Skip to main content
OpenTrials
Completed

NCT Number: NCT01166204

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

About this study

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:

  • 1-2 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 Q 3 weeks; 3 cycles

When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Radiotherapy

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

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2010
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.