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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Information provided by: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01416961 |
Purpose
This study is needed to assess the feasibility of integrating this therapy with current treatment regimens. If this study shows success a formal phase II test study to conduct feasibility will be the next step. The first dose level chosen for this study is 66Gy of radiation to the tumor between LET and standard photon therapy. This dose is the current standard of care for stage III . If this dose is found to be feasible then the dose of LET will escalate to the total dose of 74Gy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Radiation: Radiation Therapy Drug: Chemotherapy - Squamous Cell Histologies Drug: Chemotherapy - NSCLC other than squamous cell |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients |
| Enrollment: | 0 |
| Study Start Date: | August 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologic or cytologic diagnosis of ipsilateral mediastinal lymph node involvement, or Tumors greater than 7 cm or with chest wall invasion, or involvement of one of the following diaphragm, phrenic nerve, mediastinal pleura or parietal pericardium with hilar or mediastinal lymph node involvement.
More than one mediastinal lymph node enlarged on CT scan and the same lymph nodes positive on PET scans or Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan.
Evidence of tumor extension into the mediastinum and/or mediastinal structures either at the time of mediastinoscopy, bronchoscopy or on CT scans.
Histologic or cytologic diagnosis of N3 lymph node involvement; or Enlarged N3 lymph nodes on CT scan that are positive on PET scan as well. Patient must not have extension of lymph node involvement to cervical lymph nodes other than supraclavicular lymph nodes; or Right sided primary with left vocal cord paralysis; or Patients with a nodules in the same lung but no other areas of involvement. Patients with prior surgically resected stage I NSCLC who did not receive any adjuvant therapy, who now have stage IIIA or B NSCLC will be eligible.
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Shirish M. Gadgeel, M.D., Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01416961 History of Changes |
| Other Study ID Numbers: | 2011-005 |
| Study First Received: | August 10, 2011 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Squamous Cell Non-squamous cell |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |