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Radiation Therapy

Adaptive Radiation Therapy for Stage III Lung Cancer (ARTIA-Lung Trial)

N/A
Waitlist Available
Led By Dennis Stanley, PhD
Research Sponsored by Varian, a Siemens Healthineers Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease must be present
Clinical stage IIIC due to contralateral mediastinal lymph node involvement only (e.g., no contralateral hilar or any supraclavicular/cervical lymph node metastases). Mediastinal stations 2R and 4R are considered contralateral for patients whose primary tumor is within the left lung. Mediastinal stations 2L, 4L, 5, and 6 are considered contralateral for patients whose primary tumor is in the right lung
Must not have
Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy
Evidence of malignant pleural effusion, defined as either FDG PET avidity within effusion fluid or presence of malignant cells identified by cytology of thoracentesis fluid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 30 days after completion of chemoradiotherapy
Awards & highlights

Summary

This trial will compare two types of radiation therapy for stage III non-small cell lung cancer to see which one causes less toxicity.

Who is the study for?
This trial is for adults over 18 with stage IIIA-IIIB non-small cell lung cancer (NSCLC) who are not candidates for surgery. Participants must have no distant metastases, normal organ and marrow function, and an ECOG performance status of 0-2. They should not have had previous thoracic radiation or other cancers within the last three years.Check my eligibility
What is being tested?
The study compares daily online adaptive radiotherapy combined with chemotherapy against standard non-adaptive radiotherapy with chemotherapy in treating stage III NSCLC. The goal is to see if the adaptive method reduces acute respiratory and esophageal toxicity one month post-treatment.See study design
What are the potential side effects?
Potential side effects include acute respiratory issues like coughing or difficulty breathing, as well as esophageal problems such as pain when swallowing. These will be measured using patient-reported outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by tests.
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My cancer is stage IIIC with specific lymph node involvement.
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My organs and bone marrow are functioning normally.
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I had a PET-CT scan within the last 2 months.
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My cancer is at stage IIIA-IIIB.
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My treatment team has decided that surgery is not an option for me.
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My kidney function test shows creatinine is 1.5 mg/dL or less.
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My lung cancer has been confirmed through tissue examination.
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I can care for myself and am considered fit for chemoradiotherapy.
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I have chosen not to undergo surgery for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe COPD or other lung problems that would stop me from receiving the study treatment.
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My tests show cancer cells in the fluid around my lungs.
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I haven't been hospitalized for lung issues other than my cancer in the last year.
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I am a woman who can have children and I am not using birth control.
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I have severe difficulty breathing, coughing, or swallowing.
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My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.
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I have had radiation therapy to my chest area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 30 days after completion of chemoradiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 30 days after completion of chemoradiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute toxicity
Secondary outcome measures
Global quality of life
Local progression
Lung cancer specific quality of life
+4 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adaptive ArmExperimental Treatment3 Interventions
Subjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
Group II: Non-Adaptive ArmActive Control3 Interventions
Subjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immunotherapy
2016
Completed Phase 4
~1470
Adaptive Radiotherapy
2007
Completed Phase 2
~160
Chemotherapy
2003
Completed Phase 4
~3050

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, which kills rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in cancer growth and spread; immunotherapy, which boosts the body's immune system to fight cancer; and radiotherapy, which uses high-energy radiation to destroy cancer cells. Daily Online Adaptive Radiotherapy, a form of radiotherapy, adjusts the radiation treatment plan based on daily imaging to better target the tumor and spare normal tissues. This approach is particularly important for NSCLC patients as it can reduce acute respiratory and esophageal toxicity, improving the overall safety and effectiveness of the treatment.

Find a Location

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor
30 Previous Clinical Trials
7,009 Total Patients Enrolled
Dennis Stanley, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Andrew McDonald, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Adaptive Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05488626 — N/A
Non-Small Cell Lung Cancer Research Study Groups: Adaptive Arm, Non-Adaptive Arm
Non-Small Cell Lung Cancer Clinical Trial 2023: Adaptive Radiotherapy Highlights & Side Effects. Trial Name: NCT05488626 — N/A
Adaptive Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488626 — N/A
~39 spots leftby Dec 2024