Non Small Cell Lung Cancer (NSCLC)Phase 3NVALT11NCT01282437
Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC
A Phase 3 study testing Prophylactic Cranial Irradiation in people with Non Small Cell Lung Cancer (NSCLC) and Radical Treatment, run by Maastricht Radiation Oncology at 9 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC), Radical Treatment, Stage III Non-Small Cell Lung Cancer
- What is being tested?
- Prophylactic Cranial Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 9 sitesNetherlands
- Study dates
- Jan 2009to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The opposite of the above
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
VU Medical Center
Amsterdam, Amsterdam
The Netherlands Cancer Institute
Amsterdam
RT Insitute Stedendriehoek
Deventer
UMCG Groningen
Groningen, Provincie Groningen
Maastro Clinic
Maastricht, Limburg, 6229 ET
St. Antonius Ziekenhuis
Nieuwegein
Dr. Bernard Verbeeten Institute
Tilburg
UMC Utrecht
Utrecht, Utrecht
Isala Klinieken
Zwolle
About this study
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.
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.
Read the 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
- Being tested
- Prophylactic Cranial Irradiation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Cranial IrradiationRadiation
- 18 fractions of 2Gy
- 12 fractions of 2.5Gy
- 10 fractions of 3 Gy
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Cranial Irradiation | Experimental | Not described Receives: Radiation: Prophylactic Cranial Irradiation |
| Observation | No intervention | Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing symptomatic brain metastasis
Measured: 24 months after randomisation
Secondary outcomes (3)
Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
Measured: 24 months after randomisation
Measurement of side effects (CTCAE3.0)
Measured: 24 months after randomisation
Quality of Life
Measured by QLQ-C30 and EuroQol 5D
Measured: 24 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2009
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk De Ruysscher, MD, PhD, Principal investigator, NVALT oncology foundationHarry Groen, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282437
- Sponsor's protocol ID
- NVALT11
- Acronym
- NVALT11
- Status last verified
- Apr 2015
- First submitted
- 24 Jan 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31733490
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01282437
- Acronym / sponsor ID
- NVALT11 / NVALT11
- Conditions
- Non Small Cell Lung Cancer (NSCLC), Radical Treatment, Stage III Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, The Netherlands Cancer Institute
- Study start
- Jan 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Cranial Irradiation | Experimental | Radiation: Prophylactic Cranial Irradiation |
| Observation | No intervention | –Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- The opposite of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic Cranial Irradiation* 18 fractions of 2Gy * 12 fractions of 2.5Gy * 10 fractions of 3 Gy | Radiation | Prophylactic Cranial Irradiation |
Primary outcome
Proportion of patients developing symptomatic brain metastasis
Time frame: 24 months after randomisation
3 secondary outcomes
Time to develop neurological symptoms (confirmed or unconfirmed by imaging)
Time frame: 24 months after randomisation
Measurement of side effects (CTCAE3.0)
Time frame: 24 months after randomisation
Quality of Life
Time frame: 24 months after randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Derived from this study: PubMed 31733490Witlox 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk De Ruysscher, MD, PhD principal investigator
NVALT oncology foundation
Harry Groen, MD, PhD principal investigator
University Medical Center Groningen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prophylactic Cranial Irradiation in people with Non Small Cell Lung Cancer (NSCLC) and Radical Treatment, run by Maastricht Radiation Oncology at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients developing symptomatic brain metastasis (time frame: 24 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.