Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

First, surgery resection of the affected lung with mediastinal lymph node dissection, including sub- and para-aortic lymph node, will be performed. If malignant tumor involvement only in the sub- or para-aortic lymph nodes is identified, adjuvant chemotherapy will be initiated within 8 weeks after surgery. After completion of adjuvant chemotherapy, post-operative radiotherapy will be initiated within 2\~4 weeks after adjuvant chemotherapy.

Primary surgical resection with sequential adjuvant therapy

Jung Seop Eom, Master

The purpose of this study is to identify the treatment outcomes of surgical resection with sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell lung cancer and N2 disease at only the sub- or para-aortic level.

Stage IIIA non-small cell lung cancer (NSCLC) is a very heterogeneous disease and current treatment guidelines recommend concurrent chemoradiation therapy or combined neoadjuvant chemotherapy, surgical resection, and sequential adjuvant therapy. When incidental N2 disease is found despite thorough preoperative staging, adjuvant platinum-based chemotherapy with or without adjuvant radiotherapy is recommended.

Although guidelines suggest preoperative mediastinal staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), this method does not allow approach of the sub- or para-aortic lymph nodes. Therefore, patients with suspected stage IIIA NSCLC and N2 disease only at the sub- or para-aortic level should undergo several processes if combined neoadjuvant chemotherapy and surgical resection is planned. First, video-assisted thoracoscopic surgery (VATS) should be performed to verify whether the sub- or para-aortic lymph nodes are involved. If a frozen-section biopsy reveals no malignant tumor involvement in the sub- and para-aortic lymph nodes, the affected lung can be resected. If there is sub- or para-aortic lymph node involvement, further neoadjuvant chemotherapy is required before surgical resection and adjuvant therapy.

Studies have shown that stage IIIA NSCLC with only sub- or para-aortic lymph node involvement has better outcomes than other stage IIIA NSCLC. Moreover, the five-year survival of patients with stage IIIA NSCLC with only sub- or para-aortic lymph node involvement is similar to that with stage II NSCLC. However, those studies were retrospective with relatively small sample sizes. Therefore, we evaluated the outcomes of combined surgical resection with adjuvant chemotherapy and radiotherapy in patients with stage IIIA NSCLC and N2 disease at only the sub- or para-aortic level.

Strategy of Surgical Resection With Adjuvant Therapy for IIIA NSCLC and N2 Disease Only in Subaortic or Paraaortic Level

Treatment Strategy of Surgical Resection With Sequential Adjuvant Chemotherapy and Radiotherapy for Patients With Stage IIIA Non-small Cell Lung Cancer and N2 Disease Only in the Subaortic or Paraaortic Level, or Both

Pusan National University Hospital

Clinical assistant professor

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Stomach Neoplasms

Lymphatic Metastasis

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Oxaliplatin

Antimetabolites

Research subjects who were enrolled in CLASSIC trial and underwent adjuvant chemotherapy.

Research subjects who were enrolled in CLASSIC trial and did not undergo adjuvant chemotherapy

Capecitabine, oxaliplatin

The pattern of lymph node metastasis of the gastric cancer to each geographic lymph nose stations and the relation between each metastasis and survival are to be analyzed by retrospective review of medical records of who enrolled in the CLASSIC trial (NCT00411229) which have compared adjuvant chemotherapy and no adjuvant therapy after radical gastrectomy with extended lymphadenectomy.

Lymph Node Metastasis in Extended Lymphadenectomy for Gastric Cancer From a CLASSIC Trial

Pattern and Clinical Implication of Lymph Node Metastasis From Gastric Cancer Which Was Resected by Radical Surgery With Extended Lymphadenectomy

Saint Vincent's Hospital, Korea

Gachon University Gil Medical Center

Gangnam Severance Hospital

Kyungpook National University Hospital

Kyunghee University Medical Center

Keimyung University Dongsan Medical Center

Korea University Guro Hospital

Korea University Anam Hospital

Kosin University Gospel Hospital

National Cancer Center, Korea

Seoul Veterans Hospital

Seoul National University Bundang Hospital

Soonchunhyang University Hospital

Severance Hospital

Ajou University

Yeungnam University Hospital

Korea Cancer Center Hospital

Ewha Womans University Mokdong Hospital

Chonbuk National University Hospital

Chonnam National University Hospital

Seoul National University Hospital

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Micronutrients

Hematinics

Pharmaceutical Solutions

Iron

Ferrosoferric Oxide

Parenteral Nutrition Solutions

Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.

