Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC) (DO201001)

Third Military Medical University

Status: Unknown

Conditions: Non-small Cell Lung Cancer

Treatments: Radiation: 3DCRT; Drug: Gemcitabine, Nedaplatin, iV; Drug: Gemcitabine，Nedaplatin, BAI

Study type: Interventional

Funder types: Other

Identifiers

NCT01201044

DO210101

DO201001

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage IIIA&IIIB NSCLC
• male or female, Age ≥18Years, ≤70Years
• Life expectation of at least 12weeks.
• PS performance 0-2
• Measurable disease according to the Response Evaluation Criteria in Solid Tumours ( RECIST)

Exclusion criteria

• Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Gemcitabine, Nedaplatin,BAI plus 3DCRT

Experimental group

Description:

Gemcitabine(1000mg/m2)，Nedaplatin(60mg/m2),BAI, Day 1/4weeks. 4weeks per cycle. Tumor assessment will be perforemd after 2 cycles. if no PD, patient will be treated with 3DCRTfor 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year..

Treatment:

Radiation: 3DCRT

Drug: Gemcitabine，Nedaplatin, BAI

Radiation: 3DCRT

Gemcitabine, Nedaplatin, IV Plus 3DCRT

Other group

Description:

Gemcitabine 100mg/m2, D1 \& D8 every 4 weeks Nedaplatin 75mg/m2, D1 every 4 weeks. every 4 weeks per cycle. Tumor assessment will be performed after 2 cycles. if no PD, patient will be treated with 3DCRT for 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year.

Treatment:

Radiation: 3DCRT

Drug: Gemcitabine, Nedaplatin, iV

Radiation: 3DCRT