- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619448
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung cancer is the leading cause of cancer related deaths for both men and women in the United States. In 2014 the estimated number of new lung cancer cases in the United States is 224,210. Approximately 159,260 people are estimated to die from lung cancer in 2014. Non-small cell lung cancer (NSCLC) constitutes 80% of all lung cancer cases. The standard treatment for patients with NSCLC and clinically negative lymph nodes remains surgery per NCCN guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgical resection with lobectomy. A significant number of these patients have cardio-pulmonary or other co-morbidities which preclude them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their co-morbidities. This forms the rationale for treating medically inoperable early stage lung cancer patients with definitive therapy.
Treatment with radiotherapy (RT) has been the standard option for patients unable to undergo surgery. Radiation alone leads to slightly better outcomes but still not equivalent to surgery with 60-70% local failure with conventional fractionated radiotherapy over several weeks. The development of three-dimensional conformal radiotherapy (3DCRT) has allowed for more focused treatment while avoiding nearby normal tissue resulting in improved disease specific survival but overall survival is still poor.
There is currently no data supporting the use of chemotherapy in the medically inoperable group either in an adjuvant setting or concurrently with RT in those with early stage lung cancer. In patients with unresectable Stage IIIA and IIIB NSCLC, combined chemo-RT has been proven to be superior to RT alone. Two randomized studies that compared concurrent versus sequential chemo-radiotherapy found that the concurrent approach provides superior outcomes. However this approach has not been studied in early stage lung cancer in the medically inoperable group. The medically inoperable patient cohort often does not undergo surgical staging, which increases the odds that they harbor occult regional disease. Chemotherapy given concurrently with radiation will act as a radiosensitizer and improve local disease control and could decrease rate of distant metastases. It is possible that the medically inoperable population also experience more side effects due to their co-morbidities and poor performance status. Hence there is a need to determine if concurrent chemoradiation is feasible and tolerable in the medically inoperable patients. The main side effect associated with concurrent chemoradiation in stage III NSCLC is esophagitis. This arises due to effect of radiation therapy to the regional lymph node (LN). The investigators' study population with early stage lung cancer has no nodal involvement. Hence, the investigators do not anticipate esophagitis being a major side effect in the researchers' study.
There is recent data for adjuvant chemotherapy in the medically operable group. Data from the Lung Adjuvant Cisplatin Evaluation (LACE) showed with a median follow-up time of 5.2 years, the overall HR of death was 0.89 (95% CI, 0.82 to 0.96; P = .005), corresponding to a 5-year absolute benefit of 5.4% from chemotherapy. A similar trial evaluating the role of sequential chemotherapy after stereotactic body radiation therapy (SBRT) in the medically inoperable population was attempted at the investigators' institution but was closed due to poor accrual. Hence, the investigators are looking at the role of concurrent chemo-RT in this population.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Erin Bingham, BS
- Phone Number: 3154643603
- Email: binghame@upstate.edu
Study Contact Backup
- Name: Sherice Simpson, MS
- Phone Number: 3154645934
- Email: simpsons@upstate.edu
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Recruiting
- SUNY Upstate Medical University
-
Contact:
- Erin Bingham, BS
- Phone Number: 315-464-3603
- Email: binghamE@upstate.edu
-
Contact:
- Sherice Simpson, MS
- Phone Number: 315-464-5934
- Email: simpsons@upstate.edu
-
Principal Investigator:
- Michael Mix, MD
-
Sub-Investigator:
- Jeffrey Bogart, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion 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:
- Surgical resection is allowed if surgery was > 12 months ago.
- 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.
- Prior chemotherapy if > 18 months ago
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy with hypofractionated RT
Carboplatin AUC 2 + Paclitaxel 50 mg/m2 given weekly x 4 concurrently with radiation therapy (70 Gy in 20 fractions) over 4 weeks
|
chemotherapy
Other Names:
chemotherapy
Other Names:
accelerated hypofractionated RT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity as measured using the National Cancer Institute's Common Terminology Criteria for Adverse Events
Time Frame: 24 months
|
Specifically grade 3+ toxicity associated with the treatment will be summarized by grade and type.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiographic response as measured by PET/CT
Time Frame: 24 months
|
24 months
|
Local progression as measured by PET/CT
Time Frame: 24 months
|
24 months
|
Regional progression as measured by PET/CT
Time Frame: 24 months
|
24 months
|
Distant progression as measured by PET/CT
Time Frame: 24 months
|
24 months
|
Time to overall progressions as measured by PET/CT
Time Frame: 24 months
|
24 months
|
Overall survival as determined by patient contact
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Mix, MD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 665895
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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