RECRUITING

Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC

Conditions

Non-small Cell Lung Cancer inoperable Solitary [T1bN0, T2aN0, T2bN0] lesion measuring 2-7 cm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically negative lymph nodes remains surgery per current guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of these patients have heart and lung issues or other diseases which keep them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their other diseases. This is the reason for treating early stage lung cancer patients with definitive therapy, when they cannot have surgery. This study will enroll twelve subjects to evaluate the side effects of this treatment, and decide if it is a good option for the patients that cannot have surgery.

Official Title

Pilot Study of the Safety and Feasibility of Administering Concurrent Chemotherapy and Accelerated Hypofractionated Radiation Therapy in the Treatment of Medically Inoperable T2A-T4 N0 Non-small Cell Lung Cancer.

Quick Facts

Study Start:2014-12

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02619448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Pathologically or cytologically proven diagnosis of non-small cell lung carcinoma. * Solitary \[T1bN0M0, T2aN0M0, T2bN0M0\] lesion measuring 2-7cm in size. Staging is per AJCC 7th edition of TNM classification. * Patient must meet criteria for receipt of hypofractionated radiation therapy * Medically inoperable pulmonary status, cardiac status, or other serious co-morbidity, or patient refusal of primary surgery for lung cancer. * ECOG Performance status of 0-2. * Patients may have prior treatment for lung cancer based on the following criteria: 1. Surgical resection is allowed if surgery was \> 12 months ago. 2. Patients treated with prior radiation are eligible if radiation was \> 12 months ago and there is no evidence of progression and if the lesion is in a different lobe. 3. Prior chemotherapy if \> 18 months ago	* Node positive or metastatic disease. * Other active malignancy (specifically, risk of recurrence in 3 years estimated to be greater than 50%) except for non-melanoma skin cancer, in-situ cervical carcinoma (CIN), or low-risk prostate carcinoma on active surveillance are to be excluded. * Inability to receive systemic therapy or radiation therapy per protocol. * Inability to fulfill requirements of the protocol. * Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.

Inclusion Criteria

Exclusion Criteria

* Pathologically or cytologically proven diagnosis of non-small cell lung carcinoma.
* Solitary \[T1bN0M0, T2aN0M0, T2bN0M0\] lesion measuring 2-7cm in size. Staging is per AJCC 7th edition of TNM classification.
* Patient must meet criteria for receipt of hypofractionated radiation therapy
* Medically inoperable pulmonary status, cardiac status, or other serious co-morbidity, or patient refusal of primary surgery for lung cancer.
* ECOG Performance status of 0-2.
* Patients may have prior treatment for lung cancer based on the following criteria:
1. Surgical resection is allowed if surgery was \> 12 months ago.
2. Patients treated with prior radiation are eligible if radiation was \> 12 months ago and there is no evidence of progression and if the lesion is in a different lobe.
3. Prior chemotherapy if \> 18 months ago

* Node positive or metastatic disease.
* Other active malignancy (specifically, risk of recurrence in 3 years estimated to be greater than 50%) except for non-melanoma skin cancer, in-situ cervical carcinoma (CIN), or low-risk prostate carcinoma on active surveillance are to be excluded.
* Inability to receive systemic therapy or radiation therapy per protocol.
* Inability to fulfill requirements of the protocol.
* Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.

Contacts and Locations

Study Contact

Erin Bingham, BS

CONTACT

3154643603

binghame@upstate.edu

Sherice Simpson, MS

CONTACT

3154645934

simpsons@upstate.edu

Principal Investigator

Michael Mix, MD

PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Study Locations (Sites)

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

Collaborators and Investigators

Sponsor: State University of New York - Upstate Medical University

Michael Mix, MD, PRINCIPAL_INVESTIGATOR, State University of New York - Upstate Medical University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-12

Study Completion Date2025-12

Study Record Updates

Study Start Date2014-12

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

inoperable
Solitary [T1bN0, T2aN0, T2bN0] lesion measuring 2-7 cm

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer