Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

150 mg in a single daily dose, starting Day 1 through Day 22

Erlotinib

Jim Wright, MD

To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.

Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)

A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)

Roche Pharma AG

Ontario Clinical Oncology Group (OCOG)

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

The design of the study will be a prospective non-randomized cohort study with structured questionnaires administered to all enrolled patients at two or three time-points.

Questionnaires will be given before the patient watches a video educational tool to aid informed consent about palliative radiation therapy; and (2) after the patient watches the video educational tool. (3) If the patient receives PRT, a final questionnaire that assesses the patient's impression of the video will also be administered at the conclusion of radiation therapy.

questionnaires

Beryl McCormack, MD

The purpose of this study is to assess the effectiveness and acceptability of a recently created informative video geared for patients who have been evaluated by a radiation oncologist for palliative radiation therapy during a hospitalization at Memorial Sloan-Kettering Cancer Center. Palliative radiation therapy is radiation therapy that is given to patients with the purpose of easing symptoms from cancer. It is not given with the intent to cure the cancer. The video presents basic information about palliative radiation and palliative care.

Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy

Effectiveness of the video tool will be assessed by the following measures before and after watching the video. The pre- and post-assessment design comparing uncertainty, knowledge and preference scores of a video explaining palliative radiation and palliative care.

Memorial Sloan Kettering Cancer Center

Hormones

Immunomodulating Agents

Hormone Antagonists

Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.

Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.

Investigators should follow the principles of palliative radiotherapy as per the individual institution in order to alleviate symptoms or prevent complications. If radiotherapy is indicated, recommended doses are 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

Palliative Radiation

Chemotherapy

Immunotherapy

Observation only is acceptable if this is the standard practice.

Observation

Total dose of radiation and number of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every 2 days), or 35 Gy in 5 fractions (daily).

Stereotactic Ablative Radiotherapy

David Palma, MD

Suresh Senan, MRCP, FRCR

Robert Olson, MD

Stephen Harrow, MB ChB

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

Time from randomization to death from any cause.

Time from randomization to disease progression at any site or death.

New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.

Amsterdam University Medical Centre, VUmc Site

British Columbia Cancer - Centre for the North

Beaston West of Scotland Cancer Centre

London Health Sciences Centre

David Palma

Principal Investigator

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Analgesics

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Immunoglobulins

Interleukin-2

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.

In subsequent cycles participants will receive NKTR-214 and anti-PD-1.

Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)

NKTR-214

anti-PD-1 therapy

Zachary Morris, MD, PhD

Paul Harari, MD

Adam Burr, MD, PhD

Justine Bruce, MD

This trial will evaluate safety and efficacy of the combination of anti-PD1, NKTR-214, and palliative radiation therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Twenty-four participants will be enrolled to evaluate the efficacy of this combination.

Following an informed consent process, participants will receive anti-PD-1 therapy with 200 mg of pembrolizumab and NKTR-214 at 0.006 mg/kg. Palliative radiation therapy will then be delivered to tumor sites causing or felt by the treating physician to have a high potential for causing symptoms with either 8 Gy X 3 or 4 Gy X 5 completed 3 to 7 days prior to cycle 2 of anti-PD1 and NKTR-214. Combined anti-PD-1 and NKTR-214 will then be delivered each subsequent cycle.

Efficacy will be measured by overall response rate (ORR), progression free survival (PFS), overall survival (OS), clinical benefit (CB), and duration of response with ORR the primary outcome being compared to historical control data. Toxicity will be evaluated prior to administration of each 21-day cycle, while receiving NKTR-214 followed by every four months after the participant is off trial. Health related quality of life questionnaires will be completed with cycle 1 and 2 and then every 4 cycles thereafter.

Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma

Phase II Study of Bempegaldesleukin (NKTR-214) Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

PD-L1 expression has been shown to predict response to immunotherapy regimens. If PD-L1 expression correlates with outcome, it could be used in the future to select patients who have greatest benefit from this regimen.

