Clinical trial · Interventional
Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients
Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
NCT02039518CI-TRIAL-00013501unknownPhase 2ClinicalTrials.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)
The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| observation group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gemcitabine
- description
- gemcitabine 1000mg/m2，d1，d8，Q3W
- interventionNames
- Drug: gemcitabine
- type
- OTHER
- label
- observation group
- description
- observation
- interventionNames
- Other: observation group
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- from the first cycle of treatment (day one) to two month after the last cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years 2. PS=0,1,2 3. Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer 4. Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD 5. Expected lifetime\>12 weeks 6. Signed written informed consent Exclusion Criteria: Small cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of \>CTCAE caused tumor treatment past grade 2 toxicity Ccr\<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency： 1. Tbil\> 1.5×ULN 2. ALT and AST \> 2.5×ULN (Patients with liver metastasis\>5×ULN) Alkaline phosphatase\>2.5 ×ULN(Patients with liver metastasis\>5×ULN) 3. Severe symptomatic heart disease 4. Symptomatic brain metastases 5. In the last 5 years have been or are suffering from other histological types of malignant tumor 6. There are serious or uncontrolled systemic diseases 7. During the study period planned radiotherapy on target lesion 8. During the study period, plans to use other antineoplastic therapy 9. Clinical study on treatment of 30 days beginning period prior to participate in any study drug
References
Publications (0)
Data not yet available
No reference posted for this study.