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Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)

Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01166204
Enrollment
300
Registered
2010-07-20
Start date
2009-05-31
Completion date
2017-05-31
Last updated
2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage I-III Non-small Cell Lung Cancer

Keywords

Radiotherapy, NSCLC

Brief summary

Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.

Detailed description

Eligible patients (see below) will receive 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 concurrence 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. 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered. 2. Concurrent part: (day 1 = first day of radiotherapy) * cisplatin - vinorelbine * cisplatin - docetaxel * cisplatin - etoposide * cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin

Interventions

RADIATIONRadiotherapy

Radiotherapy

Sponsors

Maastricht Radiation Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histological or cytological proven NSCLC * IUCC stage I-III, or solitary metastases (\<6), which are amendable for radical local treatment. * Performance status 0-2 * IMRT technique

Exclusion criteria

* Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) * Stage IV, except for solitary (\<6) metastases * Performance status 3 or more * No IMRT technique

Design outcomes

Primary

MeasureTime frame
Overall survival2.3 and 5 years

Secondary

MeasureTime frame
Progression-free survival2.3 and 5 years
Dyspnea (CTCAE 4.0)2.3 and 5 years
Dysphagia (CTCAE 4.0)2.3 and 5 years
Patterns of recurrence2.3 and 5 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026