HS-PCI in Locally Advanced Adenocarcinoma of the Lung

NCT02341170 | Withdrawn

• 1 other identifier: HIPPO-S
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of this study is evaluate the impact of hippocampal-sparing prophylactic cranial irradiation (HS-PCI) on survival status in patients with nodal-positive (locally advanced) adenocarcinoma by comparing overall survival rates of patients undergoing HS-PCI to that of patients without this intervention. In addition, this study aims to investigate whether HS-PCI is detrimental on neurocognitive function and to evaluate its impact on the patient's quality of life.

Conditions

Lung Cancer; Adenocarcinoma; Lymphatic Metastasis

Outcome Measures

Primary Outcomes (1)

• 1-year overall survival rate

  1 year

Secondary Outcomes (8)

• Overall survival (OS)

  1 year

• Progression-free survival (PFS)

  1 year

• Incidence of brain metastasis

  1 year

• Incidence of brain metastases within the hippocampal avoidance volume

  1 year

• Adverse events

  1 year

Study Arms (2)

HS-PCI

EXPERIMENTAL

Hippocampal-sparing prophylactic cranial irradiation (25 Gy in 10 fractions)

Radiation: HS-PCI

Observation

NO INTERVENTION

Observation

Interventions

HS-PCI RADIATION

Hippocampal-sparing prophylactic cranial irradiation with 25 Gy in 10 fractions

HS-PCI

Eligibility Criteria

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

You may qualify if:

• Cytologically or histologically confirmed adenocarcinoma of the lung
• Clinical Stage III with lymph node stage N1-N3
• Stable disease or any response after definitive or adjuvant radio(chemo)therapy (defined by local standards)
• No more than 8 weeks after completion of prior radio(chemo)therapy
• Any acute/subacute ≥ grade 3 toxicities from previous therapy must have resolved to ≤ grade 2 at the time of study entry
• Age ≥ 18 years and \< 75 years
• ECOG Performance Status ≤ 1
• Signed study-specific informed consent prior to study entry.

You may not qualify if:

• Stage III with T4 N0
• Evidence of progressive disease at the time of study entry
• Brain or leptomeningeal metastases (cMRI not older than 2 weeks)
• Evidence of extracranial distant metastatic disease
• Prior cranial irradiation
• Patients enrolled in other clinical studies that apply or test lung cancer-directed investigational agents/procedures
• Patients with synchronous or prior malignancy, other than non-melanomatous skin cancer unless disease free greater than 3 years
• Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception.
• Patients that are unable to undergo repetitive MRI scans
• Medical conditions that contra-indicate intensive neurocognitive testing (e.g., history of mental retardation, aphasia of any kind, hearing impairment)

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Related Publications (5)

• Gondi V, Pugh SL, Tome WA, Caine C, Corn B, Kanner A, Rowley H, Kundapur V, DeNittis A, Greenspoon JN, Konski AA, Bauman GS, Shah S, Shi W, Wendland M, Kachnic L, Mehta MP. Preservation of memory with conformal avoidance of the hippocampal neural stem-cell compartment during whole-brain radiotherapy for brain metastases (RTOG 0933): a phase II multi-institutional trial. J Clin Oncol. 2014 Dec 1;32(34):3810-6. doi: 10.1200/JCO.2014.57.2909. Epub 2014 Oct 27.

  PMID: 25349290 BACKGROUND

• Ghia A, Tome WA, Thomas S, Cannon G, Khuntia D, Kuo JS, Mehta MP. Distribution of brain metastases in relation to the hippocampus: implications for neurocognitive functional preservation. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):971-7. doi: 10.1016/j.ijrobp.2007.02.016. Epub 2007 Apr 18.

  PMID: 17446005 BACKGROUND

• Harth S, Abo-Madyan Y, Zheng L, Siebenlist K, Herskind C, Wenz F, Giordano FA. Estimation of intracranial failure risk following hippocampal-sparing whole brain radiotherapy. Radiother Oncol. 2013 Oct;109(1):152-8. doi: 10.1016/j.radonc.2013.09.009. Epub 2013 Oct 4.

  PMID: 24100152 BACKGROUND

• Gore EM, Bae K, Wong SJ, Sun A, Bonner JA, Schild SE, Gaspar LE, Bogart JA, Werner-Wasik M, Choy H. Phase III comparison of prophylactic cranial irradiation versus observation in patients with locally advanced non-small-cell lung cancer: primary analysis of radiation therapy oncology group study RTOG 0214. J Clin Oncol. 2011 Jan 20;29(3):272-8. doi: 10.1200/JCO.2010.29.1609. Epub 2010 Dec 6.

  PMID: 21135270 BACKGROUND

• Giordano FA, Welzel G, Abo-Madyan Y, Wenz F. Potential toxicities of prophylactic cranial irradiation. Transl Lung Cancer Res. 2012 Dec;1(4):254-62. doi: 10.3978/j.issn.2218-6751.2012.10.03.

  PMID: 25806190 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederik Wenz, MD

  Department of Radiation Oncology, University Medical Centre Mannheim

  STUDY CHAIR

• Frank A. Giordano, MD

  Department of Radiation Oncology, University Medical Centre Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 19, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04