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

NCT00832780 | Completed Results DMC

• 2 other identifiers: INST 0810NCI-2011-02943
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer; Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate (RR):

  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)

  2 years

Secondary Outcomes (4)

• Treatment Related Toxicity

  2 years

• Overall Survival (OS)

  up to 67 months

• Progression Free Survival (PFS)

  2 years

• Clinical Benefit Rate (CBR)

  2 years

Study Arms (1)

Stereotactic Body Radiation (SBRT)

EXPERIMENTAL

60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days

Radiation: Stereotactic Body Radiation

Interventions

Stereotactic Body Radiation 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%.

Also known as: SBRT

Stereotactic Body Radiation (SBRT)

Eligibility Criteria

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

You may qualify if:

• Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs
• 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
• Age greater than or equal to 18 years old
• Zubrod performance status less than or equal to 1
• Negative pregnancy test for women of child bearing potential
• Informed consent
• 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.
• No prior radiation to lesions being treated
• For metastatic disease to lung, primary tumor needs to be controlled (no evidence of progression on imaging for at least 2 months).

You may not qualify if:

• Contraindications to radiation
• 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)
• Pregnant or lactating females who chose to breast feed
• Patients must have recovered from toxicity of prior therapy
• Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
• Cytologically positive pleural effusion

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

Universtiy of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Links

• New Mexico Cancer Care Alliance
• University of New Mexico Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ben Liem, MD
• Organization: University of New Mexico Comprehensive Cancer Center

BLiem@salud.unm.edu

505-272-0086

Study Officials

• Ben Liem, M.D

  University of New Mexico Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: May 21, 2021
• Results First Posted: May 11, 2018

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)