Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/1/2018 |
| Start Date: | July 2014 |
| End Date: | September 2017 |
Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients With Stage II-III Non-small Cell Lung Cancer
This study will help researchers test the safety of hypofractionated dose of radiotherapy
(HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung
Cancer.
(HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung
Cancer.
Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This
protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per
cohort.
Patients will be offered the opportunity to participate in the blood specimen component of
the study.
Patients will be followed up to 2 years post radiation therapy.
Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation
therapy. Patients have the option of consolidative chemotherapy at week 12.
Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst
during week 7. Patients have the option of consolidative chemotherapy at week 12.
HySBst dose escalation for each sub-group is listed below:
Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4
daily fractions Level 3: 6 Gy x 4 daily fractions
DLTs will be based on events occurring during the course of HySBst.
Chemo-Radiation Therapy is defined as:
Standard Carboplatin & Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and
Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT
Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks
Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21
days x 2 cycles will be given after ALL radiotherapy is delivered.
protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per
cohort.
Patients will be offered the opportunity to participate in the blood specimen component of
the study.
Patients will be followed up to 2 years post radiation therapy.
Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation
therapy. Patients have the option of consolidative chemotherapy at week 12.
Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst
during week 7. Patients have the option of consolidative chemotherapy at week 12.
HySBst dose escalation for each sub-group is listed below:
Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4
daily fractions Level 3: 6 Gy x 4 daily fractions
DLTs will be based on events occurring during the course of HySBst.
Chemo-Radiation Therapy is defined as:
Standard Carboplatin & Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and
Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT
Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks
Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21
days x 2 cycles will be given after ALL radiotherapy is delivered.
Inclusion Criteria:
- Stage II - III Non Small Cell Lung Cancer
Exclusion Criteria:
- Primary tumor directly invading into any mediastinal structures, such as the heart,
major blood vessels, esophagus, trachea, and the proximal bronchial tree.
- Prior chemotherapy for NSCLC
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields.
- Severe, active co-morbidity
- Pregnancy or women of childbearing potential
- Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin
- Uncontrolled neuropathy ≥ grade 2.
We found this trial at
1
site
Click here to add this to my saved trials
