Concurrent Chemo-radiation Form NSCLC to a Individualized... | NCT00572325

Studies
Concurrent Chemo-radiation Form NSCLC to a Individualized MLD

NCT00572325

Sponsor

Maastricht Radiation Oncology

Status

Completed

Last Update Posted

Jul 21, 2010Estimated

Enrollment

180Actual

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2010

Last Update Posted Date

Jul 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):

MLD=19 Gy when Fev1 and DLCO>50% of the predicted value
MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
MLD=10 Gy when Fev1 and/or DLCO <40% of the predicted value

Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:54 Gy. Maximal tumor dose:69 Gy

Radiotherapy will be delivered as follows:

First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.

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 type will be registered.
concurrent part:(day1= first day of radiotherapy)
1. cisplatin - vinorelbine
  - Cisplatin 50 mg/m2 day 2 and day 9
  - Vinorelbine 20 mg/m2 day 2 and day 9
  - Cisplatin 40mg/m2 day 23
  - Vinorelbine 15mg/m2 day 23 and day 30
2. cisplatin - docetaxel
  - Cisplatin 50 mg/m2 day 2,9 and 29
  - Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29
3. cisplatin - etoposide
  - Cisplatin 60 mg/m2 day 1
  - Docetaxel 120 mg/m2 day 1-3

Q 3 weeks, 3 cycles

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death		2,3 and 5 years

Secondary Outcomes

Measure	Description	Time Frame
-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence		2,3 and 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dirk De Ruysscher, MD,PhD	MAASTRO clinic, Maastricht Radiation Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MAASTRO clinic, Maastricht Radiation Oncology		Maastricht		6202 AZ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24044794	Derived	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.
22608261

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms