The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)

NCT05267158 | Recruiting

• 1 other identifier: NL67206.041.18
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of brain metastases is expected to increase because of better treatments of primary tumours. Novel diagnostic and therapeutic techniques are continuously being developed, all of which need thorough evaluation before they can be implemented in clinical routine. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting. .The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard. This design will speed up the process of translating treatment innovations to the daily clinic.

Conditions

Brain Metastases, Adult; Brain Neoplasms, Adult, Malignant

Keywords

radiotherapy (RT); QoL,Quality of life; Neurocognition; Brain metastases; Cranial irradiation; Neoplasm metastasis; Prognosis; Survival; Prospective

Outcome Measures

Primary Outcomes (4)

• Survival

  Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Basisregistratie Personen (BRP))

  Through study completion, an average of 1 year

• Time and Type of re-intervention

  Re-intervention (re-irradiation, surgery, other); Development of neurological symptoms; Development of new metastases.

  Through study completion, an average of 1 year

• Change in toxicity after radiotherapy

  The toxicity will be reported by using the serious adverse event (SAE) questionnaire, every 6 months

  Through study completion, an average of 1 year

• Technical and treatment data

  Dose, fractions and technique of radiotherapy. All other planned and/or received treatment for brain metastases and primary tumour (i.e. systemic therapy, surgery, radiotherapy), and the characteristics there of (type, dose, duration, awake surgery, extent of surgery, complications) \- Use of epileptic drugs, including type and dose

  Through study completion, an average of 1 year

Secondary Outcomes (10)

• Change in patient reported outcomes; general quality of life

  Through study completion, an average of 1 year

• Change in patient reported outcomes; cancer related fatigue

  Through study completion, an average of 1 year

• Change in patient reported outcomes; depression and anxiety

  Through study completion, an average of 1 year

• Change in patient reported outcomes; disease-specific symptoms of brain metastases and (adverse) effects of their treatment

  Through study completion, an average of 1 year

• Change in caregiver reported outcomes: general quality of life

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are referred to the Department of Radiotherapy for treatment of brain metastases or for prophylactic cranial irradiation (PCI) will be asked to participate in this cohort study.

You may qualify if:

• Age ≥ 18 years;
• Either radiographic and/or histologic proof of metastatic brain disease, or eligible for prophylactic cranial irradiation;
• Referred to the Department of Radiotherapy for cranial irradiation.

You may not qualify if:

• Mental disorder or cognitive dysfunction that hinder the patient's ability to understand the informed consent procedure and/or study details;
• Patients with severe psychiatric disorders;
• Inability to understand the Dutch language.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

RECRUITING

Related Links

• Coimbra Cohort (in Dutch)

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joost JC Verhoeff, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost JC Verhoeff, MD, PhD

CONTACT

+31-88-7564393; j.j.c.verhoeff-10@umcutrecht.nl

Fia F Cialdella

CONTACT

+31631118339; f.cialdella@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Radiation Oncologist

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: March 4, 2022
• Study Start: April 26, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2026
• Last Updated: September 6, 2022

Record last verified: 2022-08

Locations

NL (1)