Clinical trial · Interventional
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
NCT00009789CI-TRIAL-00023044completedPhase 1ClinicalTrials.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: Specialized 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: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
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 |
|---|---|---|---|
| accelerated conformational radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
- interventionNames
- Radiation: accelerated conformational radiotherapy
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Up to 5 years
- measure
- Failure-free survival
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
* Squamous cell carcinoma
* Basaloid carcinoma
* Adenocarcinoma
* Bronchoalveolar carcinoma
* Adenosquamous carcinoma
* Large cell carcinoma
* Large cell neuroendocrine carcinoma
* Giant cell carcinoma
* Sarcomatoid carcinoma
* Non-small cell carcinoma not otherwise specified
* Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
* No metastatic disease or hilar or mediastinal lymphadenopathy
* Must have mediastinoscopy\* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
* No positive lymph nodes on mediastinoscopy\* NOTE: \*Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
* Poor surgical risk, as defined by 1 of the following:
* High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
* Pulmonary dysfunction indicated by one or more of the following:
* FEV\_1 less than 40% of predicted
* DLCO less than 50% of predicted
* Oxygen dependent
* Chronic PaCO\_2 greater than 45 mm Hg
* VO\_2 less than 15 mL/kg/min
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* 0-2
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No weight loss of more than 10% within the past 6 months
* No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
Chemotherapy:
* No prior chemotherapy for NSCLC
Radiotherapy:
* No prior chest radiotherapyReferences
Publications (1)
- RESULTBogart JA, Hodgson L, Seagren SL, Blackstock AW, Wang X, Lenox R, Turrisi AT 3rd, Reilly J, Gajra A, Vokes EE, Green MR. Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904. J Clin Oncol. 2010 Jan 10;28(2):202-6. doi: 10.1200/JCO.2009.25.0753. Epub 2009 Nov 23. PMID 19933904