This randomized phase III study is designed to investigate whether PCI could reduce the incidence of brain metastases or delay their appearance in patients with stage III NSCLC who are treated with curative intention.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be followed for development of symptomatic brain metastases.
Secondary outcome
Secundary endpoints are: side effects, survival, quality of life (QLQ-C30 and
EuroQol 5D), quality adjusted survival (QALYs) and health care costs.
Background summary
At present brain metastases are one of the major sites of tumor failure in
patients with stage III non-small cell lung cancer (NSCLC). Radical therapy of
symptomatic brain metastasis is seldom possible and only very rarely, long-term
survival can be achieved.
Prophylactic cranial irradiation (PCI) has been shown to reduce the incidence
of brain metastases in patients with NSCLC to the same extent as in limited
disease small-cell lung cancer. However, the exact value of PCI in properly
staged III NSCLC patients, treated with contemporary chemoradiation schedules
with or without surgery, remains unsettled.
Study objective
This randomized phase III study is designed to investigate whether PCI could
reduce the incidence of brain metastases or delay their appearance in patients
with stage III NSCLC who are treated with curative intention.
Study design
A total of 300 patients will be randomized in this study after radical
treatment receive to PCI or control. The PCI dose is left to the choice of the
participating hospitals, either 36 Gy in 18 fractions, 30 Gy in 12 fractions or
30 Gy in 10 fractions. Patients will be registered into the study before
randomizing, and patients progressing after the treatment for their lung cancer
will not be randomized into the study. About 450 patients will be registered.
Intervention
The PCI dose is left to the choice of the participating hospitals, either 36 Gy
in 18 fractions, 30 Gy in 12 fractions or 30 Gy in 10 fractions.
Study burden and risks
Standard side effects of cranial irradiation
c/o Prof. H. J.M. Groen, UMCG, p.o Box 30.001
9700 RB Groningen,
NL
c/o Prof. H. J.M. Groen, UMCG, p.o Box 30.001
9700 RB Groningen,
NL
Listed location countries
Age
Inclusion criteria
4.1 Eligibility for registration
1. UICC stage III A or IIIB (without malignant pleural or pericardial effusion) non-small cell lung cancer (histology or cytology)
2. Whole body FDG-PET-scan before the start of therapy available: No distant metastases
3. CT or MRI of the brain before the start of therapy available: No brain metastases
4. No other malignancy in the preceding 2 years, except non-melanoma skin cancer or any carcinoma in situ.
5. No prior cranial irradiation
6 Patient should be suitable for radical treatment with Platinum-based chemotherapy and is planned to receive radical loco-regional therapy: concurrent or sequential chemotherapy (Platinum-based) and radiotherapy with or without surgery (Radiotherapy dose without surgery at least a biological equivalent of 60 Gy (20))
7. Patients must sign a study-specific informed consent at the time of registration. At the same time, thus before randomization, the baseline forms (CTCAE3.0, QLQ-C30 and EuroQol 5D) should be filled out.
8. Pregnant women are ineligible as treatment involves unforeseen risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception
4.2 Conditions for Patient eligibility at randomization
1. Patient has been registered in the study and has completed appropriate radical treatment, no more than 6 weeks before. Registration is thus allowed either before or after radical therapy.
2 The patient is ready to receive PCI within 1 week of randomization (if randomized to PCI arm)
3. There is no clinical evidence of progressive disease after chemo-radiation (no imaging is requested)
4. No evidence of extracranial distant metastatic disease
5. Signed informed consent for randomization
Exclusion criteria
n.a.
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 | NL23105.068.08 |