Clinical trial · Interventional
Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer
NCT00059761CI-TRIAL-00019792completedPhase 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: Drugs used in chemotherapy 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 I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Sequence A: Level 1
- description
- Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
- interventionNames
- Drug: cisplatin
- Drug: irinotecan hydrochloride
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Sequence B: Level 1
- description
- Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
- interventionNames
- Drug: cisplatin
- Drug: irinotecan hydrochloride
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer by one of two methods:
* Fine needle aspiration biopsy
* Two positive sputa
* Must have limited disease as defined by all of the following:
* Stage I-IIIB
* Confined to 1 hemithorax
* No T4 tumor based on malignant pleural or pericardial effusion
* Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed
* No N3 disease based on contralateral hilar or contralateral supraclavicular involvement
* Measurable or evaluable disease
* Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise
* No complete tumor resection
* No pericardial effusion (regardless of cytology)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 120,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* No known Gilbert's disease
Renal
* Creatinine no greater than 1.5 mg/dL
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic heart disease
Pulmonary
* Forced expiratory volume (FEV)\_1 at least 1.0 L/sec
* No uncontrolled bronchospasms
* No uncompensated chronic obstructive pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing peripheral neuropathy grade 2 or greater
* No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix
* No other concurrent serious medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
* No concurrent intensity-modulated radiotherapy
Surgery
* See Disease Characteristics
Other
* At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks
* Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period
* At least 14 days since prior Hypericum perforatum (St. John's wort)
* No concurrent EIACDs
* No concurrent amifostine during chemoradiotherapy
* Concurrent gabapentin or other non-EIACDs allowedReferences
Publications (2)
- RESULTLanger CJ, Swann S, Werner-Wasik M, et al.: Phase I study of irinotecan (Ir) and cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SCLC): early analysis of RTOG 0241. [Abstract] J Clin Oncol 24 (Suppl 18): A-7058, 378s, 2006.
- RESULTLanger C, Swann S, Werner-Wasik M, et al.: Phase I study of combination irinotecan and cisplatin and either twice daily thoracic radiation (45Gy) or once daily thoracic radiotherapy (70Gy) in patients with limited small cell lung carcinoma (SCLC): early toxicity analysis of RTOG 0241. [Abstract] Lung Cancer 49 (Suppl 2): A-P-777, S323, 2005.