N/A
Completed N=42
Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
Malignant Non-small Cell Neoplasm of Lung Stage Ia
Source: ClinicalTrials.gov NCT01841060 ↗
Enrolled (actual)
42
Serious AEs
4.8%
Results posted
Jan 2021
Primary outcomePrimary: Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA) — 5 Participants
Summary
Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA) |
5 | — |
| SECONDARY Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA) |
3 | — |
| SECONDARY 1-year Overall Survival (OS) Rate |
33 | — |
| SECONDARY 3-year Overall Survival (OS) Rate |
21 | — |
Eligibility Criteria
Inclusion criteria
- Patients over 18 years
- Histological diagnosis of non-small cell lung tumor established.
- Stage 1A tumors (lesions = 2.5) at the lesion to be treated,
- Signed informed consent,
- Patient affiliated to a social security scheme.
Exclusion criteria
- Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)
- Disorder of uncontrolled bleeding (TP 1.5 x control).
- Abnormal blood count platelets <90000/mm3
- Cons-indication to general anesthesia
- Patient with a cardiac pacemaker if a review indicates treatment against ARF
- pregnancy
- Patient included in another clinical study
- Unable to undergo medical monitoring test for geographical, social or psychological reasons,
- Private patient freedom and major subject of a measure of legal protection or unable to consent.
Data sourced from ClinicalTrials.gov (NCT01841060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.