A Phase 2 interventional study of Carboplatin and Proton Radiotherapy in Lung Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (such as paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.
A proton beam is made up of charged particles that have a well-defined range of penetration into tissues. How deep it can penetrate is decided by both the beam's energy and the density of the tissue through which it passes. As the proton beam penetrates the body, the particles slow down, and the beam deposits its dose sharply near the end of its range. This is a phenomenon known as the Bragg peak. By adjusting the Bragg peak, the doctor can deliver a full, localized, uniform dose of energy to the treatment site while sparing the surrounding normal tissues. The proton beam is ideal for treatments where organ preservation is very important, such as lung cancer.
If you are found to be eligible to take part in this study, you will receive 37 treatments of proton radiotherapy (Monday through Friday for 7 1/2 weeks). During the treatment, you will lie still on a table for about 30-45 minutes per day in the same position. The proton machine will deliver the dose according to the plan designed by the physician and controlled by a computer. You will not feel, see, or smell anything during the proton beam delivery. While on study, you will also be receiving weekly standard low-dose chemotherapy possibly followed by full-dose chemotherapy.
During the treatment, you will be seen by a doctor and research nurse once a week to evaluate possible side effects. You will have a physical exam and you will have a medical history. About 2 teaspoons of blood will be drawn for routine tests.
You will be taken off study early if the disease gets worse or intolerable side effects occur. After finishing the treatment, 6 week follow up is recommended after completion of radiotherapy, then required every 3 months (+1 month) for 2 years, then every 6 months (+1 month) for 3 years, and then once a year for 2 years. You will have imaging tests (chest CT or positron emission computed tomography (PET) scan) and routine blood tests (about 2 teaspoons) at the follow-up visits.
This is an investigational study. Proton radiotherapy is FDA approved for the treatment of lung cancer. A total of 65 patients will be take part in this study. All will be enrolled at MD Anderson.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 84 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Proton Radiotherapy + Carboplatin + Paclitaxel
Drug: Carboplatin · Radiation: Proton Radiotherapy · Drug: Paclitaxel
2 area under curve (AUC) by vein Weekly
Also known as: paraplatin
2 GY/fraction for 37 fractions (daily treatment, Monday to Friday, for 7.5 weeks).
50 mg/m\^2 by vein Weekly
Also known as: Taxol
Overall Survival and Progression Free Survival
The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care. Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up. Progression-free survival (PFS) was defined from enrollment to any treatment failure or death. PFS will be evaluated by series CT of chest with contrast for every follow up except 6 weeks after the concurrent chemo radiotherapy for two years. Multivariate Cox proportional hazards modeling was used to examine predictors of OS when adjusting for each of the collected potential confounding variables.
Time frame: The Overall survival (OS): From date 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): From date of registration to the date of first documented progression or death up to 5 years.
Inoperable stage III NSCLC with KPS of 70-100, medically fit to receive concurrent and/or induction chemotherapy, weight loss ≤ 10% in the 6 months before diagnosis, provide informed consent. Patients were not enrolled in cases of prior chest radiation therapy and/or pregnancy, with prior and/or concomitant malignant neoplasms.
| Milestone | Concurrent Proton and Chemotherapy |
|---|---|
| Started | 84 |
| Completed | 64 |
| Not completed | 20 |
| Withdrew: Lost to follow-up | 9 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Inappropriate staging | 8 |
The primary objective was to improve overall survival (OS). Patients are recommended to have follow up 6 weeks after completion of concurrent chemo radiotherapy for the evaluation of acute treatment toxicities, then required every 3 months (+ 1 month) for two years, then every 6 months (+ 1 month) for three years and then annually for the rest of their lives, that is standard of care. Statistics were performed with Strata/MP 14.2 software. OS was calculated by Kaplan-Meier Methodology (K-M) from the beginning of enrollment to date of death or last follow-up. Progression-free survival (PFS) was defined from enrollment to any treatment failure or death. PFS will be evaluated by series CT of chest with contrast for every follow up except 6 weeks after the concurrent chemo radiotherapy for two years. Multivariate Cox proportional hazards modeling was used to examine predictors of OS when adjusting for each of the collected potential confounding variables.
| percentage of participants | Concurrent Proton and Chemotherapy |
|---|---|
| Overall Survival at 5 years | 29 |
| Progression Free Survival (PFS) | 12.9 |
| Progression Free Survival at 5 years | 22 |
Collected over From the time of registration to the adverse event start date, assessed up to 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Concurrent Proton and Chemotherapy | 47/64 (73.4%) | 35/64 (54.7%) | 0/64 (0%) |
| Event | Concurrent Proton and Chemotherapy |
|---|---|
| LeukopeniaMetabolism and nutrition disorders | 15/64 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 8/64 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 7/64 |
| EsophagitisGastrointestinal disorders | 7/64 |
| FatigueGeneral disorders | 7/64 |
| DermatitisGeneral disorders | 6/64 |
| AnemiaMetabolism and nutrition disorders | 4/64 |
| DehydrationGeneral disorders | 4/64 |
| Weight lossGeneral disorders | 4/64 |
| HyponatremiaMetabolism and nutrition disorders | 3/64 |
There were 64 out of 84 patients treated under the protocol and evaluable for data analysis.
| Age, Categorical(Participants) | Concurrent Proton and Chemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 44 |
| Age, Continuous(years) | Concurrent Proton and Chemotherapy |
|---|---|
| Median | 70 (37 to 78) |
| Sex: Female, Male(Participants) | Concurrent Proton and Chemotherapy |
|---|---|
| Female | 22 |
| Male | 42 |
| Ethnicity (NIH/OMB)(Participants) | Concurrent Proton and Chemotherapy |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 60 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Concurrent Proton and Chemotherapy |
|---|---|
| United States | 63 |
| Bahamas | 1 |
| Non-small cell lung cancer (NSCLC) histological Subtype(Participants) | Concurrent Proton and Chemotherapy |
|---|---|
| Squamous cell carcinoma | 28 |
| Adenocarcinoma | 25 |
| Non-small cell lung cancer, not otherwise specific | 11 |
| Patients with Stage III Non-Small Cell Lung Cancer Gross tumor volume(cm^3) | Concurrent Proton and Chemotherapy |
|---|---|
| Median | 87 (4.1 to 753.2) |
| Patients with Stage III Non-Small Cell Lung Cancer Karnofsky performance status at diagnosis(units on a scale) | Concurrent Proton and Chemotherapy |
|---|---|
| Median | 90 (70 to 100) |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center