Clinical trial · Interventional
Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
NCT01055197CI-TRIAL-00036098completedPhase 2Results postedClinicalTrials.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 uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer. PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic Cranial Irradiation | Radiation | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PCI
- description
- Prophylactic Cranial Irradiation (PCI)
- interventionNames
- Radiation: Prophylactic Cranial Irradiation
- type
- EXPERIMENTAL
- label
- PCI + Consolidation RT
- description
- Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
- interventionNames
- Radiation: Prophylactic Cranial Irradiation
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Overall Survival (12-month Rate Reported)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months\* * Has 1-4 extracranial metastatic lesions NOTE: \*Diagnosis made before treatment with chemotherapy * Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria: * Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if radiotherapy has been delivered to primary disease with chemotherapy, there must be complete or partial response in ≥ 1 of the sites that has not been treated with radiotherapy) * No progression in any site * No limited stage SCLC, even if disease progressed * No brain or central nervous system (CNS) metastases PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 * Platelets ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed) * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver) * Serum bilirubin \< 1.5 times ULN (for patients who will receive radiotherapy to the liver) * Serum creatinine \< 1.5 times ULN (for patients who will receive radiotherapy to the kidneys) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No severe, active co-morbidity, defined as any of the following: * Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study registration PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 \[except for neuropathy and alopecia\]) * Thoracic radiotherapy administered concurrently with or before chemotherapy for the current diagnosis allowed (these patients will not receive mediastinal radiotherapy per protocol) * No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields * No concurrent chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.