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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50584
Enrollment
63
Registered
2018-07-25
Start date
2018-09-26
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung carcinoma lungcancer

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is to determine the overall survival. In previous studies, the median overall survival was 3 to 8 months, with a median of 6 months. The goal of this study is to treat recurrent lung cancer with high dose radiotherapy to reach a median overall survival of 12 months.

Secondary

MeasureTime frame
The secondary endpoints will be the local control and disease-free survival. Other secondary endpoints are the acute and late toxicity, and the cumulative dose to the organs at risk.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)