Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:51 AM
Ignite Modification Date: 2025-12-25 @ 2:51 AM
NCT ID: NCT05331833
Brief Summary: About 20-30% of patients with stage III non-small cell lung cancer (NSCLC) are unresectable and definitive concurrent radiochemotherapy is the standard care. Intensity-modulated radiation therapy (IMRT) is a new radiotherapy technology, including gross tumor volume (GTV), clinical target volume (CTV), internal target volume (ITV), and planning target volume (PTV) as delineated target volumes. The treatment failure of local advanced NSCLC is mainly caused by local recurrence accounted for 50% and distant metastasis accounted for 50%. Local recurrence occurs both within the radiation field and outside the radiation field. Elective nodal irradiation (ENI) was designed before, however the adverse events (AEs) was not satisfactory. Afterwards, involved field radiotherapy (IFRT) showed that a reduced irradiation field did not increase local recurrence, and lowered the AEs Thus, IFRT has been broadly used in clinical work instead of ENI. IFRT still has disadvantages, including the risk of radiation respiratory events and radiation esophagitis, can the irradiation area be further reduced to reduce adverse reactions without affecting the efficacy? Positron emission tomography -computed tomography (PET-CT) can accurately assess primary tumor and metastatic lymph nodes in NSCLC patients better than CT . A meta-analysis of 39 clinical studies showed that the median sensitivity and specificity of PET-CT for the detection of lymph node involvement were 85% and 90%, respectively, while those of CT alone were only 61% and 79%, respectively. The radiotherapy application of PET-CT in image acquisition can ensure the delineation of both primary tumor and mediastinal lymph node metastasis. Under this condition, can the radiation field be further reduced to lower the dose to normal tissue and radiotherapy-associated AEs? A dosimetry study showed that when a dose of 60 Gy was given to the primary tumor and positive mediastinal lymph nodes, even if the CTV was omitted, a dose of 50 Gy was sufficient to cover the subclinical area.
Detailed Description: A dosimetry study showed that when a dose of 60 Gy was given to the primary tumor and positive mediastinal lymph nodes, even if the CTV was omitted, a dose of 50 Gy was sufficient to cover the subclinical area.
Study: NCT05331833
Study Brief:
Protocol Section: NCT05331833