Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Stomach Neoplasms

Carcinoma

Esophageal Neoplasms

Pancreatic Neoplasms

Sarcoma

Urinary Bladder Neoplasms

Melanoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

Skin Neoplasms

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Kidney Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Soft Tissue Sarcoma

Renal Cell Carcinoma

Small Intestine Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Doxorubicin

Liposomal doxorubicin

Immunomodulating Agents

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 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).

Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy.

The experimental arm consists of SBRT (and standard of care systemic therapy). Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.

Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation.

Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.

Stereotactic body radiotherapy

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 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).

Palliative RT

EORTC HQ

Robbie Van den Begin, MD

Pieter Deseyne, MD

Piet Ost, MD

David Pasquier, MD

Antonin Levy, MD

Daniela Alterio, MD

Hossein Hemmatazad, MD

Matthias Guckenberger, MD

Jennifer Sherriff, MD

Shane Zaidi, MD

Matthias Guckenberger

Piet Ost

This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.

Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.

The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.

Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.

Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:

* Development new metastatic lesions,
* Cancer-related death.

Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events:

* Presence of more than 5 metastases at a specific timepoint during follow-up,
* Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible),
* Cancer-related death.

Anticancer Fund, Belgium

Rising Tide Foundation

European Organisation for Research and Treatment of Cancer - EORTC

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Carcinoma, Hepatocellular

Respiratory Tract Infections

Neoplasms, Second Primary

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

Prior to receiving radiation treatment, it is recommended that you take medications to reduce the chance of nausea related to therapy. The treatment will take approximately 30 minutes.

Laura Dawson, MD

Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative radiotherapy for advanced liver cancer have not been well studied.

This study is designed to help to see whether palliative radiation therapy is effective in controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases might affect the quality of life of patients receiving such therapy. This information will help the doctors understand if there are specific conditions under which radiation therapy is more effective and worthwhile, and how it may affect the quality of life for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.

The liver is one of the most common sites with tumour involvement, including both primary and metastatic disease. Gastrointestinal tumours, breast, lung and melanoma are the most common primary sites for hepatic metastases. Hepatocellular carcinoma(HCC) is the sixth most common cancer worldwide, with over 600,000 new cases diagnosed per year. It is the third most common cause of cancer related death.Although, predominately a disease in Asia and sub-Saharan Africa, the incidence of HCC is increasing in North America. The use of radiation in unresectable hepatocellular carcinomas, as well as hepatic metastases, for palliation is uncommon in clinical practice.

This may be because there is a prevailing perception that radiation to the liver will inevitably lead to radiation induced liver disease (RILD). However, several single institution, predominantly retrospective studies, have demonstrated effective palliation for locally advanced HCC as well as hepatic metastases with minimal toxicity.In this study, palliative radiotherapy (RT), delivered in one fraction of 8Gy, will be given to symptomatic patients who are not candidates for radical treatment. We hypothesize that palliative RT will provide symptomatic relief to a large fraction of the patients, with both primary and metastatic disease. We also expect minimal toxicities at this treatment dose.

Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)

Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases

Princess Margaret Hospital, Canada

University Health Network, Toronto

Carcinoma, Squamous Cell

Recurrence

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cycle 1 of this clinical trial is 56 days in duration to allow for the systematic addition of each agent to the combination regimen. For cycle 2 and all subsequent cycles, the treatment cycle will be 21 days in length.

INCB081776 will be given orally on a daily basis. The highest safe/tolerable dose and schedule will be established by the ongoing phase 1 clinical trial of INCB081776 plus INCBMGA00012 (NCT03522142), which is 120 mg daily.

INCB081776

Immune checkpoint blockade with anti-PD-1 (Pembrolizumab) will be given as 200 mg IV on cycle 1 day 15 and cycle 1 day 36. Starting from cycle 2, pembrolizumab will be given on day 1 on each subsequent cycle.

Palliative RT will be given as either 24 Gy in 3 fractions (8 Gy per fraction) or 20 Gy in 5 fractions (4 Gy per fraction). The palliative radiation therapy dose will be determined based on the clinical judgment of the treating radiation oncology physician. Palliative RT must be completed between cycle 1 day 29 to cycle 1 day 33. After completion of palliative radiation therapy, patients will continue with additional cycles of INCB081776 and pembrolizumab until disease progression, intolerance to the combination regimen, or patient withdrawal.

Cancer Connect

Justine Bruce, MD

Deric Wheeler, PhD

This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months.

Primary Objective

• To evaluate the safety and tolerability of INCB081776 in combination with pembrolizumab and standard palliative radiation therapy in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

Secondary Objectives

• To determine the preliminary efficacy of INCB081776 in combination with pembrolizumab plus palliative radiation therapy in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck. The irradiated lesion (lesion A) will not be included in the analysis.

Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma

Pilot Study of INCB081776 Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade With Pembrolizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Frequency of AEs through physical examinations, by evaluating changes in vital signs, through clinical laboratory blood sample evaluations.

Duration of AEs through physical examinations, by evaluating changes in vital signs, through clinical laboratory blood sample evaluations.

Severity of AEs through physical examinations, by evaluating changes in vital signs, through clinical laboratory blood sample evaluations. Severity will be reported by Grade between 1 (mild) and 5 (death).

Defined as the percentage of participants having CR or PR per RECIST 1.1. The irradiated lesion (lesion A) will not be included in the analysis.

Defined as the percentage of participants having complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.

Defined as the time from earliest date of response until the earliest date of disease progression or death per RECIST 1.1 due to any cause, if occurring sooner than progression.

National Institute of Dental and Craniofacial Research (NIDCR)

National Cancer Institute (NCI)

University of Wisconsin, Madison

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)	NCT04498767	Gynecologic Can... Skin Cancer Head and Neck C... Sarcoma Renal Cancer Bladder Cancer Upper Urinary T... Pancreatic Canc... Hepatobiliary C... Gastric Cancer Small Bowel Can... Esophageal Canc... Melanoma Colon Cancer Oligometastasis	Stereotactic bo... Palliative RT	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)	NCT00923897	Hepatocellular ... Hepatic Metasta...	Palliative RT	18 Years -	University Health Network, Toronto
Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma	NCT06308913	Head and Neck S...	INCB081776 Pembrolizumab Palliative RT	18 Years -	University of Wisconsin, Madison
Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma	NCT06308913	Head and Neck S...	INCB081776 Pembrolizumab Palliative RT	18 Years -	University of Wisconsin, Madison

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