STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER Clinical Trial
Official title:
A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)
| Verified date | October 2021 |
| Source | University of Texas Southwestern Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.
| Status | Completed |
| Enrollment | 98 |
| Est. completion date | June 3, 2019 |
| Est. primary completion date | June 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable. - Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume. - Patients with Zubrod performance status 0-1 - Adequate hematologic function - FEV1 with = 1200 cc or = 50% predicted Exclusion Criteria: - Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer - Exudative, bloody, or cytologically malignant effusions - Prior therapy with any molecular targeted drugs (for lung cancer) - Active pulmonary infection not responsive to conventional antibiotics - Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. - Patients with > grade 1 neuropathy |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
| United States | UPMC Cancer Center | Pittsburgh | Pennsylvania |
| United States | University of Rochester | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University of Texas Southwestern Medical Center | Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 2-year Overall Survival (Phase II) | 2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years. | 2 years | |
| Secondary | The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy | The feasibility as measured by the number of participants who had grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment; compliance us defined as the completion of the treatment regimen with no more than minor variations. | 60 days of the start of treatment | |
| Secondary | Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy | The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria | 1,6,12,18,24 month | |
| Secondary | Proportion of Participants With Progression-free Survival (Phase II) | Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method. | 2 years | |
| Secondary | Median Overall Survival (Phase II) | Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. | every 6 months up to 24 months (approx. 22 months) | |
| Secondary | EuroQol-5Dimension (EQ-5D) MUS Score at Baseline | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.
Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." |
Baseline | |
| Secondary | EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.
Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." |
End of treatment (6 weeks) | |
| Secondary | EuroQol-5Dimension (EQ-5D) VAS Score at Baseline | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.
Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. |
Baseline | |
| Secondary | EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.
Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. |
End of Treatment (6 weeks) | |
| Secondary | EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale.
Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. |
24 month follow up | |
| Secondary | EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems.
Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." |
24 month follow up |