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CompletedNCT01166204Updated May 23, 2017

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)

A Phase 2 interventional study of Radiotherapy in Stage I-III Non-small Cell Lung Cancer, sponsored by Maastricht Radiation Oncology. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by Maastricht Radiation Oncology · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2009, registered Jul 2010).
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Stage I-III Non-small Cell Lung Cancer

Keywords

  • Radiotherapy
  • NSCLC
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 300 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Maastricht Radiation Oncology is the lead sponsor of 104 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Single group

    Radiation: Radiotherapy

Interventions

  • RadiationRadiotherapy

    Radiotherapy

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 2.3 and 5 years

Secondary outcomes

  1. Progression-free survival

    Time frame: 2.3 and 5 years

  2. Dyspnea (CTCAE 4.0)

    Time frame: 2.3 and 5 years

  3. Dysphagia (CTCAE 4.0)

    Time frame: 2.3 and 5 years

  4. Patterns of recurrence

    Time frame: 2.3 and 5 years

07

Study locations

1 site
  • MAASTRO clinic
    Maastricht, Limburg 6229 ET, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01166204
Lead sponsor
Maastricht Radiation Oncology
Responsible party
Sponsor
First posted
Jul 20, 2010
Start date
May 2009
Primary completion
May 2017
Completion
May 2017
Last update
May 23, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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