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

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT01282437

Collaborator

University Medical Center Groningen (Other), The Netherlands Cancer Institute (Other)

315

Enrollment

Locations

Arms

73.9

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer (NSCLC) Radical Treatment Stage III Non-Small Cell Lung Cancer	Radiation: Prophylactic Cranial Irradiation	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

315 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of patients developing symptomatic brain metastasis [24 months after randomisation]

Secondary Outcome Measures

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 [24 months after randomisation]
Measured by QLQ-C30 and EuroQol 5D

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastro Clinic	Maastricht	Limburg	Netherlands	6229 ET
2	The Netherlands Cancer Institute	Amsterdam		Netherlands
3	VU Medical Center	Amsterdam		Netherlands
4	RT Insitute Stedendriehoek	Deventer		Netherlands
5	UMCG Groningen	Groningen		Netherlands
6	St. Antonius Ziekenhuis	Nieuwegein		Netherlands
7	Dr. Bernard Verbeeten Institute	Tilburg		Netherlands
8	UMC Utrecht	Utrecht		Netherlands
9	Isala Klinieken	Zwolle		Netherlands

Sponsors and Collaborators

Maastricht Radiation Oncology
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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht Radiation Oncology

ClinicalTrials.gov Identifier:

NCT01282437

Other Study ID Numbers:

NVALT11

First Posted:

Jan 25, 2011

Last Update Posted:

Apr 10, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 10, 2015