Clinical trial NCT02252796: Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Radiotherapy Therapy
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose of HySBst
timeFrame: 2 years
Secondary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 1 week
measure: Blood Sample Collection
timeFrame: 2 years
measure: Local Control
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: West Virginia University - Mary Babb Randolph Cancer Center
name: Malcolm Mattes, MD
role: PRINCIPAL_INVESTIGATOR
References: