NCT01207063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

7.4 years

First QC Date

July 26, 2010

Last Update Submit

August 16, 2018

Conditions

Non-small Cell Lung Cancer

Keywords

RadiotherapyNSCLCStage II-III non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients able to receive 69Gy as TTD

    3 months

Secondary Outcomes (5)

  • Overall survival

    3 months

  • Progression free survival

    3 months

  • Dyspnea (CTCAE 4.0)

    3 months

  • Dysphagia (CTCAE 4.0)

    3 months

  • Patterns of recurrence

    3 months

Study Arms (1)

Radiotherapy

EXPERIMENTAL
Other: Radiotherapy and concurrent chemo-therapy

Interventions

Radiotherapy and concurrent chemo-therapyOTHER

Radiotherapy and concurrent chemo-therapy

Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2010

First Posted

September 22, 2010

Study Start

March 1, 2011

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

NL(1)