The objective of the study is to give a dose of 45 to 60 Gy and therefore to prolong the survival in patients with recurrent lung cancer.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
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.
Study objective
The objective of the study is to give a dose of 45 to 60 Gy and therefore to
prolong the survival in patients with recurrent lung cancer.
Study design
Observational study, phase 2
Intervention
not applicable
Study burden and risks
In general, patients are fatigued throughout a radiotherapy treatment period.
The patient can have a dry or productive cough during or shortly after the
radiation course. The patients can have pain with swallowing and a loss of
appetite. Symptomatic medication as anti-emetics and pain medication will be
provided if required. Five to ten percent of the patients are not able to feed
themselves adequately due to severe pain and these patients will be treated
with an admission and a placement of a feeding tube. Severe late radiation
pneumonitis occuring at 4 - 8 months after the treatment is described and is
diagnosed in 10% of the patients and these patients are treated with
antibiotics and corticosteroids.
Depending on the technique: 3-D conformal radiotherapy, IMRT, or stereotactic
radiotherapy the patient will receive 3 to 35 fractions. With this treatment,
the patient will receive a radical treatment instead of a low dose treatment.
In comparison with the most commonly used low dose radiation schedule (5 x
4Gy), the patient has to come an extra 30 times to the hospital for irradiation.
Because of the study treatment, the follow-up visits are more frequent. In case
of low dose radiation, patients will come to the Radiation-Oncologist at 1 and
2 months after treatment and will be referred back to the pulmonologist
afterwards. In case of the study-treatment, the patient will visit the hospital
more frequently often combined with a CT-scan. In total patients will visit the
hospital 8 times extra in combination with a CT scan in 5 follow-up moments.
In summary, the patient will be 43 times extra in the hospital. If we use 30
minutes for each kind of extra visit, the burden may reach 21.5 hours assuming
complete follow-up of the patient
Groene Hilledijk 301
Rotterdam 3075 AE
NL
Groene Hilledijk 301
Rotterdam 3075 AE
NL
Listed location countries
Age
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.
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 |
|---|---|
| CCMO | NL59876.078.17 |