Phase I study of Continuous Hyperfractionated Accelerated RadioTherapy - Escalated Dose

Phase 1

Completed

• Conditions: on-small cell lung cancer (NSCLC); Malignant neoplasm of bronchus and lung; Cancer

• Registration Number: ISRCTN45918260
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Brief Summary

2016 Results article in https://pubmed.ncbi.nlm.nih.gov/26687902 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-03
• Study Completion: 2011-09-01
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Queries about inclusion criteria should be addressed prior to entry into the study. Patients are eligible for the study if all of the following criteria are met:
1. Histologically or cytologically confirmed stage III NSCLC
2. World Health Organization (WHO) performance status 0 or 1
3. Life expectancy greater than 6 months
4. Inoperable disease as assessed by a Lung Cancer Multi-Disciplinary Team (MDT) with input from Thoracic Surgeon; or operable but the patient refuses surgery
5. Aged 18 or over (no upper age limit), either sex
6. No prior thoracic radiotherapy
7. No prior lobectomy/pneumonectomy
8. No prior systemic chemotherapy
9. Willing and able to give informed consent
10. Adequate pulmonary function test (PFT) results: forced expiratory volume in one second (FEV1) and/or carbon monoxide transfer factor (DCLO) greater than or equal to 40% of predicted
11. For women with childbearing potential:
11.1. Negative pregnancy test
11.2. Adequate contraceptive precautions

Exclusion Criteria

Patients are ineligible for the trial if any of the following criteria are met:
1. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
2. Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, cardiovascular disease such as congestive cardiac failure)
3. Previous diagnosis of interstitial lung disease
4. Previous diagnosis of spinal cord disease
5. Women of childbearing potential who are not practicing adequate contraceptive precautions
6. Women who are pregnant or lactating
7. Connective tissue disorders (e.g. scleroderma, systemic lupus erythematosus)

Study & Design

• Study Type: Interventional
• Study Design: Not specified