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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 belowSelect...
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.
Select...
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.
Select...
I have chosen not to undergo surgery for my condition.
ARTIA-Lung Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to 30 days after completion of chemoradiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to 30 days after completion of chemoradiotherapy
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 moreSide effects data
From 2014 Phase 4 trial • 45 Patients • NCT0200053129%
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- If there are big issues with the pictures that make it hard to see the chest and tumors clearly, you might not be able to join the study. For example, if you have a medical device near the area being looked at, it might cause problems with the pictures.My cancer can be measured by tests.I do not have severe COPD or other lung problems that would stop me from receiving the study treatment.My organs and bone marrow are functioning normally.I had a PET-CT scan within the last 2 months.I had a physical exam within the last 30 days.My tests show cancer cells in the fluid around my lungs.My cancer is stage IIIC with specific lymph node involvement.I haven't been hospitalized for lung issues other than my cancer in the last year.My cancer is at stage IIIA-IIIB.My treatment team has decided that surgery is not an option for me.I am a woman who can have children and I am not using birth control.You have had a brain MRI or contrast enhanced CT scan within the last 60 days before joining the study.My kidney function test shows creatinine is 1.5 mg/dL or less.My lung cancer has been confirmed through tissue examination.I can care for myself and am considered fit for chemoradiotherapy.I am 18 years old or older.I have severe difficulty breathing, coughing, or swallowing.I have chosen not to undergo surgery for my condition.My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.I have had radiation therapy to my chest area before.I have been cancer-free from a non-skin cancer for at least 3 years.Women who can have children must have a negative pregnancy test within 14 days before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive Arm
- Group 2: Non-Adaptive Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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