Daily Adaptive Radiation Therapy: An Individualized Approach for Stage III Lung Cancer

Stage III Non-small Cell Lung Cancer Clinical Trial

— ARTIA-Lung  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05488626
• Other study ID #: VAR-2021-09
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Varian, a Siemens Healthineers Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 244
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage III Non-small Cell Lung Cancer

Intervention

Device:
• Adaptive Radiotherapy
Standard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily online adaptation.
• 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.
• Immunotherapy
Adjuvant immunotherapy per national or institutional guidelines.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity	Composite rate of grade 3 or worse cough, dyspnea, or dysphagia using PRO-CTCAE	From randomization to 30 days after completion of chemoradiotherapy
Secondary	Lung cancer specific quality of life	Results from the FACT-L questionnaire	From randomization to 12 months after completion of chemoradiotherapy
Secondary	Global quality of life	Results from the EQ-5D-5L questionnaire	From randomization to 12 months after completion of chemoradiotherapy
Secondary	Normal lung tissue radiation exposure	The percentage of normal lung tissue volume that receives radiation of 20 Gy or more over the course of radiation treatment.	End of external beam radiation treatment (approximately 2 months from randomization)
Secondary	Mean normal tissue doses	Mean dose delivered to the heart, esophagus and normal lung tissue over the course of radiation treatment.	End of external beam radiation treatment (approximately 2 months from randomization)
Secondary	Overall response rate	Frequency of complete and partial tumor response as determined on chest imaging using RECIST v1.1	3 months, 6 months and 12 months after completion of chemoradiotherapy
Secondary	Local progression	Physician report of progression determined by imaging or clinical evaluation	12 months after completion of chemoradiotherapy
Secondary	Radiation pneumonitis	CTCAE v.5.0 grade 2+ pneumonitis	12 months after completion of chemoradiotherapy