NCT02400424

Study of the Efficacy of SBRT on Unresectable Peripheral Primary Tumor

Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor. Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor. The number of patients required in this multicenter prospective study is 70. This is a prospective, multicenter, non comparative and non randomized study.

Detailed description

Stereotactic radiotherapy or SBRT (Body Stereotactic Radiation Therapy) allows to irradiate with high dose limited lesions size with a local control surrounding of 80-98% and with a low level of toxicity. We propose to realize a classic concomitant RT-CT for mediastinal irradiation and combine this treatment with stereotactic RT for peripheral primary tumor. The estimated inclusion period is approximately 3 years. Follow-up duration for each patient is 2 years. The duration of the research is 5 years.

Conditions

• Non-small-cell Lung Carcinoma

Interventions

Type	Name	Description
RADIATION	SBRT	54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-02-13
• Completion: 2020-06-25
• First posted: 2015-03-27
• Last updated: 2021-02-09

Locations

2 sites across 1 country: France