Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832780

Enrollment

Registered

2009-01-30

Start date

2008-01-31

Completion date

2018-12-31

Last updated

2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Non Small Cell Lung Cancer, Solid Tumors

Keywords

Lung cancer, radiation therapy, SBRT, Stereotactic Body Radiation Therapy, Tomotherapy, other solid tumors

Brief summary

The purpose of this study is to determine the response of lung tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety.

Detailed description

The introduction of stereotactic body radiation therapy (SBRT) has allowed safe dose escalation in treatment regimens for cancer. Several studies have shown a radiation dose-response relationship for survival and local control for tumors of the lung, including cancer that originates in the lung (such as non-small cell lung cancer) as well as cancer that metastasizes to the lung. The purpose of this study is to determine the response rate and toxicity of SBRT treatment of patients with lung tumors. This study will use a dose of 60 gray (Gy) in 5 fractions of 12 Gy. This provides a biological equivalent dose with alpha/beta ratio of 10 (BED10) of 132 Gy with the anticipation of achieving local control without increased toxicity. Previous studies have shown that the response rate with SBRT across multiple studies is approximately 50%, with an additional 25-40% of patients having stable disease. We hypothesize that this regimen will achieve a response rate of 70% with grade 3 toxicity of less than 5%.

Interventions

RADIATIONStereotactic Body Radiation

A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs 2. Medically inoperable stage I or II non small cell lung cancer with negative lymph nodes or metastatic cancer to lung with less than or equal to 3 lesions 3. Age greater than or equal to 18 years old 4. Zubrod performance status less than or equal to 1 5. Negative pregnancy test for women of child bearing potential 6. Informed consent 7. Each lesion must be less than or equal to 5 cm in maximal diameter and multiple lesions must be less than or equal to 18 cm for the sum of the diameters in 3 dimensions. Example: 3 lesions each 2+2+2 cm have an aggregate diameter of 18 cm which is acceptable. 8. No prior radiation to lesions being treated 9. For metastatic disease to lung, primary tumor needs to be controlled (no evidence of progression on imaging for at least 2 months).

Exclusion criteria

1. Contraindications to radiation 2. Within or touching the zone of proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi) 3. Pregnant or lactating females who chose to breast feed 4. Patients must have recovered from toxicity of prior therapy 5. Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications 6. Cytologically positive pleural effusion

Design outcomes

Primary

Measure	Time frame	Description
Response Rate (RR):	2 years	RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)

Secondary

Measure	Time frame	Description
Treatment Related Toxicity	2 years	Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.
Overall Survival (OS)	up to 67 months	The time from treatment initiation to death by any cause
Progression Free Survival (PFS)	2 years	The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Clinical Benefit Rate (CBR)	2 years	CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): \>= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).

Countries

United States

Participant flow

Participants by arm

Arm	Count
60 Gy Using 12 Gy Per Fraction Over 5 Fractions Radiation dose of 60 Gy administered in 5 fractions of 12 Gy each.	44
Total	44

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	16
Overall Study	Lost to Follow-up	4
Overall Study	no reason given	2
Overall Study	other complicating condition	2
Overall Study	Physician Decision	1

Baseline characteristics

Characteristic	60 Gy Using 12 Gy Per Fraction Over 5 Fractions
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	30 Participants
Age, Categorical Between 18 and 65 years	14 Participants
Age, Continuous	68.42 years STANDARD_DEVIATION 9.98
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	40 Participants
Region of Enrollment United States	44 Participants
Sex: Female, Male Female	18 Participants
Sex: Female, Male Male	26 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	7 / 44
serious Total, serious adverse events	0 / 44

Arm	Measure	Group	Value (NUMBER)
Stereotactic Body Radiation (SBRT)	Treatment Related Toxicity	cough	4 participants
Stereotactic Body Radiation (SBRT)	Treatment Related Toxicity	fatigue	1 participants
Stereotactic Body Radiation (SBRT)	Treatment Related Toxicity	chest wall pain	7 participants
Stereotactic Body Radiation (SBRT)	Treatment Related Toxicity	shortness of breath	3 participants
Stereotactic Body Radiation (SBRT)	Treatment Related Toxicity	wheeze	1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026