No registrations found.
ID
Source
Brief title
Health condition
Lung cancer, re-irradiation, thorax
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall survival
Secondary outcome
- Local control
- Disease-free survival
- Acute and late toxicity
- Cumulative dose to the organs at risk
- Quality of life
Background summary
Currently, patients with recurrent lung cancer who will get re-irradiation, are treated with low dose radiotherapy. However, reirradiation with modern techniques and dose summation of previous treatment plan allows us currently to give higher radiation dose, even up to a dose of 45 to 60 Gy, and therefore a radical treatment can be given.
Within this study we want to investigate if a dose of 45 to 60 can prolong the overall survival in patients with recurrent lung cancer.
Patients of 18 years or older with recurrent lung cancer in the thorax who have been irradiated previously to the same region are included. The
patients have the tumor close (5 cm or less) to the high dose region (50 Gy EQD2 or more). The minimal interval between initial treatment with curative intent and reirradiation has to be 9 months. Treatment in radical setting (at least 45 Gy EQD2) must be possible. Patients having more than 3 (oligo)metastases and/or (oligo)metastases in more than 2 organs and/or (oligo)metastases which can not be treated locally, are not a candidate.
The primary endpoint of the study is survival, our goal is to reach a median overall survival of 12 months. The secondary endpoint are local control, disease-free survival, acute and late toxicity and cumulative dose to the organs at risk.
Study objective
By giving high dose, radical, radiotherapy to patients with recurrent lung cancer, the
overall survival can be prolonged and local control rate can be increased which can be done with acceptable toxicity for the irradiated normal tissues.
Study design
Pre-treatment evaluation (screening)
Pre-study entry (baseline)
Radiotherapy treatment (period is different for each patients; maximum of 35 fractions)
FU visit 1: 1 week after re-RT
FU visit 2 (by phone): 3 weeks after re-RT
FU visit 3: 12 weeks after re-RT
FU visit 4: 6 months after re-RT
FU visit 5: 9 months after re-RT
FU visit 6: 12 months after re-RT
FU visit 7: 18 months after re-RT
FU visit 8: 24 months after re-RT
FU visit 9: 30 months after re-RT
FU visit 10: 36 months after re-RT
Intervention
Radiotherapy
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7052 |
| NTR-old | NTR7257 |
| Other | : METC: MEC-2017-534 / ABR: NL59876.078 |