High Dose Radiation Therapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Intensity-modulated Hyperfractionated Radiotherapy Boost to Residual Metabolic Disease Following Standard Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598517
• Other study ID #: SGH201816
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2020
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Ningning Cheng, MD
• Phone: 37798364
• Email: ningcnn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• high 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.

Locations

Country	Name	City	State
China	Shanghai Genernal Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival rate	survival time was measured from the date of study enrollment to the date of death or last follow-up	2 year
Secondary	toxicities	Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.	2 year