Clinical trial · Interventional
Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to Poor Accrual
Summary
Brief summary (as posted)
The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Chemoradiotherapy | Radiation | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- DG -\> RT
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine
- Radiation: Chemoradiotherapy
- type
- EXPERIMENTAL
- label
- 2
- description
- DG -\> RT -\> DCarbo
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine
- Drug: Carboplatin
- Radiation: Chemoradiotherapy
Primary outcomes (1)
- measure
- Time to tumor progression (TTP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC * no previous therapy for NSCLC is allowed * age \>18 years * bidimensionally measurable disease * performance status (WHO) 0-2 * absence of pleural effusion * adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function * life expectancy of more than 3 months * written informed consent Exclusion Criteria: * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * malnutrition (loss of ≥ 20% of the original body weight) * performance status: 3-4 * sensor or motor neuropathy \> grade I * second primary malignancy, except for non-melanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women
References
Publications (0)
Data not yet available