Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Simultaneous Integrated Boost Technique

In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.

Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique

Toxicity score using Common Terminology for Adverse Events (CTCAE)

Questionnaires: European Organization for Research and Treatment of Cancer Quality of Life - Core Questionnaire (EORTC QLQ-C30), Quality of Life Questionnaire - Breast Cancer Module (QLQ-BR23) and Adult Comorbidity Evaluation (ACE-27)

Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound

University Medical Center Groningen

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Micronutrients

Androgens

Cobalt

* Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent.
* Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.

* Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent.
* Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent.
* Entire uninvolved seminal vesicle when part of the seminal vesicle is involved with tumor: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent.
* Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.

The prostate and proximal seminal vesicles will be treated to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent.

Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.

Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.

HR-A

The prostate, proximal seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent.

The prostate and proximal seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 16 fractions for a total of 32 cobalt gray equivalent.

Electively treat the entire uninvolved seminal vesicle to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent when part of the seminal vesicle is involved with tumor.

Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.

Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.

HR-B

Curtis M Bryant, MD, MPH

The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months if the patient decides to receive ADT.

Prostate cancer is the most common noncutaneous cancer among men in the United States. The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer.

Proton therapy (PT) is a type of ionizing radiation therapy that reduces the dose of excess radiation delivered to normal tissues. By escalating the radiation dose just to the area of the known tumor within the prostate, one could potentially reduce the amount of excess radiation delivered to surrounding organs.This reduction in dose would improve the therapeutic ratio by improving disease control while minimizing the risk for additional toxicity.

In an effort to take advantage of dose escalation's potential for improving disease control but also to limit toxicity, the use of advanced imaging to identify prostate cancer and provide a focal radiation boost to the area have proven to be useful. Recent advances in MRI have made it the most promising technique in identifying and targeting IPTs, improving both cancer control rates and decreasing toxicity.

The study features hypofractionation and a simultaneous integrated boost to the MRI identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months.

Patients will be assigned to treatment group according to their lymph node risk or seminal vesicle invasion.

2 treatment groups:

* HR-A: Patients with \<15% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion on exam pretreatment diagnostic MRI.
* HR-B: Patient with ≥ 15% risk of positive pelvic nodes or with seminal vesicle invasion, without posterior extracapsular extension.

Prostate cancer is gender-specific. Biological males only.

Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer

A Phase II Study of Dose-Escalated Proton-Based Radiation Therapy Delivered With a Simultaneous Integrated Boost (SIB) to Intraprostatic Tumors (IPT) Visible on Pretreatment Magnetic Resonance Image

Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.

Assess physician-graded, severe (Grade 3-4), acute (early, within 90 days of treatment) genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Assess physician-graded, severe (Grade 3-4), late (beginning 90 or more days after treatment), cumulative 5 year genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Assess changes in patient-reported quality of life before and after treatment according to The International Index of Erectile Function (IIEF-5/IIEF-5m) which measures sexual function and the effect of radiation therapy; The International Prostate Symptom Score (IPSS) which measures urinary function and the effect of radiation therapy; and The Expanded Prostate Cancer Index Composite (EPIC) which measures different areas that may be affected by prostate cancer or its treatment.

Assess the overall survival, defined as the time from the start of treatment to the date of death of any cause, if data is available, at 5 years. Also, cause-specific survival will be calculated.

Assess local persistence or local recurrence of prostate cancer at 5 years. Local persistence is defined as the failure of the original abnormal tumor mass seen on cross sectional imaging and/or found on digital rectal exam to resolve in patients who also had a poor PSA response with a PSA nadir greater than 1 ng/mL. Local recurrence is defined as the development of any new abnormal prostate mass on cross sectional imaging or on digital rectal exam with previous exams or imaging showing no mass in the area prior to radiation therapy or after initial treatment.

Assess the cumulative rate development of distant metastasis up to 5 years after end of radiation. This will be an aggregate binary, yes/no response based on evidence acquired from sources including CT scan, bone scan, and/or PET/CT scan.

University of Florida

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Lymphoma

Neurotoxicity Syndromes

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

Anti-Infective Agents

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Cytarabine

Methotrexate

Each freshly-diagnosed patient with primary CNS lymphoma will be treated with combined chemoradiation in a sandwiched way, in which 2 cycles of induction chemotherapy with intravenous methotrexate (MTX in a conventional dose of 1g/m2) and intrathecal MTX are followed by a complete course of hyperfractionated WBRT and then high-dose cytarabine for 2 cycles.

A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy

Chi-Cheng Chuang, M.D.

Shinn-Yn Lin, M.D.

Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole-brain radiation therapy (WBRT) or methotrexate (MTX)-based combined modality therapy integrating chemotherapy with cranial irradiation in a sandwiched manner. No matter whether the dosage of MTX is high or conventional, combining chemotherapy with WBRT greatly improves intracranial tumor control and even survival outcomes. However, delayed treatment-related neurotoxicity and neurocognitive sequelae emerged as a significant debilitating complication in PCNSL patients, especially when effective combined chemoradiation can achieve disease control and long-term survival rates. Therefore, by delivering hyperfractionated conformal WBRT plus SIB, this prospective cohort study aims to accomplish both optimal intracranial control and minimal WBRT induced neurocognitive decline. Additionally, by administering objective multi-domain neurobehavioral/neurocognitive assessments, the change in neurocognitive functions (NCFs) before and after the course of hyperfractionated conformal WBRT will be investigated and analyzed.

According to the treatment guidelines for treating newly-diagnosed PCNSL patients, combined chemoradiation in which the WBRT course is sandwiched between initial courses of MTX and the later courses of chemotherapy with Ara-C is the treatment of mainstay at our institute. Employing the technique of a conformal CT treatment planning, the WBRT course is delivered in the manner of hyperfractionation with a reduced cumulative dose of 3600 cGy in 30 fractions during 3-4 weeks, administered twice daily in 1.2 Gy - fractions with at least 6 hours between fractions. By virtue of multidisciplinary management and teamwork including neurosurgery, hematology, radiation oncology, and neuroimaging expertise, it is attempted to recruit all potentially eligible patients with newly-diagnosed PCNSL. Most importantly, a professional neuropsychologist participates in this research project to integrate neurobehavioral outcomes into the prospective study. Accordingly, a battery of neuropsychological measures is used to evaluate predetermined NCFs for the studied patients. The test battery is composed of six standardized neuropsychological tests, covering four domains sensitive to disease and treatment effects (executive function, attention, verbal memory, information processing). The primary outcome measure is the change in patients' capability of information processing indicated by the Paced Auditory Serial Addition Test-Revised (PASAT-R), from the baseline before receiving the WBRT course to the follow-up after undergoing the entire courses of combined chemoradiation.

This prospective cohort study aims to thoroughly examine newly diagnosed PCNSL patients by using a standard battery of neurobehavioral/neurocognitive functions. Additionally, a better intracranial disease control is expected since the WBRT course relies on a highly conformal treatment planning integrated with the individualized arrangement of simultaneous integrated boost (SIB) to escalate the focal dose irradiating the originally involved site(s). Moreover, WBRT-related neurocognitive sequelae might be significantly less likely to occur because the WBRT course is delivered in the fashion of hyperfractionation, indicating a significantly lower dose per fraction and a reduced cumulative dose. Furthermore, it is anticipated the investigators will analyze which neurobehavioral domain would predict the treatment-related neurocognitive impacts to the largest extent in newly diagnosed PCNSL patients treated with cranial RT combined with or without MTX based chemotherapy according to the multidisciplinary treatment guidelines implemented at a single institute.

Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost

Prospective Neurobehavioral Evaluation in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost

The Paced Auditory Serial Addition Test-Revised is an assessment of information processing, used to assess the capacity and speed of information processing, as well as sustained and divided attention.

The Word Sequence Learning Test is an assessment of verbal memory. To evaluate auditory memory of verbal information without context.

The Modified Card Sorting Test is an assessment of executive function, related to conceptual formation and mental shifting.

The Trail Making Test is an assessment of speed and flexibility, used to measure the ability of visual attention and task switching.

The Semantic Association of Verbal Fluency Test is an assessment of verbal fluency, related to frontal and temporal cortex.

A measure of the ability of phonemic and semantic variants.

Neurocognitive assessment including: Paced Auditory Serial Addition Test-Revised

Questionnaires include: Beck Depression Inventory (BDI). The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used psychometric tests for measuring the severity of depression.

The BDI contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:

0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.

Questionnaires include: Beck Anxiety Inventory (BAI). The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults.

The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are:

0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.

Questionnaires include: National Taiwan University Irritability Scale Self Evaluation(NTUIS-Self), National Taiwan University Irritability Scale-Family Evaluation (NTUIS-Family).

The National Taiwan University Irritability Scale (NTUIS) is a self-reported scale with validated and reliable psychometric properties, to specifically evaluate irritability.

The NTUIS required patients to examine their irritability before and after disease.

The NTUIS is a 6-point Likert scale with 18 items. Each item was rated 1 (totally non-matched to patient's conditions) to 6 (totally matched to patient's conditions) with descriptions anchoring each matching level. Since "excessive emotional (e.g. anger and annoyance) and behavioural (e.g. verbal aggression) responses to stimuli" were used as the operational definition of irritability, the items considering anger, verbal aggression and annoyance were selected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique	NCT02505906	Breast Cancer	Simultaneous In...	18 Years -	University Medical Center Groningen
Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique	NCT02505906	Breast Cancer	Simultaneous In...	18 Years -	University Medical Center Groningen
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer	NCT03624660	Adenocarcinoma ...	HR-A HR-B	18 Years - 100 Years	University of Florida
Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost	NCT04006561	Primary CNS Lym... Brain Lymphoma	A treatment pro...	18 Years - 80 Years	Chang Gung Memorial Hospital

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