Clinical trial · Interventional
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)
- 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. Combining more than one drug may kill more tumor cells. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects. PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of hospitalization due to toxicity
Secondary outcomes (6)
- measure
- Need for hospitalization for chemotherapy administration
- measure
- Tumor response rate
- measure
- Overall survival
- measure
- Relief of tumor-related symptoms
- measure
- Effect on Karnofsky performance status
- measure
- Toxicity as measured by NCIC CTC v2.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed inoperable non-small cell lung cancer * Stage IIIA, IIIB, or IV * Not eligible for curative radiotherapy or surgery * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 50-100% Life expectancy * At least 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 2.5 times ULN * Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal * Creatinine no greater than ULN OR * Creatinine clearance at least 60 mL/min Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study completion * No active infection * No serious systemic disorder that would preclude study participation * No grade 2 or greater peripheral neuropathy * No significant neurological problems (e.g., seizures or psychiatric disorders) * No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic chemotherapy * No other concurrent chemotherapy during or for 7 days after study therapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy * No concurrent radiotherapy during or for 7 days after study therapy Surgery * See Disease Characteristics Other * At least 12 weeks since prior investigational agents * No other concurrent antitumor therapy * No concurrent experimental medications
References
Publications (0)
Data not yet available