Optimizing (Breathing) Techniques for Radiotherapy of Esophageal and Lung Carcinomas

NCT02497664 | Completed

• 1 other identifier: RT2015-04
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Neo-adjuvant chemoradiotherapy (neo-CRT) is increasingly applied in the curative treatment of esophageal cancer, with the aim to downstage the tumor, to increase the rate of radical resections, and consequently to improve the survival rates. Due to improved survival, it will become increasingly important to minimize the radiation-induced toxicity among long-term survivors. In the management of locally advanced non small cell lung cancer (NSCLC), radiotherapy is the standard treatment modality. However, the dose that can be safely applied to the tumour is limited by the risk of cardiac and pulmonary complications, which even led to decreased survival in a randomised study, when a higher tumor dose was administered \[1\]. Radiation induced pulmonary and cardiac toxicity are the most important late side effects after thoracic radiotherapy \[2-4\]. The aim of this study is to reduce the radiation dose of heart (and lungs) in order to reduce the toxicity risk. In recent years, the active breathing control (ABC) technique has been introduced in the radiotherapy for left sided breast cancer patients, to minimize the radiation dose to the heart. These patients are irradiated in the inspiration phase, in which the distance between the heart and the breast is largest, while the lungs extend. Breath hold might also be beneficial for radiotherapy of esophageal and lung tumors. For these patients the expiratory phase might theoretically be more beneficial to reduce the heart dose. However, the inspiration phase might be better for the dose to the lungs, which consequently allows cardiac dose reduction.

Conditions

Esophageal Cancer; Lung Cancer

Keywords

Radiotherapy; Active Breathing Control Technique

Outcome Measures

Primary Outcomes (1)

• Mean Hart Dose (MHD)

  At 6 weeks after start of radiation therapy

Secondary Outcomes (4)

• Mean Lung Dosis (MLD)

  At 6 weeks after start of radiation therapy

• Position of the heart in relation to the target volumes

  At 6 weeks after start of radiation therapy

• Internal Target Volume (ITV) margin (margin for breathing movement defined as ITV - Gross Tumor Volume (GTV))

  At 6 weeks after start of radiation therapy

• Dose Volume Histogram (DVH) parameters of the heart

  At 6 weeks after start of radiation therapy

Study Arms (1)

Active Breathing Control

OTHER

Planning-CT will be made of patients using the Active Breathing Control Technique (in expiration and inspiration phase)

Other: Active Breathing Control

Interventions

Active Breathing Control OTHER

Active Breathing Control

Eligibility Criteria

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

You may qualify if:

• Histologically proven esophageal cancer (adeno-, or squamous cell carcinoma) of the mid or distal esophagus or stage III NSCLC (any histological subtype).
• Scheduled for external-beam photon radiotherapy with curative intention.
• WHO 0-2.
• Age \>= 18 years
• Written informed consent.

You may not qualify if:

• Serious respiratory distress

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 14, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)