Concurrent Chemo-radiation Form NSCLC to a Individualized MLD

NCT00572325 | Completed

• 1 other identifier: BRONC CONCURR MLD
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy

Conditions

Non-small Cell Lung Cancer

Keywords

radiotherapy; NSCLC; stage III non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• death

  2,3 and 5 years

Secondary Outcomes (1)

• -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence

  2,3 and 5 years

Study Arms (1)

1

Inclusion criteria * Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) * stage IV * performance status 3 or more * FeV 1 or DLCO\< 30% of the age-predicted value

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV 1 and DLCO at least 30% of the age-predicted value

You may qualify if:

• Histological or cytological proven NSCLC
• UICC stage I-III
• Performance status 0-2
• FeV 1 and DLCO at least 30% of the age-predicted value

You may not qualify if:

• Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
• UICC stage IV
• Performance status 3 or more
• FeV 1 and DLCO \< 30% of the age-predicted value

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

MAASTRO clinic, Maastricht Radiation Oncology

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (3)

• Nalbantov G, Kietselaer B, Vandecasteele K, Oberije C, Berbee M, Troost E, Dingemans AM, van Baardwijk A, Smits K, Dekker A, Bussink J, De Ruysscher D, Lievens Y, Lambin P. Cardiac comorbidity is an independent risk factor for radiation-induced lung toxicity in lung cancer patients. Radiother Oncol. 2013 Oct;109(1):100-6. doi: 10.1016/j.radonc.2013.08.035. Epub 2013 Sep 14.

  PMID: 24044794 DERIVED

• van Baardwijk A, Reymen B, Wanders S, Borger J, Ollers M, Dingemans AM, Bootsma G, Geraedts W, Pitz C, Lunde R, Peters F, Lambin P, De Ruysscher D. Mature results of a phase II trial on individualised accelerated radiotherapy based on normal tissue constraints in concurrent chemo-radiation for stage III non-small cell lung cancer. Eur J Cancer. 2012 Oct;48(15):2339-46. doi: 10.1016/j.ejca.2012.04.014. Epub 2012 May 18.

  PMID: 22608261 DERIVED

• Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, van der Weide H, Rao B, Lambin P. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-8. doi: 10.1016/j.ijrobp.2010.06.011. Epub 2010 Oct 1.

  PMID: 20888135 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dirk De Ruysscher, MD,PhD

  MAASTRO clinic, Maastricht Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: August 1, 2006
• Study Completion: May 1, 2009
• Last Updated: July 21, 2010

Record last verified: 2010-07

Locations

NL (1)