Early Hippocampal Avoidance Prophylactic Cranial Irradiation in Patients With LD SCLC

NCT02058056 | Completed

• 1 other identifier: SAKK 15/12
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

Brief Summary

The main objective of this trial is to assess NCF after early HA-PCI concomitant to the second cycle of CHT and to tRT for patients with LD SCLC.

Conditions

Small-Cell Lung Cancer

Keywords

Early prophylactic; cranial irradiation; hippocampal avoidance; limited disease small-cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Neurocognitive functioning (NCF)

  NCF at 6 months after end of HA-PCI treatment measured by Hopkins Verbal Learning Test Revised (HVLT-R), Controlled Oral Word Association (COWAT) and Trail Making Test Part A and B (TMT A/B). A neurocognitive decline is defined as a decrease of one standard error of measurement (SEM) in any of the four NCF tests.

  at 6 months

Secondary Outcomes (6)

• Brain metastasis free survival (BMFS)

  At 6 months and 12 months.

• Adverse events according to NCI CTCAE version 4.0

  Until 1 year after the end of HA-PCI treatment.

• Neurotoxicity

  Until 1 year after HA-PCI treatment.

• Individual tests for each cognitive domain (memory, verbal fluency, visual motor speed, executive function).

  At 6 weeks, 6 and 12 months after the end of HA-PCI treatment.

• Overall survival (OS)

  From time of registration (expected average of 20 months)

Study Arms (1)

Experimental: HA-PCI treatment

EXPERIMENTAL

Irradiation HA-PCI concomitant to the second cycle of CHT and to tRT for patients with LD SCLC

Radiation: Irradiation: HA-PCI

Interventions

Irradiation: HA-PCI RADIATION

25 Gy in 10 daily factions, five times a week

Experimental: HA-PCI treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed cytologically or histologically confirmed diagnosis of SCLC within 6 weeks before registration.
• Proven LD SCLC (CT thorax, abdomen, and bone scan (or PET/CT only) and brain MRI within 6 weeks before registration) according to the TNM classification version 7 that can be encompassed within a radical radiation port
• Only patients assessed by an interdisciplinary tumor board should be declared eligible taking into account eligibility for curative tRT and CHT according to NCCN Guidelines version 2.2014
• Karnofsky Index ≥ 60%
• Age at registration 18 to 75 years
• Normal bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
• Calculated creatinine clearance ≥ 60 mL/min is required if chemotherapy with cisplatin is scheduled. If cisplatin has to be replaced by carboplatin a creatinine clearance ≥ 50 mL/min is required
• Normal liver function: bilirubin ≤ 1 x ULN, AST and ALT ≤1.5 x ULN
• Fluency in either German, French or Italian
• Baseline QoL questionnaires FACT-Br and GHQ-12 have been completed within 14 days before registration
• Baseline NCF assessments have been completed within 14 days before registration:
• HVLT-R
• COWAT
• TMT A
• TMT B

You may not qualify if:

• Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
• History of CNS metastases
• Prior brain RT
• History of RT to the thorax
• Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms, participating in assessing NCF testing or interfering with compliance for oral drug intake.
• Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry.
• Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
• Any concomitant drugs contraindicated for use with the treatment drugs according to the approved product information.
• History of cerebrovascular disease or epilepsy requiring continuous treatment
• Symptomatic cardiac disease or a history of myocardial infarction within the previous 3 months
• Any psychological, familial or sociological/geographical conditions potentially hampering compliance with the study protocol and follow-up schedule
• Legal incapacity or limited legal capacity

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (8)

Universitätsspital Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Hopital Fribourgeois

Fribourg, 1708, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesca Caparrotti, MD

  Hôpitaux Universitaires de Genève, Genève

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 7, 2014
• Study Start: July 11, 2014
• Primary Completion: June 7, 2018
• Study Completion: December 3, 2018
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (8)