Non-small Cell Lung Cancer Stage Ⅱ, Non-small Cell Lung Cancer Stage ⅢA
Conditions
Keywords
Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection
Brief summary
The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.
Detailed description
Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases. For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival. S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against NSCLC.
Interventions
DRUGS1 capsule
Within four weeks after the completely resection, S-1 was administered orally twice a day, after meals on days 1 to 14. The actual dose of S-1 was selected as follows: in a patient with body surface area (BSA)\<1.25 m2 40mg twice a day, 1.25 m2≤BSA\<1.5 m2 50mg twice a day, and 1.5 m2≤BSA 60mg twice a day. Cisplatin (75 mg/m2) was administered intravenously on day 1 The treatment regimen was repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.
DRUGVinorelbine
Vinorelbine (25 mg/m2) is administered intravenously on day 1, and day 8. Cisplatin (75 mg/m2) is administered intravenously on day 1. The treatment regimen is repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC) * Must be able to receive the therapy of the study within four weeks after the completely resection
Exclusion criteria
* Systemic anticancer treatment * local radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival rate | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 4 years | The period from the date of enrollment to the date on which the recurrence was first confirmed. For patients who died before disease progression from any cause, death was attributed to recurrence. |
| Overall survival | 4 years | The period from the date of enrollment to the date of death from any cause. |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. | The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 4.0. |
| Quality of life (QOL) | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. | QOL was assessed with the lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale(LCSS). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Molecular marker measurement for NSCLC | Some molecular markers in the serum will be tested at 6-month intervals after surgery until recurrence | The measured molecular markers include carcinoembryonic antigen (CEA), tissue polypeptide specific antigen (TPS), neuron-specific enolase (NSE), carbohydrate antigen 199 (CA199), cytokeratin fragment 19 ( CYFRA 21-1), and squamous cell carcinoma antigen (SCC Ag) |
Countries
China
Contacts
Primary ContactJun Feng Liu, Professor
Backup ContactYun Jiang Liu, Professor
Outcome results
None listed