Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment

Adaptive Radiation

Don Yee, MD, FRCPC

This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.

Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray

AHS Cancer Control Alberta

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Leuprolide

Relugolix

Goserelin

Bicalutamide

Flutamide

Androgen Receptor Antagonists

Hormones

Hormone Antagonists

* Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
* Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.

Device that will be used to administer radiotherapy

Ethos Varian treatment system

Radiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart.

Adaptive stereotactic body radiotherapy

Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Patients should initiate ADT beginning no sooner than 60 days prior to start of radiation. ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix). Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH agonist/antagonist or until the end of radiation, depending on institutional standard and physician preference.

Agent selection is per treating physician discretion and will be administered per institutional standard and FDA-approved labeling.

Androgen deprivation therapy

Amit Bhatt, M.D., Ph.D.

Eric Laugeman, M.S.

Jeff Michalski, M.D., MBA, FASTRO

Yi Huang, M.S.

Hiram Gay, M.D.

This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.

Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer

-The EPIC-26 is used to assess health related quality of life among persons with prostate cancer. It contains 5 domains of urinary incontinence, urinary irritability/obstructive, bowel, sexual, and hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.

-The EQ-5D-5L is a commonly used and reliable questionnaire used to assess patient perception of their current health state. Patients are asked about their levels of difficulty with mobility, self-care, and usual activities, and about their pain/discomfort and anxiety/depression levels on a 5-point scale where the response "I have no problems" = 1 and "I am unable/have extreme" = 5.

-Time from start of radiotherapy to biochemical relapse, radiographic recurrence with development of local, regional or distant metastases, or death to due to any cause

* Biochemical recurrence free survival: Defined as a \>2 ng/mL rise in the PSA above the nadir post initial treatment or evidence of radiographic progression.
* Time from start of radiotherapy to recurrence of prostate cancer by PSA criteria or radiographically)

-Time from start of radiotherapy treatment to radiographic diagnosis of metastatic disease (M1 disease) or death from any cause

-Time from start of radiotherapy to death due to prostate cancer.

-Time from start of radiotherapy to death from any cause

Varian Medical Systems

Washington University School of Medicine

Digestive System Diseases

Carcinoma, Squamous Cell

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Anti-Infective Agents

Capecitabine

Fluorouracil

Mitomycins

Mitomycin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg/meters squared IV on Day 1) and 5-Fluorouracil (1000mg/meters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg/meters squared in two divided doses by mouth on days of radiotherapy).

Subjects will receive 54 Gy of radiation delivered 5 day a week for 6 weeks, 30 radiation treatments total. Intensity-Modulated photon radiation therapy will be delivered on a Varian Ethos linear accelerator. Daily image-guided radiation therapy (IGRT) is required. All treatments will have artificial-intelligence (AI) daily adaptations of the radiation plan to optimize the radiation dose to the targeted area and minimize radiation dose to the normal surrounding organs such as the bowel.

Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery

As part of the subjects' treatment, 10 mg/meters squared of Mitomycin C will be administered intravenously (IV-into the vein) on Day 1 and Day 29.

Mitomycin-C

As part of the subjects' treatment, 1g/meters squared/day for 4 days of 5-Fluorouracil will be administered by continuous infusion on Days 1-4 (for 96 hours) and Days 29-32 (for 96 hours). 5-Fluorouracil or capecitabine will be administered per the physician's discretion.

5-Fluorouracil

As part of the subjects' treatment, 825 mg/meters squared per day, divided into 2 daily doses, will be taken on days of radiotherapy. Capecitabine or 5-FU will be administered per the physician's discretion.

Mariamne Reyna

Lisa Kachnic, MD

David Horowitz, MD

This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.

The standard treatment for Human Papilloma Virus (HPV)-positive locally advanced anal cancer (described as a tumor that is greater than 4 cm in size, or with positive lymph nodes) is 54 Gy of radiation treatment to the anal canal and primary tumor planning total volume (PTV), 50.4-54 Gy to positive nodal PTV and 45 Gy to elective lymph node PTV with 5-fluorouracil (5-FU) and mitomycin-C chemotherapy administered at the same time as radiation in 30 fraction (treatments) delivery. During the six week course of radiotherapy, there is often a notable decrease in volume of the tumor (both primary and regional nodes), as early as one week into treatment, detected on weekly on-board Cone Beam Computed Tomography (CBCT), which is a scan done on the treatment machine while patients receive radiation to ensure that the tumor is being treated and normal tissue is not. However, CT simulation (a CT scan used to plan radiation treatment) and re-planning of the treatment to account for the tumor shrinkage are not routinely performed due to time, patient inconvenience and staffing resources. As such, daily adaptive radiation, which can generate a new CT-based plan using the anatomy of the day, may be a time efficient method to both plan and treat the patient.

Adaptive Radiation in Anal Cancer

Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma

This is defined by the time the first cone beam computed tomography to the end of treatment delivery for each treatment.

Toxicity of treatment will be analyzed using NCI-CTCAE v5.0.

Complete response to treatment (CR) is defined as absence of detectable cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer	NCT01426841	Small Cell Lung...	Adaptive Radiat...	18 Years -	AHS Cancer Control Alberta
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer	NCT01426841	Small Cell Lung...	Adaptive Radiat...	18 Years -	AHS Cancer Control Alberta
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer	NCT05628363	Prostate Cancer Cancer of the P...	Ethos Varian tr... Adaptive stereo... Androgen depriv...	18 Years -	Washington University School of Medicine
Adaptive Radiation in Anal Cancer	NCT05838391	Anal Squamous C...	Artificial Inte... Mitomycin-C 5-Fluorouracil Capecitabine	18 Years -	Columbia University

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