Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer (HySBst)

West Virginia University

Status and phase: Terminated; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Radiation: Image-guided IMRT; Drug: Paclitaxel; Radiation: Hypofractionated Stereotactic Boost

Study type: Interventional

Funder types: Other

Identifiers

NCT02252796

WVU020513

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Sub-group 1

Experimental group

Description:

HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7

Treatment:

Radiation: Hypofractionated Stereotactic Boost

Radiation: Image-guided IMRT

Drug: Carboplatin

Drug: Paclitaxel

Sub-group 2

Experimental group

Description:

Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7

Treatment:

Radiation: Hypofractionated Stereotactic Boost

Radiation: Image-guided IMRT

Drug: Carboplatin

Drug: Paclitaxel