Clinical Trial: Role of SPECT in Radiotherapy of Lung Cancer and Toxicity Evaluation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of SPECT in Radiotherapy Treatment Planning and Toxicity Evaluation for the Patients With Stage I-III NSCLC: a Randomized Phase II Trial

Brief Summary: Overall objective of the study is to compare the use of SPECT in radiotherapy treatment planning with standard CT-based radiotherapy for stage I-III non-small-cell lung cancer patients

Detailed Summary:

Primary objective:

-To compare the rate of grade 2 or higher pneumonitis amongst patients with stage III NSCLC treated with radiotherapy using SPECT in radiotherapy treatment planning versus standard CT-based radiotherapy planning;

Secondary Objectives:

  • To evaluate SPECT as a tool to predict lung toxicity;
  • To establish estimates for the incidence and severity of pulmonary tissue effects observed in stage III NSCLC patients treated with radiotherapy;
  • To generate hypotheses for subsequent use of SPECT-CT-based treatment planning as a method for minimization of toxicity risks
  • To generate hypotheses for modeling studies of SPECT-CT-based treatment planning for dose-escalation;
  • To compare the loco-regional control, time to progression and overall survival of patients treated with SPECT-based plan versus standard CT-based plan
  • To compare the quality of life in patients randomized to the two study arms.

This trial is a single center, randomized phase II study. All patients will irrespective of their registration in the trial receive radiotherapy according to the standard treatment regimen at the Department of Oncology, Aarhus University Hospital. Participation implies baseline and follow-up procedures. In the treatment planning phase patients will be randomized to one of the following arms: Arm 1 SPECT/CT-based treatment plan with functional dose-volume parameters and Arrm 2 Standard CT-based plan with conventional dose-volume parameters.

The trial will consist of two part
Sponsor: University of Aarhus

Current Primary Outcome: Grade 2 radiation pneumonitis [ Time Frame: measured 0-12 months after completed radiotherapy ]

The primary endpoint is grade 2 pneumonitis, defined according to the NCI Common Toxicity Criteria for Adverse Events (CTC) version 4.0.

Estimation of the occurrence of pulmonary tissue effects:

Number of patients developing pulmonary toxicity over grade 2 in both treatment arms according to the Common Terminology Criteria for Adverse Events CTC v. 4.0 and measured serially from 0 to 12 months after radiotherapy, as well as according to the SOMA-LENT scale measured serially from 0 to 12 months after radiotherapy



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • quality of life [ Time Frame: 0-12 months after radiotherapy ]
    Change in quality of life according to the standard quality of life questionnaires
  • Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more) [ Time Frame: 12 months after radiotherapy ]
    Estimation of conventional (from CT alone) and functional (from SPECT)dose-volume parameters (MLD and V5-50) and their correlation with pulmonary toxicity will be done.
  • Progression-free survival [ Time Frame: at 12 months after radiotherapy ]
    Proportion of patients alive with no evidence of disease as per the RECIST criteria in the SPECT arm compared to CT arm


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: December 6, 2012
Date Started: June 2012
Date Completion:
Last Updated: July 6, 2015
Last Verified: July 2015