Clinical trial · Interventional
Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
NCT00346320CI-TRIAL-00068571completedN/AClinicalTrials.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)
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- 3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
- interventionNames
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
- Local tumor control rate at 2 years
- timeFrame
- 2 years
- description
- Overall tumor control rate will be assessed at 6 years
Secondary outcomes (6)
- measure
- Toxicity
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage I or II peripheral disease
* T1, N0, M0
* T2 (≤ 5 cm), N0, M0
* T3 (≤ 5 cm, chest wall primary tumor only), N0, M0
* No T2-T3 primary tumors \> 5 cm or any T1-T3 tumor of the mainstem bronchus involvement
* No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)
* Hilar or mediastinal lymph nodes ≤ 1 cm considered N0
* Any of the following primary cancer types:
* Squamous cell carcinoma
* Adenocarcinoma
* Large cell carcinoma
* Bronchioloalveolar cell carcinoma
* Non-small cell carcinoma not otherwise specified
* Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)
* Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed
* If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen
* Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs
* No ataxia telangiectasia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)
* No active systemic, pulmonary, or pericardial infection
* No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.
* Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy to the area of the primary tumor
* No prior or concurrent chemotherapy or immunotherapy for this tumorReferences
Publications (1)
- RESULTCheung P, Faria S, Ahmed S, Chabot P, Greenland J, Kurien E, Mohamed I, Wright JR, Hollenhorst H, de Metz C, Campbell H, Vu TT, Karvat A, Wai ES, Ung YC, Goss G, Shepherd FA, O'Brien P, Ding K, O'Callaghan C. Phase II study of accelerated hypofractionated three-dimensional conformal radiotherapy for stage T1-3 N0 M0 non-small cell lung cancer: NCIC CTG BR.25. J Natl Cancer Inst. 2014 Jul 29;106(8):dju164. doi: 10.1093/jnci/dju164. Print 2014 Aug. PMID 25074417