- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059967
Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC
A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OUTLINE: This is a dose-escalation study of IGART.
Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
After completion of study treatment, patients are followed up periodically for 5 years.
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified.
- The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging.
- All detectable tumor must be encompassed by radiation therapy fields.
- 18-fluorodeoxyglucose PET is required for staging and treatment planning.
- Atelectasis, if present, must involve less than a complete lung.
Laboratory values:
- Neutrophils >1500/µL
- Platelets >100,000/µL
- Bilirubin < 1.5 mg/dL
- Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase [SGOT]) < 2x upper limit normal
- Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase [SGPT]) < 2x upper limit normal
- Serum creatinine < 2.0 mg/dL
- Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min
- Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec
- Plan of curative radiotherapy with or without concurrent chemotherapy.
- Karnofsky Performance Scale score of ≥ 70%.
- Age ≥ 18 years old.
- Measurable disease on the planning CT.
Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the PTV covered by the prescription dose, and the attending physician must have reviewed and approved the DVHs as follows:
- total lung V20 Gy ≤ 30%
- mean esophageal dose ≤ 34 Gy
- esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30%
- heart V40 Gy ≤ 50%
- maximum brachial plexus dose ≤ 66 Gy
- maximum spinal cord PRV dose ≤ 50 Gy
- maximum aorta dose ≤ 66 Gy
- maximum main bronchus dose ≤ 66 Gy
- maximum dose ≥ 66 Gy allowed in only one lobar bronchus.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Prior radiation therapy to the thorax.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years.
- Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome.
- Oxygen supplementation required during therapy.
- Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.
- Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus.
- Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.
- Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms.
- History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy.
- Pregnant or lactating women.
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: Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)
Patients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33.
Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
|
Given IV
Other Names:
Given IV
Other Names:
Undergo IGART
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity
Time Frame: 3 months
|
(using daily image-guidance, deformable image registration, adaptive replanning at defined time points, and dose intensification at normal tissue tolerance) of radiotherapy delivered concomitantly with standard chemotherapy.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0
Time Frame: Up to 90 days from radiation therapy start
|
Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
|
Up to 90 days from radiation therapy start
|
Incidence of late toxicity measured using the Radiation Therapy Oncology Group Late Radiation Morbidity Scoring
Time Frame: Up to 5 years
|
Toxicities associated with higher dose per fraction during the SIVAB phase of the protocol will be tabulated and analyzed with respect to treatment dose, respective normal tissue structure and dose-volume parameters.
|
Up to 5 years
|
Practicability of the approach
Time Frame: Up to 5 years
|
Variations in respiratory patterns, tumor and CTV positions, as well as tumor volumes will be assessed on the respective under-treatment imaging studies.
The feasibility of deformable image registration will be benchmarked against manual contours of targets and normal tissue.
The practicability of IGART will be measured by assessing the necessary time, IT and personnel resources needed to conduct the study.
|
Up to 5 years
|
Tumor response evaluated according to Response Evaluation Criteria in Solid Tumors v1.1
Time Frame: Up to 15 years
|
Up to 15 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elisabeth Weiss, MD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma of Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- MCC-13-09209
- HM20000101 (Other Identifier: IRB)
- MCC-20000101 (Other Identifier: VCU Massey Cancer Center)
- NCI-2014-00163 (Registry Identifier: NCI)
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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