Clinical trial · Interventional
Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer
NCT01222572CI-TRIAL-00018143terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual due to restrictive eligibility criteria
Summary
Brief summary (as posted)
In this research study the investigators are looking for the highest dose of a stereotactic radiation boost that can be given safely. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects the participant experiences; the goal is to improve the likelihood of killing the tumor.
Conditions
Conditions (3)
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 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Stereotactic Boost to Chemoradiotherapy (Dose Level 1)
- description
- Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy \- Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point.
- interventionNames
- Radiation: Stereotactic boost
- Radiation: Conventional RT
- Drug: Etoposide
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Stereotactic Boost to Chemoradiotherapy (Dose Level 2)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage II or stage III non-small cell lung cancer, or stage IV non-small cell lung cancer that will be treated with curative intent * Evaluated by a surgeon and deemed inoperable * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with chest CT scan. * No active malignancy within the past 5 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix * 18 years or older * Life expectancy of greater then 6 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Normal organ and marrow function as outlined in the protocol * Forced expiratory volume (FEV1) of 1 L or greater OR 50% or greater of predicted Exclusion Criteria: * Primary tumor size greater then 6cm * Prior history of thoracic radiotherapy * May not be receiving any other study agents * History of pulmonary fibrosis * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide * Primary tumor \< 1.5 cm beyond hilar lymphadenopathy (if any) and 1.5 cm from proximal bronchial tree, defined as the trachea, right and left mainstem bronchus, and lobar bronchi until the 1st lobar segment * Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breast feeding women * Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin * Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy * Patients who are planned to receive the following medication: granulocyte colony-stimulating factor (G-CSF), bevacizumab, cetuximab, cyclosporine, anti-tumor necrosis factor agents, amifostine.
References
Publications (0)
Data not yet available
No reference posted for this study.