Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) Non-Small Cell Lung Cancer (NSCLC)
3 other identifiers
interventional
38
1 country
2
Brief Summary
The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied. Objectives: To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC. Primary goals:
- 1.Improve 2 years progression free survival at the primary site, and
- 2.reduce acute and chronic toxicity
- 3.Improve disease specific survival at 2 years.
- 4.Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.
- 5.Study the role of biomarkers in predicting therapeutic response and toxicities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 lung-cancer
Started May 2006
Longer than P75 for phase_2 lung-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2006
CompletedFirst Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
July 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2017
CompletedResults Posted
Study results publicly available
January 14, 2019
CompletedJanuary 14, 2019
December 1, 2018
11.1 years
June 28, 2007
February 26, 2018
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival and Progression Free Survival
Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS). Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis.
The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.
Study Arms (1)
Proton Radiotherapy
EXPERIMENTALProton radiotherapy 87.5 CGE with 2.5 Gy/fraction for 35 treatments.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented NSCLC.
- Patients with inoperable centrally located tumors, defined as those within 2 cm of the bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0 (selected stage II with chest wall involvement) NSCLC.
- Performance score KPS 60-100.
You may not qualify if:
- Prior radiotherapy to the chest.
- Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.
- Pregnancy. Patients, both men and women of child bearing potential should use an effective method of birth control throughout their participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Massachusetts General Hospitalcollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is phase I/II one arm study. The focus is safety and tolerability (toxicity). Therefore, there are no results about factors and better or worse outcome.
Results Point of Contact
- Title
- Chang,Joe Y.,M.D. / Radiation Oncology
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Joe Y. Chang, MD, PhD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
July 2, 2007
Study Start
May 4, 2006
Primary Completion
June 14, 2017
Study Completion
June 14, 2017
Last Updated
January 14, 2019
Results First Posted
January 14, 2019
Record last verified: 2018-12