Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
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Purpose
Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from Phase I/II studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.
Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.
We propose to conduct a study to determine how well water soluble iodinated contrast material when injected directly into the tumor can be visualized on CT scan and integrated into radiation therapy treatment planning.
| Condition | Intervention |
|---|---|
|
Lung Cancer Lung Cancer Non-Small Cell Cancer (NSCLC) Lung Cancer Small Cell Lung Cancer (SCLC) Mesothelioma |
Procedure: Stereotactic Body Radiation Therapy (SBRT) Drug: Iohexol Radiation: Computed Tomography (CT) Device: Cyberknife Device: Trilogy Device: True Beam |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Pulmonary Interstitial Lymphography in Early Stage Lung Cancer |
- - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- - Feasibility of incorporating primary nodal drainage into radiation therapy planning process [ Time Frame: 15 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
|
Procedure: Stereotactic Body Radiation Therapy (SBRT)
standard of care
Drug: Iohexol
1 to 5 cc
Radiation: Computed Tomography (CT)
For each patient, Chest CT scans will be obtained: 1 before and 2 after interstitial injection of water soluble contrast
Device: Cyberknife
Linear accelerator for producing high energy x-rays for radiation therapy.
Device: Trilogy
Linear accelerator for producing high energy x-rays for radiation therapy.
Device: True Beam
Linear accelerator for producing high energy x-rays for radiation therapy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Either 1. Established primary lung cancer/ cancer metastatic to lung, OR 2. Lesion suspicious for malignancy in lung, according to the following criteria:
A. Histopathologically confirmed lung cancer or cancer metastatic to lung, OR B. Plan for biopsy of suspicious lung mass based on imaging (growth on serial CT scan or nodule/mass with focal hypermetabolism on FDG-PET scan), OR C. Known metastatic cancer, with metastases to the lung based on imaging
- Age > 18 years old
- Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix IV)
- No prior surgery, chemotherapy, or radiation for the current lung tumor
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:- Prior radiotherapy to thorax
- Allergy to iodine
- Contraindication to receiving radiotherapy, unless undergoing surgery
- Women who are pregnant
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Dr. Billy W. Loo Jr. M.D. Ph.D. | Stanford University |
| Principal Investigator: | Jonathan Abelson | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01188486 History of Changes |
| Other Study ID Numbers: | LUN0040, 18395 |
| Study First Received: | August 23, 2010 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Non-Small-Cell Lung Mesothelioma Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial |
ClinicalTrials.gov processed this record on May 19, 2013