Clinical trial · Interventional
Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC
A Phase II Study of Definitive Concurrent Radiation Therapy With Cisplatin and Irinotecan Chemotherapy in Locally Advanced In-operable 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
Why stopped (as posted): PI decided to terminate study
Summary
Brief summary (as posted)
This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" non-small cell lung cancer (NSCLC).
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 Neoplasms, Non-Small Cell Lung Cancer | Lung Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All enrolled patients
- description
- Induction Chemotherapy Cycle 1 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 1 and 8 Concurrent Chemotherapy Cycles 2-4 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 22 and 29, days 43 and 50, and days 64 and 71 along with radiation therapy of 60-70 Gy in 2 GY fractions on days 22 -71.
- interventionNames
- Drug: Irinotecan
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan
- timeFrame
- Three years after the last patient has completed treatement
- measure
- Estimate the progression-free survival
- timeFrame
- Three years after the last patient has completed treatement.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma adenosquamous and sarcomatoid carcinomas. * Patients with Pancoast tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. Pancoast tumor patients will be so-noted in the registry. * Patients must be ≥ 18 years of age. * Patients with Zubrod (ECOG) performance status ≤ 2. * Adequate hematologic function defined as: ANC ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl. * Patients with weight loss ≤ 20% over the past 3 months. * Patients with a pleural effusion that is proven cytologically negative or is too small to tap. * Women of childbearing potential must agree to practice effective contraception throughout the study and for four weeks after completion of treatment. * Pretreatment evaluations required for eligibility include: * A medical history, physical examination, and assessment of Zubrod performance status within 4 weeks prior to study entry. * CBC with differential and platelet count, and laboratory profile must be completed within 4 weeks prior to study entry. * CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry. * For women of childbearing potential, a serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) must be performed within a week prior to the start of protocol treatment. * Medical Oncology and Radiation Oncology consultation and approval. * Patients must sign a study-specific consent form prior to study entry. Exclusion Criteria: * Small cell carcinomas or carcinoid histology. * History of any malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers. * Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician. * Cytologically malignant effusions. * Radiographic evidence of metastatic disease. * Active pulmonary infection not responsive to antimicrobial therapy. * History of significant or symptomatic interstitial pneumonitis. * Significant symptomatic cardiac disease, for example, unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias. * Patients with \> grade 2 neuropathy. * Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration. * Women of childbearing potential who are unwilling to practice effective contraception throughout the study and for four weeks after completion of treatment. * Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.
References
Publications (0)
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