Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (SABR)
This study is currently recruiting participants.
Verified November 2012 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01463423
First received: October 25, 2011
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
Individualized Stereotactic ablative radiotherapy (SABR) has emerged as an important and effective new treatment modality for lung tumors, but optimal dose regimens have not been fully established. Significant toxicity can be observed with the most commonly used dose regimens, implying that developing treatment regimens that optimize treatment based on tumor-specific factors could be of clinical benefit.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Procedure: PET Scan Procedure: CT Scan Procedure: SABR |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (SABR) |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Evaluate local tumor control with individually optimized lung tumor Stereotactic Ablative Radiotherapy (SABR). Tumor control will be assessed by CT, PET-CT, and if appropriate, biopsy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in toxicity from baseline of individually optimized lung tumor SABR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Feasibility of anatomically optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast delivery using gated RapidArc with flattening free filter mode (FFF) in a subset of patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Examine new biomarkers in lung tumor SABR patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determine progression free survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determine metastasis free survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determine overall survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 82 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SABR |
Procedure: PET Scan
Standard of Care
Other Name: Positron emission tomography
Procedure: CT Scan
Standard of Care
Other Name: Computed tomography
Procedure: SABR
Standard of Care
Other Name: Individualized Stereotactic Ablative Radiotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Limited primary or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases
- Up to 4 lesions may be included, with none larger than 5 cm if there are more than one, or up to 7 cm if there is a single tumor
- Both peripheral and central tumors are accepted for this trial.
- Age > 18 years old
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
- Evidence of uncontrolled extrathoracic metastases
- Lung metastases from colorectal cancer
- Contraindication to receiving radiotherapy
- Age < 18 years old. Children are excluded because lung malignancies rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
- Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463423
Contacts
| Contact: Laura Gable | 650-736-0798 | lauraw1@stanford.edu |
Locations
| United States, California | |
| Stanford University Cancer Institute | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Laura Gable 650-736-0798 lauraw1@stanford.edu | |
| Contact: Stanford Cancer Clinical Trials Office 650-498-7061 ccto-office@stanford.edu | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Maximilian Diehn, MD, PhD | Stanford University |
| Principal Investigator: | Bill Loo, MD, PhD | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01463423 History of Changes |
| Other Study ID Numbers: | LUN0048, SU-10202011-8537, 22476 |
| Study First Received: | October 25, 2011 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013