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

NCT02720614 | Completed Phase 2

• 1 other identifier: NorthChinaPBGH
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

accelerated hypofractionated radiotherapy; three-dimensional conformal radiation therapy; concurrent radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Severe and Life-threatening Adverse Events (AE)

  intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0))

  Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)

Secondary Outcomes (1)

• Percentage of Participants with Progression Free Survival (PFS) at 1 Year

  Baseline and 1 year

Study Arms (1)

Hypofractionated radiation/chemotherapy

EXPERIMENTAL

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.

Radiation: Hypofractionated radiation/chemotherapy

Interventions

Hypofractionated radiation/chemotherapy RADIATION

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

Hypofractionated radiation/chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LIN QIANG: lead

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  PMID: 27108080 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Qiang Lin, Dr

  North China Petroleum Bureau General Hospital of Hebei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 28, 2016
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 28, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share