High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Radiation: high dose chemoradiotherapy
- Registration Number
- NCT03598517
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description high dose chemoradiotherapy high dose chemoradiotherapy all eligible patients receive image-guided intensity-modulated radiotherapy 60 Gy in 30 fractions over 6 weeks and concurrent weekly paclitaxel and cisplatin，followed by hyperfractionated intensity-modulated radiotherapy boost to residual metabolic disease concurrent with the same chemotherapy regimen, followed by adjuvant chemotherapy 6 weeks after completion of radiation therapy.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method toxicities 2 year Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.
Trial Locations
- Locations (1)
Shanghai Genernal Hospital
🇨🇳Shanghai, Shanghai, China