Clinical trial NCT05488626: Daily Adaptive Radiation Therapy: An Individualized Approach for Stage III Lung Cancer
Official title: Daily Adaptive vs Non-Adaptive External Beam Radiation Therapy With Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Trial of an Individualized Approach for Toxicity Reduction (ARTIA-Lung)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stage III Non-small Cell Lung Cancer
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 3 months following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Histologically confirmed NSCLC
3. Clinical stage IIIA-IIIB (AJCC v8) disease who are either:

   1. Patients classified as non-operable by the treatment team
   2. Patients who refuse surgery
4. 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.
5. Completed evaluation for metastatic disease with no distant metastases identified. Evaluation must include the following:

   1. History and physical examination within 30 days prior to enrollment.
   2. Whole body FDG PET-CT for staging within 60 days prior to enrollment
   3. Brain MRI or contrast enhanced CT within 60 days prior to enrollment.
6. ECOG performance status 0-2 and deemed clinically fit for chemoradiotherapy.
7. Age ≥18 years (or at least the local age of consent)
8. Patients must have normal organ and marrow function.
9. Serum creatinine ≤1.5 mg/dL within 60 days prior to enrollment.
10. Measurable disease must be present.
11. Negative urine or serum pregnancy test within 14 days prior to enrollment for women of childbearing potential.

Exclusion Criteria:

1. Contralateral hilar or any supraclavicular/cervical lymph nodes.
2. Baseline grade ≥3 dyspnea, or cough, or dysphagia.
3. Prior invasive non-skin malignancy unless disease free for a minimum of 3 years.
4. History of prior RT to the thorax.
5. 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).
6. 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.
7. Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy.
8. Hospitalization for chronic obstructive pulmonary disease or respiratory illness other than NSCLC within 1 year prior to study enrollment.
9. Women of childbearing potential and sexually active women not willing or able to use contraception.

Primary outcomes:
measure: Acute toxicity
timeFrame: From randomization to 90 days after completion of chemoradiotherapy
Secondary outcomes:
measure: Lung cancer specific quality of life
timeFrame: From randomization to 12 months after completion of chemoradiotherapy
measure: Global quality of life
timeFrame: From randomization to 12 months after completion of chemoradiotherapy
measure: Normal lung tissue radiation exposure
timeFrame: End of external beam radiation treatment (approximately 2 months from randomization)
measure: Mean normal tissue doses
timeFrame: End of external beam radiation treatment (approximately 2 months from randomization)
measure: Overall response rate
timeFrame: 3 months, 6 months and 12 months after completion of chemoradiotherapy
measure: Local progression
timeFrame: 12 months after completion of chemoradiotherapy
measure: Radiation pneumonitis
timeFrame: 12 months after completion of chemoradiotherapy
measure: Healthcare resource utilization
timeFrame: From the start of radiation treatment to 12 months after completion of chemoradiotherapy.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrew McDonald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Dennis Stanley, PhD
role: PRINCIPAL_INVESTIGATOR
References: