Adaptive Radiotherapy in Non-small Cell Lung Cancer (NSCLC)
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Purpose
The investigators group uses an individualised radiation dose approach in which the dose is escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is 69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose) constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the investigators will adapt the treatment by performing a new (PET)-CT at day 12 during radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be increased.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Other: Radiotherapy and concurrent chemo-therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Adaptive Radiotherapy for Stage II-III Non-small Cell Lung Cancer |
- Proportion of patients able to receive 69Gy as TTD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Dyspnea (CTCAE 4.0) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Dysphagia (CTCAE 4.0) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Patterns of recurrence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Radiotherapy |
Other: Radiotherapy and concurrent chemo-therapy
Radiotherapy and concurrent chemo-therapy
|
Detailed Description:
Eligible patients will receive concurrent chemo-radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/- 1Gy, irrespective of lung function.
Other dose constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy.
In concurrent with chemotherapy, radiotherapy will be delivered as follows:
- First three weeks /30 fractions:twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions.
- Thereafter: once-daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.
In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.
Chemotherapy schedules allowed:
- 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.
Concurrent part: (day 1=first day of radiotherapy)
- cisplatin-vinorelbine
- cisplatin-docetaxel
- cisplatin-etoposide
- cisplatin-pemetrexed in non-squamous histologies
Q3 week; 3 cycles
When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin.
In case the TTD(Total Treatment Dose)=69Gy cannot be reached because of a limiting MLD, a FDG-PET-CT will be performed at day 12 during radiotherapy. GTV's (Gross Tmor Volume), CTV's (Clinical Target Volume) and PTV's (Planning Target Volume) will be delineated and a new plan calculated. The endpoint will be the proportion of patients that will receive 69Gy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological proven NSCLC
- UICC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment
- Performance status 0-2
- IMRT technique
Exclusion Criteria:
- Not NSCLC of mixed NSCLC and other histologies (e.g. small cell carcinoma)
- Stage IV, except for solitary (<6) metastases
- Performance status 3 or more
Contacts and Locations| Netherlands | |
| MAASTRO clinic | Recruiting |
| Maastricht, Limburg, Netherlands, 6229 ET | |
| Contact: Dirk De Ruysscher, MD, PhD +31 88 4455700 dirk.deruysscher@maastro.nl | |
| Contact: Wouter van Elmpt, PhD, MSc. +31 88 4455783 wouter.vanelmpt@maastro.nl | |
| Principal Investigator: Dirk DeRuysscher, MD, PhD | |
| Principal Investigator: Wouter van Elmpt, PhD, MSc. | |
More Information
No publications provided
| Responsible Party: | Maastricht Radiation Oncology |
| ClinicalTrials.gov Identifier: | NCT01207063 History of Changes |
| Other Study ID Numbers: | BRONC CONC MLD/BRONC MLD/ADA |
| Study First Received: | July 26, 2010 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Maastricht Radiation Oncology:
|
Radiotherapy NSCLC Stage II-III non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013