Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsNA

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

NCT ID: NCT04790253

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Prophylactic cranial irradiation (radiation)
How long the study runs
Study runs about 66 months (dates as stated)
About the drug or intervention
Prophylactic cranial irradiation — radiation: Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the European Organisation for Research and Treatment of Cancer (EORTC), is for people with small-cell lung cancer that has not spread to the brain after standard treatment. It compares two approaches: preventive radiotherapy to the brain or regular check-ups using magnetic resonance imaging (MRI) scans to watch for cancer spreading to the brain.

Who can take part

  • Adults aged 18 or over with a confirmed diagnosis of small-cell lung cancer, at limited or extensive stage
  • Have finished standard treatment (chemotherapy, with or without radiotherapy or surgery) with no sign that the cancer has grown
  • No cancer spread to the brain or the tissues around it, confirmed by scans within 28 days before joining
  • Joining within 8 weeks of the last cycle of chemotherapy
  • Able to carry out day-to-day activities with little or some help (performance status score of 2 or below)
  • Kidney function good enough (creatinine clearance of at least 30 mL/min)
  • If able to become pregnant, a negative pregnancy test and use of highly effective contraception during treatment and for 30 days after; breastfeeding must stop before treatment starts
  • Willing and able to attend study visits and follow-up, and to give written informed consent

Who may not be able to

  • Previous radiotherapy to the brain or whole brain (some exceptions for past targeted radiosurgery for non-cancerous conditions may be considered case by case)
  • Allergy or other reaction to MRI contrast dye or tracers, or inability to have an MRI (for example, metal implants)
  • Another cancer needing treatment now
  • Ongoing side effects from previous treatment that are worse than mild at the time of joining
  • Serious health problems, such as heart attack or unstable angina in the past 6 months, serious liver disease, or an infection needing treatment at the time of joining
  • HIV with a CD4 count below 200 cells per microlitre (people with HIV on treatment and a CD4 count of 200 or above may join)
  • Severe neurological or mental health conditions needing treatment, such as dementia or epilepsy
  • Any personal, family or living situation that might make it hard to follow the study schedule

What taking part involves

  • • Being placed by chance (randomised) into one of two groups: preventive radiotherapy to the brain, or active monitoring with regular MRI scans
  • • Regular MRI scans of the brain and scans of the chest, abdomen and pelvis (computed tomography (CT) or MRI)
  • • Follow-up visits and examinations throughout the study

Time commitment: Taking part involves attending scheduled visits, having treatment (if in the radiotherapy group) and regular MRI scans and check-ups for the whole study period — exact number of visits and total duration: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
600
Started
2022-10-27
Last checked
2023-11

Plain English Summary

What is this study?

  • • Testing a new treatment for limited stage small cell lung cancer
  • • NA - 600 participants
  • • In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with limited stage small cell lung cancer

Where?

  • • Bristol - University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
  • • Edinburgh - NHS Lothian - Western General Hospital
  • • Maidstone - Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
  • • Manchester - The Christie NHS Foundation Trust
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

More detail

The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: * To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. * To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. * To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. * To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. * To compare brain-metastasis-free survival (BMFS) between the arms. * To compare progression free survival (PFS) between the arms. * To compare time to brain-metastasis-attributed death (TBMAD) between the arms. * To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. * To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. * To collect blood for biobanking.

Limited Stage Small Cell Lung CancerExtensive-stage Small-cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negativeCD4HIV positive

Treatment history

Treatments you must have had:

  • ✓ a negative serum pregnancy test within 3 days

What the study is looking for

  • ✓Age ≥ 18 years
  • ✓Histologically/cytologically proven diagnosis of SCLC
  • ✓Limited and extensive stage
  • ✓ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have...
  • ✓Completed standard therapy prior to randomization:

Who cannot take part

  • ✗Other active blood or solid tumour cancer requiring current active treatment.
  • ✗Any unresolved toxicities from prior therapy (e.g., drug treatment, radiotherapy) greater than CTCAE grade 2...
  • ✗Patient with severe active other health conditions, defined as follows:
  • ✗Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
  • ✗Transmural myocardial infarction within 6 months prior to randomization
See the full criteria
Inclusion Criteria: * Age ≥ 18 years * Histologically/cytologically proven diagnosis of SCLC * Limited and extensive stage * LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan. * ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan. * Completed standard therapy prior to randomization: * For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated. * For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy o Immunotherapy concurrent with and/or adjuvant to standard therapy is allowed at the discretion of the treating physician. * Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), 28 days before randomization. * Absence of brain metastases or leptomeningeal disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), within 28 days before randomization. * Interval from day 1 of last cycle of chemotherapy to randomization of ≤8 weeks * ECOG PS ≤ 2 * Estimated creatinine clearance ≥ 30 mL/min as calculated using the MDRD formula * Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons. * Patients Women of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the entire period of the radiotherapy treatment study participation and for at least 30 days after the last dose of radiotherapy. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include: * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient) * Female subjects who are breast feeding should discontinue nursing prior to the first dose of radiotherapy and during the entire period of the radiotherapy treatmentuntil 30 days after the administration of the last dose of radiotherapy. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up * Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization. * Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies. * Other active hematologic or solid tumour malignancy requiring current active treatment. * Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization. * Patient with severe active comorbidities, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization * Transmural myocardial infarction within 6 months prior to randomization * Acute infection requiring treatment at the time of randomization * Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization * Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease * HIV positive with CD4 count \< 200 cells/microliter. Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 16 weeks prior to randomization. * Any severe comorbidity that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration. * Severe neurological (including dementia and epilepsy) or psychiatric disorder requiring active treatment. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

Where Is This Study? (7 UK sites)

University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

Bristol BS2 8ED, United Kingdom

Recruiting
Site contact (verified)
Gareth Ayre, MDPrincipal Investigator

NHS Lothian - Western General Hospital

Edinburgh EH4 2XU, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Kirsty MacLennan, MDPrincipal Investigator

Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital

Maidstone ME16 9QQ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Timothy Sevitt, MDPrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Corinne Faivre-Finn, MDPrincipal Investigator

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Kerstie Johnson, MDPrincipal Investigator

Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Matthew Hatton, MDPrincipal Investigator

Royal Marsden Hospital - Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Fiona McDonald, MDPrincipal Investigator

How to Get in Touch

EORTC Reception

Sponsor contact

CONTACT

+3227741611 eortc@eortc.org
Data sourced from ClinicalTrials.gov · Last verified: 2023-11