Clinical Trial: HS-PCI in Locally Advanced Adenocarcinoma of the Lung

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase III Trial of Hippocampal-sparing Prophylactic Cranial Irradiation (HS-PCI) in Locally Advanced (Stage IIIA/IIIB) Adenocarcinoma of the Lung

Brief Summary: The primary aim of this study is evaluate the impact of hippocampal-sparing prophylactic cranial irradiation (HS-PCI) on survival status in patients with nodal-positive (locally advanced) adenocarcinoma by comparing overall survival rates of patients undergoing HS-PCI to that of patients without this intervention. In addition, this study aims to investigate whether HS-PCI is detrimental on neurocognitive function and to evaluate its impact on the patient's quality of life.

Detailed Summary:

Patients with locally advanced non-small cell lung cancer (LA-NSCLC) have an increased risk of developing central nervous system (CNS) metastases during the course of their disease. The brain is the most common site of failure after first-line therapies (independent of combined sequential or consolidation chemotherapy). Recent studies employing multimodal therapy have reported overall brain metastasis rates ranging from 22% to 55%, and the rates for brain as first site of relapse range from 16% to 43%.

Prophylactic cranial irradiation (PCI) results in a 2-3 fold lower incidence of brain metastasis. However, randomized studies have failed to demonstrate improved overall survival (OS) after PCI.

One of the major weaknesses of these trials is the unselected mixed pool of stage III patients (stage III A and B, lymph node status N0 to N2, squamous and non-squamous histology etc.). A broad variety of studies have shown that a certain subset of patients with NSCLC (e.g. cancers with adenocarcinoma histology, multilevel nodal involvement) are at highest risk for brain metastases. Furthermore, the risk for brain metastases appears to be specifically higher in younger patients (age <60 years), although this collective commonly undergoes more frequently chemotherapy and/or more aggressive regimens than elderly patients.

Prevention of CNS metastases, even for LA-NSCLC patients with other sites of failure, will improve quality of life and, for patients controlled extracranially, will improve survival. Meta analyses performed on data from several Radiation Treatment Oncology Group (RTOG) studies have shown that longer survival for patients with LA-NSCLC treated with either radiation alone or radiochemotherapy is associated with an increased incidence of CNS metastases. Although the ad
Sponsor: Universitätsmedizin Mannheim

Current Primary Outcome: 1-year overall survival rate [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival (OS) [ Time Frame: 1 year ]
  • Progression-free survival (PFS) [ Time Frame: 1 year ]
  • Incidence of brain metastasis [ Time Frame: 1 year ]
  • Incidence of brain metastases within the hippocampal avoidance volume [ Time Frame: 1 year ]
  • Adverse events [ Time Frame: 1 year ]
  • Neurocognitive function (NCF), measured by Verbal Learning Memory Test (VLMT) [ Time Frame: 1 year ]

    Verbal Learning Memory Test (VLMT)

    Barthel Activities of Daily Living (ADL) Index

  • Quality of Life (QoL), measured by Quality of Life Questionnaires / core and brain module (EORTC-QLQ-C30/BN20) [ Time Frame: 1 year ]
    Quality of Life Questionnaires / core and brain module (EORTC-QLQ-C30/BN20)
  • Activities of Daily Living (ADL), measured by Barthel Index [ Time Frame: 1 year ]
    Barthel Index


Original Secondary Outcome: Same as current

Information By: Universitätsmedizin Mannheim

Dates:
Date Received: January 7, 2015
Date Started: January 2016
Date Completion: March 2019
Last Updated: December 2, 2015
Last Verified: December 2015