Phase 2
N=38
Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00495040 ↗Enrolled (actual)
38
Serious AEs
5.7%
Results posted
Jan 2019
Primary outcome: Primary: Overall Survival and Progression Free Survival — 85.70; 60; 42.90; 28.10 percentage of participants (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Proton Radiotherapy (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival and Progression Free Survival |
85.70; 60; 42.90; 28.10; 80; 64.40 | — |
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
Secondary goals:
1. Improve disease specific survival at 2 years.
2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.
3. Study the role of biomarkers in predicting therapeutic response and toxicities.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00495040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.