Clinical trial · Interventional
Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study
- 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 cisplatin, irinotecan, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction and consolidation chemotherapy
- description
- Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43
- interventionNames
- Drug: carboplatin
- Drug: cisplatin
- Drug: etoposide
- Drug: irinotecan hydrochloride
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Efficacy, in terms of survival, at 2 years after initiation of study treatment
Secondary outcomes (6)
- measure
- Overall response rate as measured by RECIST at completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Histologically or cytologically documented small cell lung cancer of limited stage. 1.1 Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes. 1.2 Although they are usually defined as having limited stage small cell lung cancer, because of concern about the volume of the radiation field that would be required, patients with clinically suspected or confirmed supraclavicular lymph node metastases, patients with pathologically enlarged contralateral hilar lymph nodes, and patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are NOT eligible. 2. All Patients must have Measurable Disease 2.1 Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. 2.2 Pleural/pericardial effusions are not considered measurable. 3. Age ≥18 4. ECOG Performance status 0-2. 5. Prior Treatment - No prior chemotherapy or radiotherapy for SCLC. 6. No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. 7. Non-pregnant and non-nursing because of significant risk to the fetus/infant. 8. Required Initial Laboratory Values * Granulocytes ≥1,500/µl * Platelets ≥100,000/µl * Serum Creatinine ≤ULN * Bilirubin \<1.5 mg/dl * SGOT (AST) \<2 x ULN
References
Publications (1)
- RESULTKelley MJ, Bogart JA, Hodgson LD, Ansari RH, Atkins JN, Pang H, Green MR, Vokes EE. Phase II study of induction cisplatin and irinotecan followed by concurrent carboplatin, etoposide, and thoracic radiotherapy for limited-stage small-cell lung cancer, CALGB 30206. J Thorac Oncol. 2013 Jan;8(1):102-8. doi: 10.1097/JTO.0b013e31827628e1. PMID 23196276