Non-small Cell Lung Cancer
Conditions
Brief summary
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.
Detailed description
Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival
Interventions
RADIATIONhigh dose chemoradiotherapy
Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
* Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer. * Age 1 8-75. * Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2. * Stage III ( American Joint Committee on Cancer AJCC, 7th ed.). * No prior radiation to the thorax that would overlap with the current treatment field. * Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/ mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</ =1 .5 times ULN. * A signed informed consent must be obtained prior to therapy. * Induction chemotherapy is allowed. * Life expectancy more than 3 months
Exclusion criteria
* Patients with any component of small cell lung carcinoma are excluded from this study. * Patients with evidence of a malignant pleural or pericardial effusion are excluded. * Prior radiotherapy that would overlap the radiation fields. * Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. * Known hypersensitivity to paclitaxel. * Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. * Conditions precluding medical follow-up and protocol compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival rate | 2 year | survival time was measured from the date of study enrollment to the date of death or last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| toxicities | 2 year | Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4. |
Countries
China
Contacts
Primary ContactNingning Cheng, MD
Backup ContactYong Liu, MD
Outcome results
None listed