NCT01797159

Brief Summary

The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

March 11, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 18, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

November 30, 2012

Results QC Date

June 3, 2020

Last Update Submit

September 22, 2021

Conditions

Small-cell Lung CancerSCLCSmall Cell Lung Cancer Limited Stage

Keywords

Prophylactic Cranial IrradiationPCIHippocampal-sparing irradiation

Outcome Measures

Primary Outcomes (1)

  • Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall

    The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome.

    Baseline, 6 months and 12 months post radiation treatment

Secondary Outcomes (10)

  • Compare Cognitive Function Following Sparing PCI to That of Standard PCI

    Baseline

  • Compare Cognitive Function Following Sparing PCI to That of Standard PCI

    6 months post radiation treatment

  • Compare Cognitive Function Following Sparing PCI to That of Standard PCI

    12 months post radiation treatment

  • Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30

    Baseline and 6 months post radiation treatment

  • Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30

    Baseline and 12 months post radiation treatment

  • +5 more secondary outcomes

Study Arms (1)

Hippocampal-sparing PCI

EXPERIMENTAL

Hippocampal-sparing PCI 25 Gy in 10 fractions

Radiation: Hippocampal-sparing Prophylactic Cranial Irradiation

Interventions

Hippocampal-sparing Prophylactic Cranial IrradiationRADIATION

Hippocampal-sparing Prophylactic Cranial Irradiation

Hippocampal-sparing PCI

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must have newly diagnosed and confirmed small-cell lung cancer (SCLC)
  • Patient must have a performance status of 1 or higher
  • Patients must not have received previous irradiation to the brain
  • Patients must have limited stage disease with complete response to chemotherapy and consolidative chest radiotherapy that was documented at least on standard chest x-rays within one month of study entry
  • Negative MRI or CT scan of the brain at least one month before protocol entry
  • Women of child-bearing potential must have a negative pregnancy test and also agree to use adequate contraceptives while on protocol
  • Patient must be able to understand and sign the informed consent document
  • Patient must be informed of the investigational aspect to this trial prior to singing the informed consent document

You may not qualify if:

  • Patients receiving prior external beam irradiation to the head or neck, including any form of stereotactic irradiation
  • Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion
  • Planned concurrent chemotherapy or antitumoral agent during PCI
  • Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Patients with minimal pleural effusion evident on chest X-ray; minimal pleural effusion visible on chest CT is allowed.
  • Patients with epilepsy requiring permanent oral medication
  • Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits.
  • Patients may not take Memantine. This is the only eligibility criterion that has been added to those of RTOG 0212, since some physicians might now prescribe Memantine. This medication would not have been given at the time of enrollment on RTOG 0212 and its administration could confound the results of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bayview Medical Center

Baltimore, Maryland, 21227, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Redmond KJ, Hales RK, Anderson-Keightly H, Zhou XC, Kummerlowe M, Sair HI, Duhon M, Kleinberg L, Rosner GL, Vannorsdall T. Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):603-611. doi: 10.1016/j.ijrobp.2017.03.009. Epub 2017 Mar 14.

    PMID: 28581401DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
The SKCCC at Johns Hopkins
Organization
The SKCCC at Johns Hopkins
kjansen3@jhmi.edu
4109556980

Study Officials

  • Kristin Redmond, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

November 30, 2012

First Posted

February 22, 2013

Study Start

March 11, 2013

Primary Completion

March 18, 2018

Study Completion

March 18, 2019

Last Updated

October 18, 2021

Results First Posted

October 19, 2020

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share data with PIs who are not included on the study team.

Locations

US(2)