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

NCT ID: NCT01282437

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prophylactic Cranial Irradiation

Group Type: EXPERIMENTAL

Prophylactic Cranial Irradiation

Intervention Type: RADIATION

• 18 fractions of 2Gy
• 12 fractions of 2.5Gy
• 10 fractions of 3 Gy

Observation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prophylactic Cranial Irradiation

• 18 fractions of 2Gy
• 12 fractions of 2.5Gy
• 10 fractions of 3 Gy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk De Ruysscher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NVALT oncology foundation

Harry Groen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

VU Medical Center

Amsterdam, Amsterdam, Netherlands

Maastro Clinic

Maastricht, Limburg, Netherlands

UMCG Groningen

Groningen, Provincie Groningen, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

The Netherlands Cancer Institute

Amsterdam, , Netherlands

RT Insitute Stedendriehoek

Deventer, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Dr. Bernard Verbeeten Institute

Tilburg, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 31733490 (View on PubMed)

Other Identifiers

NVALT11

Identifier Type: -

Identifier Source: org_study_id