Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

Study summary

Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFractionated radiation therapy followed by chemotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 2, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Virginia Commonwealth University

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Virginia Commonwealth University
Interventions being studied: Radiation: Fractionated radiation therapy followed by chemotherapy

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Treatment approach

Chemotherapy→Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patients with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified.
Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes.
18-fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning.
Atelectasis, if present, must be less than one lung.
Patients must have granulocytes \>1500/µl; platelets \>100,000/µl; bilirubin \< 1.5 mg/dl; AST(SGOT) \< 2 ULN; serum creatinine \< 2.0 mg/dl.
Zubrod Score 0-1.
FEV1 must be \>1.0 L.
Patients must sign a study-specific informed consent form prior to study entry
Patients must have measurable disease on the planning CT.
Patient must have a completed the IMRT plan and the attending physician must have reviewed and approved the dose volume histograms as follows (based on treatment planning to the Phase 4 dose level): total lung V20 \< 30%, mean esophageal dose \< 34 Gy, the esophageal V55 \< 30%, the heart V40 \< 50%.
No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more; no prior lung cancer within last two years.
No prior RT to thorax.
No previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
No distant metastases or supraclavicular lymph node involvement or significant atelectasis.
No clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.

Reasons someone may not be able to joinExclusion criteria

Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage.
Stage I, II or IV NSCLC.
Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more.
Prior radiation therapy to the thorax.
Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
Distant metastases or supraclavicular lymph node involvement, or atelectasis of an entire lung.
Patients who have not had the pre-treatment evaluations in Section 4.0 or evaluations performed \> 8 weeks prior to study entry.
Patients with clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.
Prior lung cancer within the last two years.
Patients who have significant atelectasis and in whom the CT definition of the gross tumor volume(GTV) is difficult to determine.
Pregnant or lactating females. It is not known what effects this treatment may have on the developing fetus.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Massey Cancer CenterRichmond, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 2, 2016. Always confirm current availability with the study team.

View original record ↗