Clinical trial · Interventional
A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy
A Phase III, Multi-centre, Randomized Trial to Evaluate the Symptomatic and Quality of Life Improvements in Lung Cancer Patients Receiving External Beam Radiation With or Without High Dose Rate Intraluminal Brachytherapy
NCT01351116CI-TRIAL-00025593BRACHYcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBR | Radiation | — | UNRESOLVED |
| EBR plus HDRIB | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EBR plus HDRIB
- description
- External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB)
- interventionNames
- Radiation: EBR plus HDRIB
- type
- ACTIVE_COMPARATOR
- label
- EBR
- description
- External Beam Radiation (EBR)
- interventionNames
- Radiation: EBR
Primary outcomes (1)
- measure
- For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologic or histologic proof of non-small cell lung cancer (NSCLC) * Stages III, IV or recurrent disease * Documented endobronchial luminal disease by either endoscopy or CT-imaging * Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis Exclusion Criteria: * Age less than 18 years of age * Uncontrolled or symptomatic brain metastases * Anticipated survival of less than 3 months * Systemic therapy planned to begin within 6 weeks following randomization * Systemic therapy within 4 weeks of planned study randomization * Any prior radiotherapy involving the lungs * Cardiac arrest or myocardial infarction within 6 months prior to study randomization * Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB * Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women * Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial * Having received an investigational agent within one month of study randomization * Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility
References
Publications (0)
Data not yet available
No reference posted for this study.