Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist

Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist

LHRH agonist

Pelvic Radiation

SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)

Stereotactic Body Radiotherapy (SBRT)

CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)

Conventional Radiotherapy (CRT) Prostate Boost

Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC

Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC

Theodorous Tsakiridis, MD, FRPC

Naghmeh Isfahanian, MD, FRCPC

Theodoros Tsakiridis, MD, FRCPC

A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.

In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.

Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)

To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome

long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome

short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)).

Total IPSS is between 1-35 / lower score shows better function.

Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI)

Sanofi

Juravinski Cancer Center

Term Professional staff

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Conventional Radiotherapy (CRT)

Anand Swaminath

Tim Whelan

A multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (NSCLC). Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) or conventional radiotherapy (CRT) in a 2:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. The primary outcome is local control (LC). The trial will be conducted at 16-20 clinical centres throughout Canada.

Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients

A Randomized Trial of Medically-Inoperable Stage 1 Non-small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy

Local control is the absence of local recurrence during the study period. This is the time from randomization to primary tumour failure or marginal failure.

Overall Survival is defined as the time from randomization to death from any cause. Alive subjects will be censored on the date of last follow-up.

Disease-Free Survival is defined as the time from randomization to the earliest recurrence of disease or to death attributed to lung cancer.

Event-Free Survival is defined as the time from randomization to the earliest documented recurrent disease or death from any cause.

Lung Cancer-Specific Survival is defined as the time from randomization to death attributable to lung cancer

Radiation Treatment-Related Death is defined as death occurring between 1 to 12 months following treatment, and caused directly by radiation toxicity attributed to either catastrophic hemorrhage or to severe radiation pneumonitis leading to death

Acute Toxicity will be assessed at 3 months post-randomization and includes fatigue, dyspnea and esophagitis. Late toxicity will be assessed beyond 3 months and up to 5 years and includes radiation pneumonitis, chest wall pain and rib fracture.

Impact on quality of life will be assessed with the European Organization for Research in Treatment of Cancer and the Lung Cancer-specific Module 13 questionnaires.

Cost-Utility will be assessed using the European Quality of Life questionnaire in conjunction with the overall survival results

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)	NCT03380806	Prostate Cancer	LHRH agonist Pelvic Radiatio... Stereotactic Bo... Conventional Ra...	18 Years - 85 Years	Juravinski Cancer Center
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)	NCT03380806	Prostate Cancer	LHRH agonist Pelvic Radiatio... Stereotactic Bo... Conventional Ra...	18 Years - 85 Years	Juravinski Cancer Center
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients	NCT01968941	Non-small Cell ...	Stereotactic Bo... Conventional Ra...	18 Years -	Ontario Clinical Oncology Group (OCOG)
Stereotactic Body Radiotherapy Versus Conventional Radiotherapy in Medically-Inoperable Non-Small Lung Cancer Patients	NCT01968941	Non-small Cell ...	Stereotactic Bo... Conventional Ra...	18 Years -	Ontario Clinical Oncology Group (OCOG)

Spots Global Cancer Trial Database for conventional radiotherapy (crt)