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Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC (NVALT11)

Primary Purpose

Non Small Cell Lung Cancer (NSCLC), Radical Treatment, Stage III Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Prophylactic Cranial Irradiation
Sponsored by
Maastricht Radiation Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology)
  • Whole body FDG-PET-scan before start of therapy available: No distant metastases
  • CT or MRI of the brain before the start of radical therapy available: No brain metastases
  • Platinum-based chemotherapy is mandatory
  • Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery
  • Radiotherapy dose without surgery at least a biological equivalent of 60Gy
  • No prior cranial irradiation
  • Patients must sign a study-specific informed consent at the time of registration

Exclusion Criteria:

  • The opposite of the above

Sites / Locations

  • Maastro Clinic
  • The Netherlands Cancer Institute
  • VU Medical Center
  • RT Insitute Stedendriehoek
  • UMCG Groningen
  • St. Antonius Ziekenhuis
  • Dr. Bernard Verbeeten Institute
  • UMC Utrecht
  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prophylactic Cranial Irradiation

Observation

Arm Description

Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.

Outcomes

Primary Outcome Measures

Proportion of patients developing symptomatic brain metastasis

Secondary Outcome Measures

Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
Measurement of side effects (CTCAE3.0)
Quality of Life
Measured by QLQ-C30 and EuroQol 5D

Full Information

First Posted
January 24, 2011
Last Updated
April 9, 2015
Sponsor
Maastricht Radiation Oncology
Collaborators
University Medical Center Groningen, The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01282437
Brief Title
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC
Acronym
NVALT11
Official Title
Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht Radiation Oncology
Collaborators
University Medical Center Groningen, The Netherlands Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.
Detailed Description
For this group of patients, brain metastases are one of the major sites of tumor failure. Radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. PCI has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. Therefore this study is launched, in order to investigate whether PCI should become the standard of care in patients with stage III NSCLC who are treated with curative intention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (NSCLC), Radical Treatment, Stage III Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic Cranial Irradiation
Arm Type
Experimental
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Cranial Irradiation
Intervention Description
18 fractions of 2Gy 12 fractions of 2.5Gy 10 fractions of 3 Gy
Primary Outcome Measure Information:
Title
Proportion of patients developing symptomatic brain metastasis
Time Frame
24 months after randomisation
Secondary Outcome Measure Information:
Title
Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
Time Frame
24 months after randomisation
Title
Measurement of side effects (CTCAE3.0)
Time Frame
24 months after randomisation
Title
Quality of Life
Description
Measured by QLQ-C30 and EuroQol 5D
Time Frame
24 months after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology) Whole body FDG-PET-scan before start of therapy available: No distant metastases CT or MRI of the brain before the start of radical therapy available: No brain metastases Platinum-based chemotherapy is mandatory Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery Radiotherapy dose without surgery at least a biological equivalent of 60Gy No prior cranial irradiation Patients must sign a study-specific informed consent at the time of registration Exclusion Criteria: The opposite of the above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ruysscher, MD, PhD
Organizational Affiliation
NVALT oncology foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry Groen, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastro Clinic
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ET
Country
Netherlands
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Facility Name
VU Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
RT Insitute Stedendriehoek
City
Deventer
Country
Netherlands
Facility Name
UMCG Groningen
City
Groningen
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Institute
City
Tilburg
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31733490
Citation
Witlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14.
Results Reference
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Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC

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