Trials / Unknown
UnknownNCT03588494
Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer
Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 318 (estimated)
- Sponsor
- Affiliated Hospital of North Sichuan Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | concurrent chemoradiotherapy (CCRT) | Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed. |
| DRUG | Endostar for one cycle | Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1). |
| DRUG | Endostar for two cycles | Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28). |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-09-01
- Completion
- 2021-09-01
- First posted
- 2018-07-17
- Last updated
- 2018-07-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03588494. Inclusion in this directory is not an endorsement.