A Phase 2 interventional study of Carboplatin and Paclitaxel in Carcinoma, Non Small Cell Lung (NSCLC), sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
This is a prospective phase II study designed to evaluate an accelerated and adaptive RT approach for locally-advanced non-small cell lung cancer (NSCLC). All eligible subjects will have an interim PET-CT during radiation therapy to determine the metabolic complete response rate. Radiation therapy will be given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Interim responses will be assessed using PERCIST criteria.
Despite concurrent chemotherapy and radiation therapy, local/regional failure occurs in \~50% of patients with locally-advanced NSCLC. Clinical studies have demonstrated that accelerated fractionation (giving the same total dose in a shorter period of time) improves outcomes in several malignancies, including lung cancer. Administering higher than conventional doses of RT to all sites of original disease leads to inferior outcomes. Adapting the RT approach, giving a higher dose to slowly responding disease as assessed with interim PET has been shown to be feasible. PERCIST (Positron Emission Tomography Response Criteria in Solid Tumors) provides guidelines on how to report responses to therapy based on PET-CT. PET-CT response has been shown to be prognostic in a variety of clinical scenarios in lung cancer including after induction therapy. In one study, PET was performed after neoadjuvant chemoradiotherapy (40-50.4 Gy). Complete or partial metabolic response using PERCIST criteria was predictive of loco-regional, distant, and overall progression-free survival.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 10 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pleural effusion: when pleural fluid is visible on both CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
Patients with effusions that are minimal (i.e. not visible on chest x-ray) or that are too small to safely tap are eligible
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
Drug: Carboplatin · Drug: Paclitaxel · Radiation: Daily hyperfractionated radiation therapy
Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
All subjects will receive 6 fractions(2Gy per fraction) of radiation therapy weekly. All subjects will complete an interim PET-CT after 48Gy-54Gy of RT . Subjects with a complete response on PET will complete RT at 60 Gy; subjects who have residual disease on interim PET and meet strict planning constraints eligibility will proceed to boost RT for a total RT dose of 72Gy. Interim PET-CT response will be measured using PERCIST criteria.
The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy
For the cohort of the participants who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.
Time frame: 4 weeks
The Number of Participants Eligible for an RT Boost After Completing a Standard Dose of RT (60 Gy), Delivered in an Accelerated Fashion (6 Fractions/Week) With Concurrent Chemotherapy
In the same participant cohort, the proportion of the participants who are eligible for an RT boost after completing a standard dose of RT (60 Gy), delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy, will be estimated as well as its confidence interval.
Time frame: 4 weeks
Overall Survival With an Accelerated and Adaptive RT Approach.
The overall survival (OS) for the treated participants will be characterized by Kaplan-Meier estimator. The medial OS will be estimated with a 95% confidence interval.
Time frame: 2 years
Progression-free Survival (PFS) With an Accelerated and Adaptive RT Approach.
Median progression-free survival for participants will be characterized by Kaplan-Meier estimator. The median PFS will be estimated as well as their 95% confidence intervals.
Time frame: 2 years
Number of Participants With Local Control With an Accelerated and Adaptive RT Approach
The local control rate for the same cohort of participants will be measured by standard of care imaging per NCCN guidelines at routine follow up clinic visits.
Time frame: 2 years
| Milestone | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Started | 10 |
| Completed | 1 |
| Not completed | 9 |
For the cohort of the participants who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.
| Participants | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Progressive Disease | 1 |
| Stable Disease | 6 |
| Partial Response | 1 |
| Complete Response | 0 |
In the same participant cohort, the proportion of the participants who are eligible for an RT boost after completing a standard dose of RT (60 Gy), delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy, will be estimated as well as its confidence interval.
| Participants | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| The Number of Participants Eligible for an RT Boost After Completing a Standard Dose of RT (60 Gy), Delivered in an Accelerated Fashion (6 Fractions/Week) With Concurrent Chemotherapy | 3 |
The overall survival (OS) for the treated participants will be characterized by Kaplan-Meier estimator. The medial OS will be estimated with a 95% confidence interval.
| months | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Overall Survival With an Accelerated and Adaptive RT Approach. | NA (NA to NA) |
Median progression-free survival for participants will be characterized by Kaplan-Meier estimator. The median PFS will be estimated as well as their 95% confidence intervals.
| months | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Progression-free Survival (PFS) With an Accelerated and Adaptive RT Approach. | 13.39 (2.58 to NA) |
The local control rate for the same cohort of participants will be measured by standard of care imaging per NCCN guidelines at routine follow up clinic visits.
| Participants | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Number of Participants With Local Control With an Accelerated and Adaptive RT Approach | 1 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboplatin/Paclitaxel With Radiation Therapy | 2/10 (20%) | 6/10 (60%) | 9/10 (90%) |
| Event | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Allergic reactionImmune system disorders | 2/10 |
| Esophageal UlcerGastrointestinal disorders | 1/10 |
| EsophagitisGastrointestinal disorders | 1/10 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/10 |
| Cardiac troponin T increasedInvestigations | 1/10 |
| Event | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| FatigueGeneral disorders | 9/10 |
| Lymphocyte count decreasedInvestigations | 8/10 |
| Weight lossInvestigations | 8/10 |
| esophagitisGastrointestinal disorders | 8/10 |
| White blood cell decreasedInvestigations | 7/10 |
| Dermatitis radiationInjury, poisoning and procedural complications | 7/10 |
| Neutrophil Count decreasedInvestigations | 6/10 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/10 |
| Gastrointestinal disorders - Other, specifyGastrointestinal disorders | 5/10 |
| NauseaGastrointestinal disorders | 5/10 |
| Age, Continuous(years) | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Mean | 67.5 ± 7.18 |
| Sex: Female, Male(Participants) | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Female | 8 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Carboplatin/Paclitaxel With Radiation Therapy |
|---|---|
| United States | 10 |
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Carcinoma, Non-Small-Cell Lung→
Duke University