Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

1. Low Risk (T1-T2a, Gleason score 6, and PSA \< 10 ng/mL)
2. Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL)
3. High Risk (T3 - 4 , Gleason 8-10, and/or PSA \> 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3

Hypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups.

For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description).

Image guidance with cone beam CT will be mandatory before every treatment fraction.

HypoIGRT

Rafael Gadia, MD

Fabio Y Moraes, MD

Ana Cristina L Patrocinio, Graduated

Gabriela SM Siqueira, MD

Luiz Reis, MD, PhD

Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:

1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
2. Improving tumour control, mainly freedom from biochemical failure survival.

The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.

Primary Outcome Measures:

1. Acute and late radiation induced toxicities.

Secondary Outcome Measures:

1. Freedom from prostate cancer recurrence - freedom from biochemical failure survival;
2. Cause specific and overall survival
3. Aspects of quality of life and health economics

Study Design:

Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment

Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Study Population:

Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.

Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.

According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5

According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.

Defined as the percentage of participant on treatment group who are alive at 12 and 24 months after the start of treatment.

Defined as the cancer survival in the absence of other causes of death at 12 and 24 months after the start of treatment.

The Expanded Prostate Cancer Index Composite (EPIC) - Brazilian Portuguese version.

will be applied to assess urinary, bowel and sexual functions.

Hospital Sirio-Libanes

Head of Radiation Oncology - Hospital Sírio Libanês - Unidade Brasília

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

Cobalt

12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent

6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent

12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)

Peripherally located lung tumor

6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)

Centrally located lung tumor

Romaine C Nichols, MD

This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer	NCT02651896	Prostatic Neopl...	HypoIGRT	18 Years -	Hospital Sirio-Libanes
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)	NCT00875901	Non-Small Cell ...	Peripherally lo... Centrally locat...	18 Years -	University of Florida
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)	NCT00875901	Non-Small Cell ...	Peripherally lo... Centrally locat...	18 Years -	University of Florida
Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer	NCT02651896	Prostatic Neopl...	HypoIGRT	18 Years -	Hospital Sirio-Libanes
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)	NCT00875901	Non-Small Cell ...	Peripherally lo... Centrally locat...	18 Years -	University of Florida

Spots Global Cancer Trial Database for hypoigrt

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

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