Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-07

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will test the safety of Quad Shot radiation therapy using 2 different treatment schedules to find out what effects, if any, this treatment has on people with advanced NSCLC who are receiving systemic therapy for their cancer. The Quad Shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

NCT00002484

Lung Cancer

COMPLETED PHASE1

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

NCT01055197

Lung Cancer

COMPLETED PHASE2

Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

NCT04073745

Lung Non-Small Cell Carcinoma Positive Surgical Margin Resected Mass +7 more

ACTIVE_NOT_RECRUITING PHASE1

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

NCT00057746

Lung Cancer

COMPLETED PHASE2

Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

NCT00002577

Lung Cancer

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Phase I, prospective trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quad Shot Radiation

In this trial, patients with centrally located lung tumors will be treated with up to 3 cycles of Quad Shot Radiation. Radiation treatment will be given within 1 week of administration of chemotherapy. Quad Shot radiation will involve: 3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break. The first group of patients will be treated with 2 cycles of quad shot radiation, followed by a 3-month observation period post-RT to allow a complete evaluation of acute toxicity. The next group of patients will be treated with either 1 cycle or 3 cycles of quad shot radiation. The minimum accrual is 4 patients with an expected accrual of 16 patients. Twenty additional patients will be recruited to an expansion cohort.

Group Type EXPERIMENTAL

Cyclical Hypofractionated Palliative Radiation (Quad Shot)

Intervention Type RADIATION

3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break.

EORTC QLQ-C30 questionnaire

Intervention Type BEHAVIORAL

at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclical Hypofractionated Palliative Radiation (Quad Shot)

3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break.

Intervention Type RADIATION

EORTC QLQ-C30 questionnaire

at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies:

* Carboplatin/paclitaxel
* Carboplatin/paclitaxel/pembrolizumab
* Carboplatin/pemetrexed
* Carboplatin/pemetrexed/pembrolizumab
* Pembrolizumab (single agent or in combination with other regimens in this list)
* Cisplatin/pemetrexed
* Cisplatin/pemetrexed/pembrolizumab
* Pemetrexed/pembrolizumab
* Pemetrexed
* Nivolumab (single agent or in combination with other regimens in this list)
* Ipilimumab/nivolumab
* Carboplatin/etoposide
* Carboplatin/etoposide/atezolizumab
* Cisplatin/etoposide
* Cisplatin/etoposide/atezolizumab
* Durvalumab (single agent or in combination with other regimens in this list)
* Atezolizumab (single agent or in combination with other regimens in this list)
* Patients eligible for the systemic therapy regimens notes
* Patients with Stage IV NSCLC who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located.
* KPS ≥ 60
* Age ≥ 18 years.
* Able to provide informed consent.
* Patients at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria

* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
* Serious medical co-morbidities precluding radiotherapy.
* Pregnant or breast-feeding women.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No