to evaluate the role of thoracic irradiation in patients with ED-SCLC who respond to chemotherapy and to assess the effect on 1 year survival
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 year survival
Secondary outcome
toxicity
pattern of recurrent disease
Background summary
Chemotherapy is the cornerstone in the treatment of extensive disease small
cell lung cancer (ED-SCLC), and four to six cycles of chemotherapy without
maintenance therapy is current standard. However, survival in patients
presenting with ED-SCLC is poor and has shown little improvement in the past
few decades.
The notable exception was the survival benefit reported in a phase III EORTC
trial evaluating prophylactic cranial irradiation (PCI) versus no PCI following
any response to induction chemotherapy Symptomatic brain metastases were
significantly more frequent in controls (40% versus 15%), more of whom also
died of SCLC (80% versus 68%). More patients in the PCI arm also received
salvage chemotherapy at the time of disease recurrence. PCI is the new standard
of care in all patients with SCLC who respond to chemotherapy.
Intrathoracic tumor control is a major problem in ED-SCLC. Over 75% of patients
have persisting intra-thoracic disease after initial chemotherapy, and about
90% manifest intra-thoracic disease progression at 1 year after completing
initial chemotherapy In a trial reported by Jeremic et al., patients with
ED-SCLC who had a complete response at sites of distant disease, were
randomized to thoracic radiotherapy. The reported median and 5-year survivals,
was far higher than has been reported by any other group for ED-SCLC. This
study has not yet been repeated.
In the absence of promising systemic agents that can improve local response, a
logical step would be to evaluate the role of thoracic irradiation in patients
with ED-SCLC who respond to chemotherapy and to assess the effect on 1 year
survival.
Study objective
to evaluate the role of thoracic irradiation in patients with ED-SCLC who
respond to chemotherapy and to assess the effect on 1 year survival
Study design
This is a multicenter phase III randomized trial. Patients with cytologically or
histologically proven ED small cell lung cancer
will be treated with chemotherapy.
Patients with a response will receive prophylactic cranial irradiation and will
be randomized to receive either thoracic
irradiation or no further therapy
Intervention
thoracic irradiation
Study burden and risks
No extra hospital visists or interventions. Risk for extra toxicity due to
thoracic irradiation
De Boelelaan 1117
1087 HV Amsterdam
NL
De Boelelaan 1117
1087 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
18 years or older
Cytologically or histologically proven small cell lung cancer
Documented extensive disease before the start of chemotherapy
Any response after 4 to 6 cycles of initial chemotherapy
Exclusion criteria
prior radiotherapy to the brain or the thorax
evidence of brain metastases or leptomeningeal metastases, pleural metastases or pleuritis carcinomatosa
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 | NL24556.029.08 |