Reirradiation for recurrent lung cancer in the thorax: overall survival, local control, and toxicity: a phase 2 trial

Recruiting

• Conditions: lung carcinoma; lungcancer; 10038666

• Registration Number: NL-OMON50584
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 63

Inclusion Criteria

The patients have the tumor close (5 cm or less) to the high dose region (50 Gy
EQD2 or more) of the previous irradiation.
Minimal interval between initial treatment with curative intent and
reirradiation of 9 months. Treatment in radical setting (at least 45 Gy EQD2)
must be possible according to the local investigator.
Treatment options for the patient will be discussed at multidisciplinary
oncology board.
Karnofsky score * 70

Exclusion Criteria

Patients with more than 3 (oligo)metastases and/or (oligo)metastasis in more
than 2 organs and/or (oligo)metastasis which cannot be treated locally.
Inability to retrieve the previous radiation fields, total dose, dose per
fraction and time of first radiation series and DVH of the organs at risk.
Not possible to use intervenous CT-contrast.
Pregnant woman.
The use of radiosensitizers such as plaquenil.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to determine the overall survival. In<br /><br>previous studies, the median overall survival was 3 to 8 months, with a median<br /><br>of 6 months. The goal of this study is to treat recurrent lung cancer with high<br /><br>dose radiotherapy to reach a median overall survival of 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints will be the local control and disease-free survival.<br /><br>Other secondary endpoints are the acute and late toxicity, and the cumulative<br /><br>dose to the organs at risk.</p><br>