Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer
- 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: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Rate of local/regional control
- measure
- Rate of systemic disease control
- measure
- Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy
Secondary outcomes (3)
- measure
- Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIA (N2) or IIIB disease
* Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
* No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
* Unresectable disease
* No known brain metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm³
* Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
* Platelet count ≥ 100,000/mm³
* Creatinine \< 1.5 mg/dL
* Total bilirubin \< 2 times upper limit of normal (ULN)
* Transaminases \< 3 times ULN
* Patient compliance and geographic proximity that allow adequate follow up
* No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
* No history of significant neurological or mental disorder, including seizures or dementia
* No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
* No active cardiac disease not controlled by therapy
* No myocardial infarction within the past 12 months
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy for NSCLC
* No other concurrent systemic chemotherapy, investigational drug, or radiotherapyReferences
Publications (0)
Data not yet available