Quality of life after radiotherapy treatment for patients with non-small cell lung cancer

Not Applicable

• Conditions: Stage IV non-small cell lung cancer; Cancer

• Registration Number: ISRCTN52137148
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-19
• Last Update Posted: 2 September 2024
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

1. =16 years of age
2. Stage IV NSCLC (radiological diagnosis confirmed at MDT as a minimum)
3. Thoracic disease amenable to radiotherapy
4. Provision of written informed consent
5. For women of childbearing potential: a negative urine or serum pregnancy test within 7 days prior to the randomisation
6. Patients not having systemic treatment
7. ECOG Performance Status 0-3
8. At least T2 and/or N1 disease
9. Fit to receive low-dose palliative radiotherapy according to local guidelines and assessment

Exclusion Criteria

1. The need for palliative radiotherapy to the thorax prior to randomisation
2. Comorbidities which are considered a contraindication to radiotherapy by the treating clinical team, including interstitial lung disease and active connective tissue disorders
3. History of prior malignant tumours likely to interfere with the protocol treatment or comparisons
4. Leptomeningeal disease
5. Women who are pregnant or breastfeeding
6. Women of child-bearing potential who are not able or unwilling to use a highly effective method of contraception
7. Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol
8. Patients receiving systemic therapy for NSCLC
9. Prior treatments for this NSCLC
10. Patients participating in a clinical trial of an investigational medicinal product

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health utility measured using EORTC QLU-C10D Area Under the Curve (AUC; using trapezoidal rule) to derive a health utility score per year. Questionnaire completed: Screening/Baseline, week 0-2, week 3, week 4, week 5, week 6, week 8, month 3, month 4, month 5, month 6.

Secondary Outcome Measures

Name	Time	Method
1. Overall survival - Defined as time from randomisation to death from any cause. Censored at the last follow-up if event-free.<br>2. Quality of life using EORTC QLQ-C30 and EQ-5D-5L. Questionnaires completed: Screening/Baseline, month 3, month 6.<br>3. Lung cancer symptoms using EORTC QLQ-LC13. Questionnaires completed: Screening/Baseline, month 3, month 6.<br>4. Acute and late toxicity as assessed NCI CTCAE v5.0. From informed consent to end of study. <br>