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

Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer (NSCLC); Stage III Non-Small Cell Lung Cancer; Radical Treatment
• Intervention / Treatment: Radiation: Prophylactic Cranial Irradiation

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.

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU Medical Center
  • Amsterdam, Netherlands
    • The Netherlands Cancer Institute
  • Deventer, Netherlands
    • RT Insitute Stedendriehoek
  • Groningen, Netherlands
    • UMCG Groningen
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis
  • Tilburg, Netherlands
    • Dr. Bernard Verbeeten Institute
  • Utrecht, Netherlands
    • UMC Utrecht
  • Zwolle, Netherlands
    • Isala Klinieken
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 ET
      • Maastro clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prophylactic Cranial Irradiation	Radiation: Prophylactic Cranial Irradiation; 18 fractions of 2Gy; 12 fractions of 2.5Gy; 10 fractions of 3 Gy
NO_INTERVENTION: Observation; Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients developing symptomatic brain metastasis	24 months after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to develop neurological symptoms (confirmed or unconfirmed by imaging)		24 months after randomisation
Measurement of side effects (CTCAE3.0)		24 months after randomisation
Quality of Life	Measured by QLQ-C30 and EuroQol 5D	24 months after randomisation

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Collaborators: University Medical Center Groningen; The Netherlands Cancer Institute
• Investigators: Principal Investigator: Dirk De Ruysscher, MD, PhD, NVALT oncology foundation; Principal Investigator: Harry Groen, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (ESTIMATE): January 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NVALT11