Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

NCT ID: NCT02720614

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.

Detailed Description

Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.

Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.

Conditions

Non-small Cell Lung Cancer

Study Design

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

Study Groups

Hypofractionated radiation/chemotherapy

Hypofractionated radiation：Patients receive accelerated hypofractionated radiation: three-dimensional conformal radiation therapy (3-DCRT) with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks.

Chemotherapy: Regimen 1 is as follows: vinorelbine (NVB) was administered by intravenous infusion at a dose of 25 mg/m2 on day 1 (d1) and day 8 (d8), and carboplatin (CBP) is administered at a concentration-time curve (AUC) of 5 mg/ml on d8. This treatment was repeated every 28 days. One cycle of chemotherapy is performed concurrently with the radiotherapy.

Chemotherapy: Regimen 2 is as follows: paclitaxel at 30 mg/m2 and cisplatin at 20 mg/m2 (TP) are administrated every week for 5 weeks continuously.

Group Type: EXPERIMENTAL

Hypofractionated radiation/chemotherapy

Intervention Type: RADIATION

Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin

Interventions

Hypofractionated radiation/chemotherapy

Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
• The Karnofsky performance status (KPS) score ≥70.
• The expected survival time ≥3 months.
• Adequate blood, liver, lungs and kidney function
• Accessible contact information
• Informed consent required before enrollment.

Exclusion Criteria

• Pregnant or breastfeeding.
• Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years)
• Cannot receive concurrent chemotherapy due to medical reasons.
• Superior vena cava syndrome.
• Severe lung diseases that affected lung function.

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

Sponsors

LIN QIANG

OTHER

Sponsor Role: lead

Responsible Party

LIN QIANG

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qiang Lin, Dr

Role: STUDY_CHAIR

North China Petroleum Bureau General Hospital of Hebei Medical University

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Other Identifiers

NorthChinaPBGH

Identifier Type: -

Identifier Source: org_study_id