ARTIA-Lung: Daily Adaptive Radiation Therapy: An Individualized Approach for Stage III Lung Cancer
Study Details
Study Description
Brief Summary
This is a prospective multi-center randomized clinical trial designed to demonstrate that daily online adaptive radiotherapy with concomitant chemotherapy for stage III non-small cell lung cancer (NSCLC) will result in decreased acute respiratory and esophageal toxicity compared with non-adaptive radiotherapy with concomitant chemotherapy. The timepoint for this assessment will be 1 month following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adaptive Arm 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. |
Device: Adaptive Radiotherapy
Standard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily online adaptation.
Drug: Chemotherapy
Concomitant chemotherapy per NCCN or other national guidelines.
Drug: Immunotherapy
Adjuvant immunotherapy per national or institutional guidelines.
|
| Active Comparator: Non-Adaptive Arm 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. |
Device: Non-Adaptive Radiotherapy
Standard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily image guidance.
Drug: Chemotherapy
Concomitant chemotherapy per NCCN or other national guidelines.
Drug: Immunotherapy
Adjuvant immunotherapy per national or institutional guidelines.
|
Outcome Measures
Primary Outcome Measures
- Acute toxicity [From randomization to 30 days after completion of chemoradiotherapy]
Composite rate of grade 3 or worse cough, dyspnea, or dysphagia using PRO-CTCAE
Secondary Outcome Measures
- Lung cancer specific quality of life [From randomization to 12 months after completion of chemoradiotherapy]
Results from the FACT-L questionnaire
- Global quality of life [From randomization to 12 months after completion of chemoradiotherapy]
Results from the EQ-5D-5L questionnaire
- Normal lung tissue radiation exposure [End of external beam radiation treatment (approximately 2 months from randomization)]
The percentage of normal lung tissue volume that receives radiation of 20 Gy or more over the course of radiation treatment.
- Mean normal tissue doses [End of external beam radiation treatment (approximately 2 months from randomization)]
Mean dose delivered to the heart, esophagus and normal lung tissue over the course of radiation treatment.
- Overall response rate [3 months, 6 months and 12 months after completion of chemoradiotherapy]
Frequency of complete and partial tumor response as determined on chest imaging using RECIST v1.1
- Local progression [12 months after completion of chemoradiotherapy]
Physician report of progression determined by imaging or clinical evaluation
- Radiation pneumonitis [12 months after completion of chemoradiotherapy]
CTCAE v.5.0 grade 2+ pneumonitis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form.
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Histologically confirmed NSCLC
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Clinical stage IIIA-IIIB (AJCC v8) disease who are either:
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Patients classified as non-operable by the treatment team
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Patients who refuse surgery
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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.
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Completed evaluation for metastatic disease with no distant metastases identified.
Evaluation must include the following:
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History and physical examination within 30 days prior to enrollment.
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Whole body FDG PET-CT for staging within 60 days prior to enrollment
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Brain MRI or contrast enhanced CT within 60 days prior to enrollment.
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ECOG performance status 0-2 and deemed clinically fit for chemoradiotherapy.
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Age ≥18 years (or at least the local age of consent)
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Patients must have normal organ and marrow function.
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Serum creatinine ≤1.5 mg/dL within 60 days prior to enrollment.
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Measurable disease must be present.
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Negative urine or serum pregnancy test within 14 days prior to enrollment for women of childbearing potential.
Exclusion Criteria:
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Contralateral hilar or any supraclavicular/cervical lymph nodes.
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Baseline grade ≥3 dyspnea, or cough, or dysphagia.
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Prior invasive non-skin malignancy unless disease free for a minimum of 3 years.
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History of prior RT to the thorax.
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Severe imaging artifact that, in the view of the local investigator, would preclude accurate identification of the thoracic anatomy and tumor targets on the cone beam CT (e.g., artifact created implanted cardiac device in proximity to the targets).
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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.
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Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy.
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Hospitalization for chronic obstructive pulmonary disease or respiratory illness other than NSCLC within 1 year prior to study enrollment.
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Women of childbearing potential and sexually active women not willing or able to use contraception.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- Varian, a Siemens Healthineers Company
Investigators
- Principal Investigator: Andrew McDonald, MD, University of Alabama at Birmingham
- Principal Investigator: Dennis Stanley, PhD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAR-2021-09