Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

All Drugs and Chemicals

Herbal and Botanical

Hormones

Immunomodulating Agents

Hormone Antagonists

Cola

Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.

Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.

Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

Palliative Radiotherapy

Pre-specified based on the standard of care approach for that patient.

Chemotherapy

Hormone therapy

Immunotherapy

Targeted Systemic Therapy

Observation

The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board.

Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily).

Stereotactic Ablative Radiotherapy

Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.

The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR.

Surgery

Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.

Radiofrequency Therapy (RFA)

Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.

Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation.

Fractionated Radiation

David Palma, MD, PhD

Robert Olson, MD, MSc

Houda Bahig, MD, PhD

This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease.

Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.

Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.

The time from randomization until commencement of any systemic anti-cancer therapy, or date of last follow-up, whichever occurs first.

Will be collected for SABR (as a binary endpoint; yes/no), and non-SABR (yes/no).

David Palma

Principal Investigator

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Acute Graft Versus Host Disease

Neuroepithelioma

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.

Standard of care fractionated radiation therapy will be given to the tumor.

Standard of care temozolomide will be given along with radiation therapy

Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.

Asim Bag, MD

The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.

Once eligibility criteria have been assessed and the informed consent is obtained, participants will undergo a screening process to further ensure eligibility. Screening prior to registration will comprise a review of pathology reports, postoperative magnetic resonance Imaging (MRI) images, operative reports, and medical history; general physical and neurologic exams; routine blood work; and urine pregnancy test for women of childbearing age.

The study is intended to evaluate the response of radiation treatment (RT). The consent process will be performed between the surgery and the start of RT. RT will be prescribed as per the discretion of the treating radiation oncologist as per the University of Alabama at Birmingham Department of Radiation Oncology treatment protocol in combination with temozolomide.

MRIs will be obtained before start of RT, after completion of 20 +/- 4 Gy. after completion of 40+/- 4 Gy and after the entire radiation treatment. Conventional MRIs including perfusion sequences and whole brain spectroscopy will be performed as a part of the research study. The data obtained from this research studies will not be used for clinical management.

Volumes of the enhancing component, non enhancing component, choline/N-acetyl aspartate (Cho/NAA) will be measure before, during and after RT as described before. Cerebral blood volume (CBV) of the tumor will also be calculated from perfusion imaging at each time point. Apparent diffusion co-efficient (ADC) of the tumor will be calculated from the diffusion imaging.

All the patients will be followed up with imaging and will be treated as per the standard of care. Patients will return for clinical evaluation and standard of care imaging approximately 4 weeks from the completion of the radiation therapy. After that, all the patients will be treated with standard of care maintenance temozolomide therapy and will return every 2-3 months for clinical evaluation and standard of care imaging.

At the time of recurrence, the recurrence site will be assessed and will be compared with the imaging parameters obtained during radiation treatment. Time to recurrence will also be calculated and will be correlated with the imaging parameters.

Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma

Percentage change of the Cho/NAA, ADC and nCBV from baseline to the end of radiation therapy, RT will be used for assessment of time to progression.

Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.

Diffusion MRI will be used for assessment of measures tumor cellularity (with minimum apparent diffusion co-efficent, ADC) during the course of fractionated radiation treatment.

MRI will be used for assessment of measures tumor volume.

Perfusion MRI will be used for assessment of tumor angiogenesis (with median normalized cerbral blood volume, nCBV) during the course of fractionated radiation treatment.

University of Alabama at Birmingham

Associate Professor

This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.

Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor.

Temozolomide: Standard of care temozolomide will be given along with radiation therapy

MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.

Chemoradiation With MRI Assessment

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Glioblastoma Diagnosis

Five subjects participated in the baseline. Two of them voluntarily withdrew. Only 3 subjects completed the treatment.

The study enrollment was much less than anticipated. With only 5 subjects in the study, it is difficult to make a meaningful conclusion.

Asim K. Bag, MD Bag

The baseline and the end of therapy MRI parameters are compared.

Due to very small accrual, the statistical analysis couln't be performed.

The number of participants dropped from 5 to 3 because 2 participants withdrew from the study. The chemical evaluation could not be evaluated due to poor quality imaging.

Number of Participants With the Changes of the Chemical Environment of the Tumor

Baseline

Early in therapy (At 2 weeks in therapy)

Late therapy (At 4 weeks in therapy)

At completion (At 6 weeks from baseline)

Diffuion MRI was performed before, during and after completion of radiation

Chemoradiation Arm

Changes of Tumor Cellularity

Volumetric MRI was performed before, during and after completion of radiation

Measurements performed only in 2 subjects .

Changes of Tumor Volume

baseline

Perfusion MRI was performed before, during and after completion of radiation

Changes of Tumor Angiogenesis

Time to Progression

Overall Study

Digestive System Diseases

Esophageal Neoplasms

Esophageal Cancer

Paclitaxel

Carboplatin

Tislelizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

All patients receive Tislelizumab, q3week; chemotherapy with carboplatin and paclitaxel weekly concurrently for 5 weeks before surgery. Tislelizumab is continued q3week in all patients after surgery for a total of one year from the start of study.

Participants will receive 200mg, every three weeks for up to 51 weeks

Intravenous Tislelizumab

Carboplatin (AUC2) and Paclitaxel (50mg/m2), Weekly x 5 weeks

Fractionated radiation

Surgical resection of cancer after chemoradiation therapy when no disease progression found.

Esophagectomy

Zhonglin Hao, MD, PhD

This study aims to determine the effects of chemoradiation and Tislelizumab on Esophageal/EGJ Cancer before and after surgery.

Esophageal cancer patients in this trial will receive chemoradiation therapy with tislelizumab, which is an anti-PD-1 antibody, before surgery. Patient will be evaluated for complete pathological response or major pathological response rate following chemoradiation. Patient will continue on to get tislelizumab after surgery to complete total of a year of treatment. They will be evaluated for PFS and OS. Throughout the study, drug tolerability and toxicities will be monitored.

ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer

Pathological complete response (pCR) rate in patients treated with tislelizumab and chemoradiation followed by surgery. The pCR rate will be estimated by number of patients who has had pCR divided by the total number of evaluable patients treated with neoadjuvant therapy before surgery. The exact 95% confidence interval of the pCR rate will be provided.

The time from the participants' date of surgery to the date of disease progression or death, whichever occurs first

The number of patients who had 90% or more tumor showing necrosis divided by the total number of evaluable patients treated with neoadjuvant therapy before surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.	NCT05717166	Metastatic Tumo...	Palliative Radi... Chemotherapy Hormone therapy Immunotherapy Targeted System... Observation Stereotactic Ab... Surgery Radiofrequency ... Fractionated Ra...	18 Years -	Lawson Health Research Institute
Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma	NCT03168919	Glioma	Fractionated Ra... Temozolomide MRI	18 Years -	University of Alabama at Birmingham
Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma	NCT03168919	Glioma	Fractionated Ra... Temozolomide MRI	18 Years -	University of Alabama at Birmingham
ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer	NCT05245760	Esophageal Canc... Esophagogastric...	Intravenous Tis... Chemotherapy Fractionated ra... Esophagectomy	18 Years - 80 Years	University of Kentucky

Spots Global Cancer Trial Database for fractionated radiation