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Reirradiation in the thoracic region

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20632
Enrollment
63
Registered
2018-06-04
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Lung cancer, re-irradiation, thorax

Interventions

Radiotherapy

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Cytological or histological proof of the current tumor: NSCLC or large cell lung cancer with neuro-endocrine differentiation; • Current tumor located close (5 cm or less) to the high dose region (50 Gy EQD2 or more) of the previous radiation; • Interval between initial treatment with curative intent and reirradiation is ≥9 months; • Age ≥ 18 years; • If woman of childbearing potential: use of adequate contraceptive precautions; • Written informed consent; • FEV1 > 40% of predicted; • Karnofsky score ≥ 70; • Treatment in radical setting (at least 45 Gy EQD2) is possible according to the local investigator; • Staging of recurrent lung cancer is performed with a whole body CT scan and PET scan; • Treatment options for the patient will be discussed at multidisciplinary oncology board.

Exclusion criteria

Exclusion criteria: • Pregnancy; • 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; • Contraindication to use intravenous CT contrast; • The use of radiosensitizers such as plaquenil; • 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.

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
- Local control - Disease-free survival - Acute and late toxicity - Cumulative dose to the organs at risk - Quality of life

Contacts

Public ContactM. Duijm
m.duijm@erasmusmc.nl06-50033538

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)