STEREOtactic Radiation and Chemotherapy in Lung Cancer (STEREO)

NCT01300299 | Withdrawn DMC

• 1 other identifier: BCC-LUN-10-STEREO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will test the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC).

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

lung cancer; radiation; stereotactic

Outcome Measures

Primary Outcomes (1)

• To measure the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC)

  3 years after subject enrollment

Secondary Outcomes (4)

• Survival rate, specifically disease-free survival (DFS) and overall survival (OS), measured by follow-up visits and tests

  3 years after subject enrollment

• safety of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non-small cell lung cancer (NSCLC) measured by adverse events

  3 years after subject enrollment

• quality of life (QOL) measured by subject questionnaires

  3 years after subject enrollment

• Measurement of biological and clinical markers for toxicity, DFS, and OS

  3 years after subject enrollment

Study Arms (1)

All subjects

EXPERIMENTAL

Subjects will receive chemotherapy after stereotactic body radiation therapy.

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

12 Gray (Gy) x 4 fractions (48 Gy) will be delivered to peripherally located tumors (\> 2 cm in all directions around the proximal bronchial tree and centrally located tumors (within \<2 centimeters (cm) of proximal bronchial tree). Treatment should be given on consecutive days. There will be 4 or 5 treatments.

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Histologically diagnosed non-small cell lung cancer(NSCLC, cT1-T3 (\<= 5cm) (AJCC 7ed). The following histologies are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine, or non-small cell carcinoma not otherwise specified; bronchioloalveolar cell carcinoma is a subtype of NSCLC but will be excluded from this study because assessment of multifocal disease spread through the airways is difficult.
• Required CT of the chest and abdomen with contrast unless medically contraindicated (evaluating both lungs, mediastinum, liver, and adrenals) and Whole Body Positron Emission Tomography (PET) for staging. An integrated PET/Computed Tomography (CT) will meet the CT and PET requirements for staging. Images must be read by a trained radiologist and performed 8 weeks prior to initiation of treatment. PET imaging must allow adequate visualization of the primary tumor, draining lymphatics in hilar and mediastinum, adrenals, and skeleton.
• Deemed medically inoperable by an experienced thoracic cancer clinician for a standard lobectomy and lymph node sampling/dissection. Inoperability may be defined utilizing a number of criteria. These include any of the following:
• Pretreatment Forced Expiratory Volume (FEV1) \< 40% predicted
• Postoperative FEV1 \< 30% predicted
• Severely reduced diffusion capacity
• Baseline hypoxemia and/or hypercapnia
• Exercise oxygen consumption \< 50% predicted
• Severe pulmonary hypertension
• Diabetes mellitus with severe end organ damage
• Severe cerebral, cardiac, or peripheral vascular disease
• Decline surgery after evaluation by a thoracic surgeon
• Required laboratory values within 2 weeks of chemotherapy initiation

You may not qualify if:

• Primary lesion size not within the acceptable criteria
• Evidence of regional metastases or distant metastases following appropriate staging
• Previous radiation to the chest
• Chemotherapy within the previous five years
• Previous surgery for this particular lung tumor
• Plans for concomitant chemotherapy with radiation
• Active systemic or pulmonary infection
• Pregnant or lactating females
• Synchronous primary malignancy or prior malignancy in the past 2 years except for invasive malignancy that has been treated definitively and the patient remains disease free for \> 3 years with life expectancy \> 3 years. Previous skin cancers and carcinoma in situ treated definitively are acceptable.
• Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology
• Bronchioloalveolar cell carcinoma is excluded because assessment of multifocal disease spread through the airways is difficult
• Receipt of any other investigational agents or participation in any other investigational drug study within 4 weeks preceding initiation of study treatment

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Goetz H Kloecker, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 21, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)