Lung CancerPCINCT01603849
Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis
A study testing Prophylactic Cranial Irradiation in people with Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally advanced or metastatic disease. Important to mention the number of patients that progress or recur in central nervous system (CNS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- 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
- 84 participants
- Where
- 1 siteMexico
- Study dates
- May 2012to Jul 2020
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with histologically proven advanced NSCLC (Stage IIIB or IV) including wild-type, EGFR-mutated or ALK-rearrangements who received treatment and were without progression at the end.
- Above 18 years
- General status with a Karnofsky >80%
- Eastern Cooperative Group (ECOG) ≤2
- Negative CNS MRI at the beginning of any treatment
- Carcinoembryonic antigen > 20 pg
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- Hepatic and hematic cytology test within normal range
- Adequate renal function
- Those who accepted to participate in the study and who sign the letter of informed consent.
Who cannot join
- Patients with another type of cancer
- Patients who refuse participate in the protocol
- General status with a Karnofsky <80%
- Eastern Cooperative Group (ECOG) >2
- Previous treatment with WBRT
- Previous treatment with chemotherapy
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- Disease progression after initial treatment, either chemotherapy or chemoradiotherapy depending the case.
- CNS metastasis at diagnosis
- Abnormal laboratory test that interfere with chemotherapy or TKI administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally advanced or metastatic disease. Important to mention the number of patients that progress or recur in central nervous system (CNS). It has been reported that patients with adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with prophylactic cranial irradiation (PCI) is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to prove any survival benefit, only in CNS PFS, probably because there is no trial, to our knowledge, of PCI in NSCLC that include only the specific group of patients considered in high risk of developing brain metastasis.
Read the detailed description
Objectives:
- To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after locoregional or systemic treatment.
- Evaluate the benefit in OS in the specific group of patients who are at increased risk of developing brain metastasis
- Evaluate quality of life and mental function before and after treatment with PCI and compare it with patients in the observation group.
Methods: One hundred and twenty eight patients with locally advanced or metastatic (except CNS metastasis) NSCLC will be included and randomized to receive either observation or PCI 25 Gy in 10 fractions Whole Brain Radiotherapy (WBRT) once the initial treatment has been completed and progression of the disease ruled out.
- Conditions
- Lung Cancer
- Being tested
- Prophylactic Cranial Irradiation
- Keywords
- Prophylactic Cranial Irradiation, Lung Cancer, Non Small Cell Lung Cancer, Carcinoembryonic Antigen
- Medical subject headings
- Lung Neoplasms, 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
Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
| Study group | Role | What they receive |
|---|---|---|
| A Prophylactic Cranial Irradiation | Experimental | Patients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression. Receives: Radiation: Prophylactic Cranial Irradiation |
| B Observation Group | No intervention | Patients in this arm will be observed (not receiving WBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of brain metastases
From the day of randomization to the date when brain metastasis develop if this is the case.
Measured: 24 months
Secondary outcomes (3)
Overall Survival
From the day of randomization to the date of death if this is the case
Measured: 24 months
Quality of life as per QLQ-C30
a QLQ questionnaire from EORTC organization (spanish version) will be performed before, during and after PCI and will be compared with the observation group questionnaires.
Measured: 12 months
Mental function
A mini mental status examination will be performed before, during and after PCI and will be compared with the observation group questionnaires
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2019
- Study completionJul 2020
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 Lung CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar MD Arrieta, MD, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603849
- Sponsor's protocol ID
- pciHighRiskINCAN
- Acronym
- PCI
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2012
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Arrieta O, Maldonado F, Turcott JG, Zatarain-Barron ZL, Barron F, Blake-Cerda M, Cabrera-Miranda LA, Cardona AF, de la Garza JG, Rosell R. Prophylactic Cranial Irradiation Reduces Brain Metastases and Improves Overall Survival in High-Risk Metastatic Non-Small Cell Lung Cancer Patients: A Randomized phase 2 Study (PRoT-BM trial). Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1442-1450. doi: 10.1016/j.ijrobp.2021.02.044. Epub 2021 Feb 25.
PubMed 33640422
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
- ClinicalTrials.gov ID
- NCT01603849
- Acronym / sponsor ID
- PCI / pciHighRiskINCAN
- Conditions
- Lung Cancer
- Keywords
- Prophylactic Cranial Irradiation, Lung Cancer, Non Small Cell Lung Cancer, Carcinoembryonic Antigen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 23 May 2012 (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.
Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally advanced or metastatic disease. Important to mention the number of patients that progress or recur in central nervous system (CNS). It has been reported that patients with adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with prophylactic cranial irradiation (PCI) is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to prove any survival benefit, only in CNS PFS, probably because there is no trial, to our knowledge, of PCI in NSCLC that include only the specific group of patients considered in high risk of developing brain metastasis.
Detailed description
Objectives:
- To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after locoregional or systemic treatment.
- Evaluate the benefit in OS in the specific group of patients who are at increased risk of developing brain metastasis
- Evaluate quality of life and mental function before and after treatment with PCI and compare it with patients in the observation group.
Methods: One hundred and twenty eight patients with locally advanced or metastatic (except CNS metastasis) NSCLC will be included and randomized to receive either observation or PCI 25 Gy in 10 fractions Whole Brain Radiotherapy (WBRT) once the initial treatment has been completed and progression of the disease ruled out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Prophylactic Cranial Irradiation | Experimental | Radiation: Prophylactic Cranial IrradiationPatients will received PCI 25 Gy in 10 fractions WBRT 4 weeks after initial treatment in the absence of disease progression. |
| B Observation Group | No intervention | –Patients in this arm will be observed (not receiving WBRT) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients with histologically proven advanced NSCLC (Stage IIIB or IV) including wild-type, EGFR-mutated or ALK-rearrangements who received treatment and were without progression at the end.
- Above 18 years
- General status with a Karnofsky >80%
- Eastern Cooperative Group (ECOG) ≤2
- Negative CNS MRI at the beginning of any treatment
Key exclusion criteria (9 listed)
- Patients with another type of cancer
- Patients who refuse participate in the protocol
- General status with a Karnofsky <80%
- Eastern Cooperative Group (ECOG) >2
- Previous treatment with WBRT
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 IrradiationPatients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions. | Radiation | A Prophylactic Cranial Irradiation |
Primary outcome
Cumulative incidence of brain metastases
Time frame: 24 months
From the day of randomization to the date when brain metastasis develop if this is the case.
3 secondary outcomes
Overall Survival
Time frame: 24 months
Quality of life as per QLQ-C30
Time frame: 12 months
Mental function
Time frame: 12 months
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 27 Apr 2023.
- Derived from this study: PubMed 33640422Arrieta O, Maldonado F, Turcott JG, Zatarain-Barron ZL, Barron F, Blake-Cerda M, Cabrera-Miranda LA, Cardona AF, de la Garza JG, Rosell R. Prophylactic Cranial Irradiation Reduces Brain Metastases and Improves Overall Survival in High-Risk Metastatic Non-Small Cell Lung Cancer Patients: A Randomized phase 2 Study (PRoT-BM trial). Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1442-1450. doi: 10.1016/j.ijrobp.2021.02.044. Epub 2021 Feb 25.
- Individual participant dataSharing planned: No
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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.
Oscar MD Arrieta, MD principal investigator
Instituto Nacional de Cancerologia, Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Cranial Irradiation in people with Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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 9 inclusion and 9 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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.
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?
Cumulative incidence of brain metastases (time frame: 24 months). 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 NCT01603849, 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 27 Apr 2023.