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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 30 days after completion of chemoradiotherapy
Awards & highlights

ARTIA-Lung Trial 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.

ARTIA-Lung Trial 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.

ARTIA-Lung Trial 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

ARTIA-Lung 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
Adaptive Radiotherapy
2007
Completed Phase 2
~160
Immunotherapy
2016
Completed Phase 4
~1270
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor
30 Previous Clinical Trials
7,029 Total Patients Enrolled
Dennis Stanley, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Andrew McDonald, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
59 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size for this clinical investigation?

"Indeed, according to information listed on clinicaltrials.gov, recruitment for this investigation is currently underway. It was initially published in October 2020 and edited shortly thereafter. This research seeks a total of 244 participants from one medical centre."

Answered by AI

Is this research experiment open to recruitment at the moment?

"According to clinicaltrials.gov, this medical trial is presently looking for individuals suitable to participate in the study. It was first made available on October 20th 2022 and has been recently edited as of October 21st 2022."

Answered by AI
~68 spots leftby Dec 2024