Main:the objective of this randomized trial would be to study disease free survival (DFS) in a population with completely resected NSCLC with homolateral lymph node mediastinal involvement histological or cytological proven. Who will randomly be…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
disease free survival (DFS)
Secondary outcome
- assessment of treatment of acute and late toxicity (with identification of
predictiev factors of toxicity)
- local control
- patterns of recurrence
- overall survival
- second cancers
- prognostic and predictive factors on DFS and OS
Background summary
Over one million people are diagnosed with lung cancer every year throughout
the world. About 80% of them have non-small cell lung cancer (NSCLC) whtich
includes adenocarcinoma, squamous cell and large cell carcinoma. Considering
all stages together, the 5-year survival rate in NSCLC patients does not exceed
14%. Most long term survivors are patients having had a complete surgical
resection of their tumor. The latter, considerd as the best treatment option,
is only achievable in about 30% of the patients. Even in this highly selected
group of patients, there is still a high risk of both local and distant
failure. Adjuvant treatments such as chemotherapy (CT) and radiotherapy(RT)
have therefore been evaluated in order to improve their prognosis. In view of
the high proportion of the patients still suffering form local tumour
recurrence after a complete resection and adjuvant chemotherapy, a new interest
in post-operative radiotherapy (PORT) occurred. However, PORT has been for
years a very controversial issue and still is.
A new radomized study should take into consideration all we know about
toxicity. Conformational radiotherapy should be proposed to all operated
patients as their mediastinal location and anatomy may vary after surgery,
especially pneumectomy, in order to decrease the morbidity.
Study objective
Main:
the objective of this randomized trial would be to study disease free survival
(DFS) in a population with completely resected NSCLC with homolateral lymph
node mediastinal involvement histological or cytological proven. Who will
randomly be assigned to receive conformational PORT of not to receive PORT.
Local control will be studied carefully. Overall survial will be evaluated with
a minimal follow-up of 5 years in the two groups.
Secondary:
- impact of thoracic radiotherapy on toxicity and in particular cardiac and
pulmonary toxicity (with identification of plasmatic predictif factors of
toxicity)
- local control
- patterns of recurrence
- overall survival (OS)
- second cancers
- prognostic factors and predictiev faactors of treatment effect on DFS and OS.
Study design
Phase III multicentre international trial with possible individual direct
benefit to the patient comparing after randomization mediastinal PORT (54 Gy/30
fractions/ 6 weeks) to no PORT.
Intervention
Conformal postoperatiev thoracacic radiotherapty (PORT) in experimental arm.
PORT consists of 54 Gy in 30 fractions of 1,8 Gy. The radiotherapy will be
given one time a day, 5 days per week.
Study burden and risks
Possible benefits and risks
The benefit due to participation is that the patient will maybe avoid a
treatment which may not be proven effective after all. The randomization takes
care of at random allocation of the experimental treatment (radiotherapy after
surgery) or the standard treatment.
Another benefit of this trial is to gain more insight into the treatment of
lung cancer patients.
Possible side effects of radiotherapy are:
fatigue, pain during swallow, irratiation of the skin and severe coughing. In
the time period after the end of radiotherapy radiotion pneumonitis can be
occur. Patients may develop a less lower lung function after the treatment with
radiotherapy and can develop shortness of breath. The patient will be under
monitoring to prevent these side effects.
Dr. Tanslaan 12
6229 ET Maastricht
NL
Dr. Tanslaan 12
6229 ET Maastricht
NL
Listed location countries
Age
Inclusion criteria
1) Histological evidence of non-small cell lung cancer (NSCLC)
2) Complete resection with mediastinal lymph node exploration
3) Pathologically or cytologically documented mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint AJCC and UICC classification,
4) No past history of chest radiotherapy
5) Prior chemotherapy is allowed
6) Patient aged >18 years
7) WHO 0 or 1
8) Adequate pulmonary function
9) No severe cardiac or pulmonary disease,
10) Possibility of long-term follow-up
11) Information given to patient and signed informed consent form.
Exclusion criteria
1) Documented metastases,
2) Pleural or pericardial effusion,
3) Synchronous contra-lateral lung cancer,
4) Clinical progression during post-operative chemotherapy,
5) Incomplete resection
6) Lack of mediastinal lymph node exploration,
7) Previous chest radiotherapy
8) Intention of concomitant chemotherapy during radiotherapy
9) Weight loss before surgery more than 10%
10) Evidence of severe or uncontrolled systemic disease as judged by the investigator
11) Recent ( < 6 months) severe cardiac disease
12) Past or current history of neoplasm other than non-small cell lung cancer
13) Pregnancy or breast feeding or absence of adequate contraceptive measures during treatment
14) Patients who cannot be adequately followed up
15) Patient deprived of freedom or under guardianship.
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 |
|---|---|
| ClinicalTrials.gov | NCT00410683 |
| CCMO | NL23602.068.08 |