Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Condylomata Acuminata

Warts

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Skin Diseases, Infectious

Herbal and Botanical

All Drugs and Chemicals

Polyphenon E Ointment 10%, Polyphenon E Ointment 15%

Karl R. Beutner, M.D., Ph.D.

The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.

External genital warts are non-malignant tumors caused by infections of the human papillomavirus (HPV), mainly types 6 and 11. Genital wart infections have one of the fastest growing incidence rates of all sexually transmitted diseases, with about 1% of sexually active adults in the United States suffering from this infection and at least 15% with subclinical infection. None of the current treatment options (with exception of interferon) has been subjected to controlled prospective clinical trials, although they are generally regarded as safe and effective. However, one of their major disadvantages is that they are painful and may cause scarring. Additionally recurrence of warts can often be observed. Against this background the study tries to evaluate another effective and well tolerated therapeutic option by using an extract of green tea leaves.

Comparison: Polyphenon E Ointment 10%, Polyphenon E Ointment 15%, placebo

Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts

A Randomized, Double-Blind, Three-Arm Parallel-Group, Placebo-Controlled Phase 3 Trial to Investigate the Clinical Efficacy and Safety of Polyphenon E in the Treatment of External Genital Warts

MediGene

Neoplasms

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Neoplasms, Squamous Cell

Anal Cancer

Antineoplastic Agents

Fluorouracil

Mitomycins

Mitomycin

Panitumumab

Antineoplastic Agents, Immunological

5 FU = 400 or 600 or 80 or 1000 mg depending of phase I results, days 1 to 4 weeks 1, 5 and 8 mitomicyne = 10 mg/m² day 1 week 1 and days 1, weeks 5 and 8 Panitumumab = 3 or 6 mg/kg (depending of phase I results) days 1, weeks: 1, 3, 5, 8 and 10

Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²

radiochemotherapy

Véronique VENDRELY, MD

Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.

Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

Federation Francophone de Cancerologie Digestive

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts	NCT00449982	Condylomata Acu...	Polyphenon E Oi...	18 Years -	MediGene
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus	NCT01581840	Epidermoid Carc... Anus	radiochemothera... Panitumumab	18 Years -	Federation Francophone de Cancerologie Digestive
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus	NCT01581840	Epidermoid Carc... Anus	radiochemothera... Panitumumab	18 Years -	Federation Francophone de Cancerologie Digestive
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus	NCT01581840	Epidermoid Carc... Anus	radiochemothera... Panitumumab	18 Years -	Federation Francophone de Cancerologie Digestive

Spots Global Cancer Trial Database for anus

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

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