Clinical trial · Interventional
Cisplatin, Vinorelbine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
A Randomized Phase III Trial of Sequential Chemotherapy Followed By Radical Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Chemotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer and Good Performance Status
- 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 and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control arm (SEQ): | Drug | — | UNRESOLVED |
| Experimental arm (CON): | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sequential arm (SEQ)
- description
- Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
- interventionNames
- Drug: Control arm (SEQ):
- type
- EXPERIMENTAL
- label
- Experimental arm (CON)
- description
- Concurrent chemo-radiotherapy \[55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20\] followed by two cycles of cisplatinum/vinorelbine.
- interventionNames
- Drug: Experimental arm (CON):
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) * Patients with stage IIIB disease must not have a pleural effusion that is cytologically proven to be malignant * Inoperable disease * Disease must be able to be encompassed within a radical radiotherapy treatment volume PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * Life expectancy \> 3 months * Patient considered able to tolerate platinum-based chemotherapy and radical radiotherapy * Glomerular filtration rate ≥ 60 mL/min * WBC \> 3,000/mm³ * Absolute neutrophil count \> 1,500/mm³ * Hemoglobin \> 10.0 g/dL * Patients with hemoglobin between 10 and 12 g/dL at randomization require a blood transfusion to ensure hemoglobin \> 12 g/dL before starting radiotherapy * Platelet count \> 100,000/mm³ * FEV\_1 ≥ 1.0 L or DLCO (transfer factor) ≥ 50% of predicted * Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \< 1.5 times ULN * Transaminases ≤ 1.5 times ULN * Bilirubin ≤ 1.5 times ULN * No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease) * Not pregnant or nursing * Fertile patients must agree to use effective contraception * Negative pregnancy test * No other previous or current malignant disease likely to interfere with protocol treatment or comparisons PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or investigational agents
References
Publications (0)
Data not yet available