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

NCT ID: NCT03598517

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2022-07-01

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

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

high dose chemoradiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chen tingfeng

director, department of radiation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingfeng Chen, MD

Role: STUDY_DIRECTOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Genernal Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ningning Cheng, MD

Role: CONTACT

ningcnn@163.com

37798364 ext. 8119

Yong Liu, MD

Role: CONTACT

drliuyrt@163.com

37798364

Facility Contacts

Ningning Cheng

Role: primary

ningcnn@163.com

37798364 ext. 8119

yong Liu

Role: backup

drliuyrt@163.com

37798364 ext. 8110

Other Identifiers

SGH201816

Identifier Type: -

Identifier Source: org_study_id