hepatic mass
2. AFP more than 400ng/ml along with arterialisation on one imaging modality (DPCT/ contrast enhanced MRI)
3. Fine needle aspiration cytology (FNAC)

Definitions

1. Local recurrence : When the Triple phase CT shows-

   * An area of nodular enhancement that abuts or surrounds the ablation defect or protrudes into the low attenuating necrotic tissue (may sometimes be seen only on arterial phase of CT)
   * Recurrent soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.
2. Fresh lesion- When a new lesion is seen in the liver at a site other than the primary site of the treated lesion with normal liver parenchyma intervening in between will be considered as a fresh lesion.
3. Residual disease or incomplete ablation When the follow up Triple phase CT shows-

   * Residual nodular enhancement that abuts or surrounds the low attenuating ablation defect or protrudes into the low attenuating necrotic tissue (may sometimes be seen only on arterial phase of CT)
   * Residual soft tissue causing distortion of the otherwise smooth interphase with the adjoining liver parenchyma.
   * Concenteric hyperemia around the low attenuating defect showing area of focal nodularity or asymmetric thickness.
4. End point of ablation When the Triple phase CT shows-

   * A homogenous, well defined, uniformly low attenuating defect larger than the pretreatment size.
   * No residual soft tissue seen within or at the periphery of the low attenuating defect
   * Concentric hyperemia around the low attenuating defect of uniform thickness with no focal nodularity.

Follow up

1. Clinical follow up

   * All patients would be followed up in the Liver clinic monthly unless their clinical condition warrants earlier follow up
   * Liver function tests/ complete blood count would also be done at each visit and Alfafetoprotein (AFP) every six months
   * Patient tolerance, child's status would be estimated.
2. Imaging follow up

   * At one month, a dual phase CT would be done to ascertain the local response to therapy and the need to repeat the procedure. After achieving the end point after ablation (PAI and RFA, the DPCT would be done at 3 and 6 monthly intervals.

Duration of follow up - Since more than 80% recurrence occurs in 2 years therefore the duration of follow up would be 2 years after ablation.

Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis

Number of patients developing any complications during and after procedure will be noted.

Child status is calculated from the following 5 parameters

1. Bilirubin \< 2: 1, 2-3: 2 and \> 3 : 3 points
2. Albumin: \> 3.5: 1, 2.8-3.5 : 2 and \<2.8: 3 points
3. Prothrombin time( seconds over control): 1-3: 1, 4-6: 2 and \> 6: 3
4. Encephalopathy: None: 1, (grade 1 and 2): 2 and (grade 3 and 4): 3
5. Ascites: Absent: 1, slight: 2 and moderate: 3

Child A: score 5-6, Child B: 7-9 and Child C: 10 or more

All India Institute of Medical Sciences, New Delhi

Proffessor and Head

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Fibrinolytic Agents

Docetaxel

Fluorouracil

Cyclophosphamide

Epirubicin

Plasminogen

Plasminogen Inactivators

Taxane

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks

Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks

Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks

5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel

Christoph Thomssen, MD

Nadia Harbeck, MD

In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological criteria. Due to their high prognostic impact, the tumour-biological invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are potential candidates to effectively assess the risk of relapse in node-negative breast cancer. This study is aimed to compare the risk assessment by the traditional clinico-pathological factors and by tumour-biological factors. The second study question refers to the comparison between an adjuvant combination treatment with FE100C\*6 and a sequential treatment with FE100C\*3 and Docetaxel\*3.

1. To compare FEC\*6 with FEC\*3 followed by DOC\*3 with regard to:

   * the primary endpoint of the study: Disease-Free Survival (DFS)
   * the secondary endpoints: Overall Survival (OS), compliance, and toxicity of chemotherapy in each patient group
2. To compare patients with low risk according to clinico-pathological versus those according to biological risk criteria with regard to:

   * the proportion of low risk versus high risk patients
   * DFS
   * OS (secondary endpoint)

6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients

Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria

German Breast Group

Martin-Luther-Universität Halle-Wittenberg

Prof. Dr. Christoph Thomssen

Nutritional and Metabolic Diseases

Overweight

Obesity

Body Weight

Weight Loss

Overnutrition

Nutrition Disorders

Body Weight Changes

Individualized dietary counselling to reduce body weight

Individualized physical activity counseling to reduce body weight

Individualized dietary and physical activity counseling to reduce body weight

Materials and guidelines available to general public

Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

PADI

Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Patrick Maisonneuve

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial

weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

long-term weight control or maintenance via calibrated scales, stadiometer

change in total step count via pedometer device with electronic data transmission

change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire

change in dietary intake via Food Frequency Questionnaire

change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)

change in mood via State-Trait Anxiety Inventory (STAI) questionnaires

change in LDL, HDL, triglycerides and cholesterol assessed by blood samples

change in oestradiol assessed by blood samples

change in insulin assessed by blood samples

change in glucose assessed by blood samples

change in C-reactive protein assessed by blood samples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Ablation of Small Hepatocellular Carcinomas in Patients of Cirrhosis	NCT01438437	Hepatocellular ...	PAI RFA	12 Years - 70 Years	All India Institute of Medical Sciences, New Delhi
6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients	NCT01222052	Breast Cancer	5-Fluorouracil,...	18 Years - 70 Years	Martin-Luther-Universität Halle-Wittenberg
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology

Spots Global Cancer Trial Database for pai

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

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