6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.

Feraheme

MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.

Magnetic Resonance Imaging (MRI)

Haesun Choi, MD

The goal of this clinical research study is to learn if the drug Feraheme ® (ferumoxytole) helps researchers most clearly to "see" cancerous lymph nodes on an MRI scan. Researchers also want to learn if ferumoxytole may be used in liver imaging.

Ferumoxytole is designed to deliver iron to treat iron-deficiency anemia (low red blood cell counts) in patients with chronic kidney disease. In this study, it will be used as an MRI contrast. Contrasts are used by doctors in order to see MRI images more clearly.

Study Participation:

If you are found to be eligible, during the following MRI scans, you will pass into a long, narrow tube scanner, which is open at both ends. You will have a total of 3 MRI scans.

You will have an MRI scan before you receive ferumoxytole as needed. This is the standard-of-care MRI scan. You will then receive ferumoxytole by vein. If you are scheduled to have an MRI scan of your abdomen, or if you have visible lymph nodes in the abdomen, you will stay in the MRI scanner an extra 30 minutes for liver imaging right after you receive your dose of ferumoxytole. This is a part of an investigational scan (Visit 1--Day 1)

You will then return for an MRI scan 2 days later (Visit 2--Day 2) and then again the following day (Visit 3--Day 3) to scan your lymph nodes. These are the investigational scans. The timing of the second and third scans may be changed based on the study doctor's decision.

Length of Study:

Your participation on this study will be over after the third MRI scan.

Additional Information:

The images collected as part of this study will not be included as part of your medical record. If any of the images and/or information from this study are used for publication, all identifiable information will be removed. The data will be stored for 5 years after the study data has been published.

This is an investigational study. Ferumoxytole is FDA approved and commercially available for the treatment of iron-deficiency anemia in patients with chronic kidney disease. Its use to help researchers "see" cancerous lymph nodes from an MRI scan is considered investigational.

Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging

Signal intensity (SI) change of a lymph node between the pre- and post- contrast images observed subjectively at each time point. The degree of SI change at each time point compared each other subjectively and a time point showing the nodes best (greatest signal loss relative to that on pre-contrast images) identified (optimum scan time).

M.D. Anderson Cancer Center

Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.

Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.

Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Haesun Choi, MD/ Professor, Abdominal Imaging Department

Number of Participants With Signal Intensity (SI) Change of a Lymph Node Between the Pre- and Post- Contrast of the Feraheme Enhanced Magnetic Resonance Imaging (MRI)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Strategy of Surgical Resection With Adjuvant Therapy for IIIA NSCLC and N2 Disease Only in Subaortic or Paraaortic Level	NCT02555592	Lung Cancer Cancer of Lymph... Effects of Chem... Surgery	Primary surgica...	18 Years -	Pusan National University Hospital
Strategy of Surgical Resection With Adjuvant Therapy for IIIA NSCLC and N2 Disease Only in Subaortic or Paraaortic Level	NCT02555592	Lung Cancer Cancer of Lymph... Effects of Chem... Surgery	Primary surgica...	18 Years -	Pusan National University Hospital
Lymph Node Metastasis in Extended Lymphadenectomy for Gastric Cancer From a CLASSIC Trial	NCT02298010	Stomach Neoplas... Cancer of Lymph...	Capecitabine, o...	18 Years -	Seoul National University Hospital
Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging	NCT01815333	Cancer of Lymph...	Feraheme Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center

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