Evaluation of the in vivo immune response will help better define the mechanism of action of this combination therapy.

ORR is the percentage of participants whose cancer shrinks or disappears after treatment. ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST1.1, by investigator assessment.

Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not "unrelated" to treatment, will be considered treatment-related. Adverse events are evaluated by the physician graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.

Toxicities ≥ Grade 3 is defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicities not "unrelated" to treatment, will be considered treatment-related. Adverse events are evaluated by the physician and graded from 1-5 where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death.

PFS is the average length of time after the start of treatment in which a person is alive, and their cancer does not grow or spread. PFS is defined as the time from day 1 of treatment until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause.

OS is defined as time from day 1 of treatment until death as a result of any cause.

CB will include confirmed complete response (CR) + confirmed partial response (PR) + stable disease at ≥ 6 months (SD) and will be determined as per RECIST1.1.

Duration of response is the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented.

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher global or functional scores indicate increased quality of life and higher symptom scores indicate increased symptoms: Global health status (QL2), Physical functioning (PF2), Role functioning (RF2), Emotional functioning (EF), Cognitive functioning (CF), and Social functioning (SF).

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a measure of health-related quality of life for cancer patients participating in clinical trials. It scores the following domains from 0-100 where higher symptom scores indicate increased symptoms: Fatigue (FA), Nausea and vomiting (NV), Pain (PA), Dyspnea (DY), Insomnia (SL), Appetite loss (AP), Constipation (CO), Diarrhea (DI), Financial difficulties (FI)

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire - Head and Neck (EORTC QLQ-H\&N35) is comprised of the following subscales, scored from 0-100 where higher scores indicate increased symptoms: Pain (HNPA), Swallowing (HNSW), Senses problem (HNSE), Speech problems (HNSP), Trouble with social eating (HNSO), Trouble with social contact (HNSC), Less sexuality (HNSX), Teeth (HNTE), Opening mouth (HNOM), Dry mouth (HNDR), Sticky saliva (HNSS), Coughing (HNCO), Felt ill (HNFI), pain killers (HNPK), Nutritional supplements (HNNU), Feeding tube (HNFE), Weight loss (HNFL), Weight gain (HNWG)

The EQ-5D is a 5 question measure of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus an overall measure of health reported on a visual analog scale. Participant counts are reported for each of 5 dimensions: mobility, self-care, usual activities, pain / discomfort, anxiety / depression.

Nektar Therapeutics

University of Wisconsin, Madison

Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.

In subsequent cycles participants will receive NKTR-214 and anti-PD-1.

NKTR-214: Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)

anti-PD-1 therapy: immunotherapy drug, monoclonal antibody

Palliative Radiation: radiation to relieve symptoms

NKTR-214, Anti-PD Therapy Plus Palliative Radiation

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Objective Response Rate (ORR)

Number of Participants With Adverse Events Greater Than or Equal to Grade 3

Weight Loss

Dry Mouth

Sepsis

Skin Ulceration

Thrush

Lymphocyte Count Decreased

Hyperthyroidism

Hypoalbuminemia

Hyponatremia

Hypercalcemia

Total Grade 3 Adverse Events Among 5 Patients Evaluable for Toxicity

Grade 3

Total Grade 4 Adverse Events Among 5 Patients Evaluable for Toxicity

Grade 4

Total Grade 5 Adverse Events Among 5 Patients Evaluable for Toxicity

Grade 5

Summary of Adverse Events Greater Than or Equal to Grade 3 by Count of Participants Who Experienced Them

Progression Free Survival (PFS)

Overall Survival (OS)

Number of Participants With Clinical Benefit (CB)

Duration of Response

EORTC QLQ-C30: Global and Functional Sub-Scores prior to treatment

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (Screening)

Cycle 1 consists of anti-PD-1 therapy (200mg) and NKTR-214 (0.006 mg/kg3 administered intravenously), followed by palliative radiation (8 Gy x 3 or 4 Gy x 5 fractions) combined with anti-PD-1 therapy and NKTR-214 in cycle 2.

