Watchful Observation of Patients With LD-SCLC Instead of the PCI

NCT04168281 | Unknown

• 1 other identifier: LD-SCLC_PCI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Prophylactic cranial irradiation (PCI) is a current standard of care after confirmed response to radical chemoradiotherapy for limited disease small cell lung cancer (LD-SCLC). This standard is mostly based on results of old randomized studies when brain imaging with magnetic resonance (MRI) was not available. Survival benefit of PCI in extended SCLC was recently challenged by results of randomized phase III study from Japan. We propose to carefully follow LD-SCLC patients with MRI instead of PCI in order to apply modern brain irradiation \[stereotactic radiotherapy (SRT) in eligible patients or whole brain radiation therapy (WBRT)\] to patients who develop metastases and to eliminate long terms neurocognitive deficits caused by PCI in patients who would never develop brain metastases. Methods and analysis This is a prospective multi-centre one-arm trial. A total of 80 patients diagnosed with LD-SCLC after confirmed response to standard of care radical chemoradiotherapy will be enrolled. Patients will be followed-up by brain MRI every 3 months up to 3 years. Neurocognitive function tests will be performed at baseline and after 12 and 24 months. Patients who develop brain metastases during observation will be irradiated. In case of limited number and volume of metastases SRT will be offered to patients; others will be treated with WBRT. The primary endpoint of the trial is overall survival. We have assumed that our approach will not compromise overall survival of treated patients. 2-year survival will be at least 50% in our trial compared to 36% for a group of 138 patients LD-SCLC from our institution treated in 2003-2006 with radical chemoradiotherapy and PCI. The secondary endpoints were designed to asses the risk of developing brain metastases without PCI; to assess the efficacy of radiotherapy of early detected brain metastases, including the feasibility and efficacy of SRT; to assess neurocognitive functions and QoL in the studied cohort. QLQ-C30 questionnaire and the California Verbal Learning Test (CVLT), Color connection test (CTT), Benton visual memory test (BNRT) and Verbal fluency test (VFT) will be carried out by the certified psychologist. Ethics and dissemination The trial received ethical approval from the local medical university Bioethical Review Board (Komisja Bioetyczna Collegium Medicum Uniwersytet Warmińsko-Mazurski w Olsztynie). The results of the trial will be disseminated through peer-reviewed publications and conference presentations.

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  24 months

Study Arms (1)

PCI- free after response to radical chemoradiotherapy

EXPERIMENTAL

Patients with no metastases will be followed-up with MRI: at the qualifying visit before MRI-1, and then every 6 months +/- 2 weeks), the patients will have a cognitive examination performed using dedicated neuropsychological tests and QoL assessment using the QLQ-C30 questionnaire. The tests will be conducted in the following order: California verbal learning test (CVLT) with a delay of 15 min, Color connection test (CTT), CVLT (after delay), Benton visual memory test (BNRT), Verbal fluency test by the certified psychologist.

Diagnostic Test: Magnetic resonance imaging (MRI)

Interventions

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

instead of PCI patients will be followed-up with MRI

PCI- free after response to radical chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

• confirmed histologically small cell lung cancer, confirmed by staging limited disease SCLC, complete or good response to local chemoradiotherapy, good performance status (ECOG/WHO=0-2), signed informed consent

You may not qualify if:

• disseminated disease (ED-SCLC), contraindication to MRI, not able to perform cognitive function tests, poor PS (ECOG/WHO \>2)

Sponsors & Collaborators

• Sergiusz Nawrocki: lead

Study Sites (1)

Katedra Onkologii, Wydział Lekarski, Collegium Medicum, Uniwersytet Warmińsko-Mazurski

Olsztyn, Warmia I Mazury, 10-228, Poland

RECRUITING

Related Publications (1)

• Nawrocki S, Sugajska A. Study protocol: watchful observation of patients with limited small cell lung cancer instead of the PCI-prospective, multi-center one-arm study. BMC Cancer. 2020 Mar 18;20(1):231. doi: 10.1186/s12885-020-06721-8.

  PMID: 32188425 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Sergiusz Nawrocki, MD, PhD

CONTACT

+48 895398310; sergiusz.nawrocki@uwm.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Oncology Dept.

Model Details: deescalation of treatment - watchful observation instead of Whole Brain Irradiation

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 19, 2019
• Study Start: September 2, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)