Squamous Cell Lung Cancer
Conditions
Keywords
Squamous cell lung cancer, Pemetrexed, Radiosensitivity
Brief summary
To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.
Interventions
DRUGpemetrexed
Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
DRUGcisplatin
Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
RADIATIONthoracic radiation therapy
Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
DRUGdocetaxel
Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer; * All sites of disease must be amenable to definitive radiotherapy; * Age 18 years to 75 years; * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; * Forced expiratory volume in 1 second(FEV1)\> 0.75L; * No previous chest radiotherapy, immunotherapy or biotherapy; * Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter; * Patients and their family signed the informed consents;
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 years | — |
| Local control rate | 3 years | — |
| The short-term quality of life (QOL) assessed using FACT-E score | 4 months | FACT-E score at the 4 months after docetaxel consolidation therapy |
| Rate of CTCAE grade 2 or higher radiation pneumonitis | 1 years | The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy |
Countries
China
Contacts
Primary ContactShenglin Ma, MD
Outcome results
None listed