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C1D8)

Participants will receive NKTR-214 and anti-PD-1. Palliative Radiation: radiation to relieve symptoms.

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C2D8)

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (C3D8)

EORTC QLQ-C30: Global and Functional Sub-Scores Post Treatment

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30-day Post)

Health Related Quality of Life as Measured by EORTC QLQ-C30: Global and Functional Sub-Scores

EORTC QLQ-C30: Symptom Sub-Scores prior to treatment

EORTC QLQ-C30: Symptom Sub-Scores Post Treatment

Health Related Quality of Life as Measured by EORTC QLQ-C30: Symptom Sub-Scores

HNPA

HNSW

HNSE

HNSP

HNSO

HNSC

HNSX

HNTE

HNOM

HNDR

HNSS

HNCO

HNFI

HNPK

HNNU

HNFE

HNWL

HNWG

EORTC QLQ-H\&N35 Sub-Scores prior to treatment

EORTC QLQ-H\&N35 Sub-Scores Post Treatment

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (30 Days Post)

Health Related Quality of Life as Measured by EORTC QLQ-H&N35 Sub-Scores

MOBILITY

SELF-CARE

USUAL ACTIVITIES

PAIN / DISCOMFORT

ANXIETY / DEPRESSION

EQ-5D Participant Counts prior to treatment

NKTR-214, Anti-PD Therapy Plus Palliative Radiation (Baseline)

EQ-5D Participant Counts 30 days post treatment

Health Related Quality of Life as Measured by EQ-5D Participant Counts

Expression of PD-L1 by Histology

Levels of IFN-γ Expressing and CD122+ T Cells in Peripheral Blood Mononuclear Cells (PBMC)

Diversity and Clonality of the T Cell Receptor Repertoire by Deep Sequencing of PBMC

Levels of Tumor Infiltrating Lymphocytes by Histology

Overall Study

Patients in the standard arm will receive a conventional radiotherapy dose will be either 30 gray (Gy) in 10 fraction or 20Gy in 5 fractions. Patients will be stratified by intended dose prior to randomization. Radiation for patients in the standard arm should adhere to the principles of palliative radiation, with goals of alleviating symptoms or preventing potential complications.

Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.

Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.

Conventional radiotherapy

Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.

Esophageal-Sparing Intensity-Modulated Radiotherapy

A randomized phase II study of palliative radiation of advanced central lung tumors with intentional avoidance of the esophagus. Patients will be randomized between standard of care palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 1 year after completion of their radiation therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).

A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus

Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.

Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test.

Differences in local/regional progression-free survival will be tested using the stratified log-rank test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)	NCT00391248	Non-small Cell ...	Erlotinib	18 Years -	Ontario Clinical Oncology Group (OCOG)
Use of a Video Decision Tool to Improve Informed Decision-Making in Hospitalized Patients Considering Palliative Radiation Therapy	NCT01667965	Metastatic Canc... Patients Receiv...	questionnaires	18 Years -	Memorial Sloan Kettering Cancer Center
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors	NCT03721341	Metastatic Tumo...	Palliative Radi... Chemotherapy Immunotherapy Hormones Observation Stereotactic Ab...	18 Years -	Lawson Health Research Institute
Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma	NCT04936841	Head and Neck C...	NKTR-214 anti-PD-1 thera... Palliative Radi...	18 Years -	University of Wisconsin, Madison
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus	NCT02752126	Non-Small Cell ...	Conventional ra... Esophageal-Spar...	18 Years -	Lawson Health Research Institute
Prospective Validation of a Points Score System Predicting 30-day Survival	NCT05100342	Metastatic Canc...	Point score pre...	18 Years -	Indiana University
Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain	NCT03523351	Metastatic Soli...	Radiation Thera... Systemic Therap...	18 Years -	Memorial Sloan Kettering Cancer Center

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