Role of SPECT in Radiotherapy of Lung Cancer and Toxicity Evaluation

NCT01745484 | Completed DMC

• 1 other identifier: KFE-1203
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small-cell Lung Cancer; Radiation Pneumonitis

Keywords

SPECT; Toxicity; Non-small-cell lung cancer; Definitive Radiotherapy; Radiation pneumonitis; Randomized study

Outcome Measures

Primary Outcomes (1)

• Grade 2 radiation pneumonitis

  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

  measured 0-12 months after completed radiotherapy

Secondary Outcomes (3)

• Overall quality of life score

  0-12 months after radiotherapy

• Mean lung dose (MLD) and V5-50(volume of the lung receiving 5-50 Gy or more)

  12 months after radiotherapy

• Progression-free survival

  at 12 months after radiotherapy

Study Arms (1)

Arm 1

EXPERIMENTAL

SPECT scan will be performed at baseline. Patients will receive radiotherapy according to standard CT-based plan with conventional dose-volume histogram

Other: SPECT-based treatment plan

Interventions

SPECT-based treatment plan OTHER

SPECT will be performed on all patients at baseline. Two treatment plans will be made- functional SPECT-based plan and conventional CT-based plan. Randomization will take place if both plans are satisfying established criteria for tumour coverage and normal tissue sparing. Randomization between Arm 1 and Arm 2 will be done, where the patients will be treated either by SPECT-plan or by CT-plan respectively. The SPECT data are viewed as a multicoloured image in the spectrum colour setting to allow accurate volume contouring around a predefined colour. The threshold level is adjusted individually for each patient in order to match the size of the SPECT image within the lung volumes defined on CT. A new contour of functional lung is created from the SPECT images using a threshold of 30% of the maximum uptake for each patient. A treatment plan is generated. The principal objective for each plan is to minimize the volume of lungirradiated

Also known as: Single Photon Emission Computed Tomography

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage I-III non-small cell lung cancer, histologically verified
• Referred for definitive radiotherapy to the Department of Oncology, Aarhus University Hospital
• Meet the criteria for curatively intended radiotherapy described in details in the national guidelines
• Concurrent chemotherapy is accepted
• Adults over 18, that have given oral and written informed consent before patient registration
• The patients can only be randomized in this trial once

You may not qualify if:

• other uncontrolled malignancies
• human albumin allergy
• any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Pneumonitis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Officials

• Katherina Farr, MD

  Department of Oncology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

DK (1)