Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Adenocarcinoma

Recurrence

Carcinoma, Large Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.

50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.

SBRT (stereotactic body radiotherapy)

SBPT (stereotactic body proton therapy)

Joe Y. Chang, MD, MS, PHD

The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT). Researchers would like to compare the side effects, quality of life, and cancer control.

SBRT and SBPT:

Both SBRT and SBPT affect tumor cells in the same way. SBRT is the more common radiation technique of the two being studied and has been shown to be effective. However, SBRT may cause side effects when the tumor is close to normal organs because the photon does not stop totally after it hits the tumor cells.

SBPT is a type of radiation that uses charged-up particles. This beam of particles can be targeted like a laser to hit a tumor. When the beam travels through tissue, it starts to slow down. Doctors can control how deep the radiation particles go, to make sure that enough radiation hits the tumor being targeted and avoids the surrounding normal organs.

Both forms of radiation will be planned by a radiologist (radiation doctor) who will decide the dosage of radiation and how it will be given. Radiation technicians will follow the doctor's instructions to deliver your doses of radiation. Because your body moves during radiation, both photon and proton beams sometimes may have trouble staying on target. Proton radiation is more affected by the motion of your body than photon radiation. However, your doctors will use many methods to reduce motion.

Study Groups/Therapy:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in a flip of the coin) to 1 of 2 groups. You will have an equal chance of being in either group.

* If you are in Group 1, you will receive SBRT.
* If you are in Group 2, you will receive SBPT.

You will receive 4 treatments of SBRT or SBPT. During the treatment, you will lie still on a table for about 30-45 minutes per day in the same position for 4 days in a row.

You will not feel, see, or smell anything during the photon or proton beam delivery.

If you are randomly assigned to SBPT, a member of the radiation therapy staff will place 1-5 tiny metal pellets (called fiducial markers) around the tumor to help the radiation doctor locate the tumor during the daily proton therapy. The procedure could be done by a bronchoscopy or using a CT-guided needle placement through the chest wall.

Study Visits:

Once a week during the treatment:

* You will be asked about any side effects you may have had.
* You will have a physical exam.
* Your medical history will be recorded.

Length of Study:

You will finish study treatment after the 4th treatment of SBRT or SBPT. You will no longer be able to continue the same SBRT or SBPT to the same lesion if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions during the procedures. However, you can still receive other alternative treatments.

Follow-up Visits:

After the treatment, at 6 weeks, every 3 months (+/-1 month) for 2 years, every 6 months (+/-1 month) for 3 years, and then once a year for the rest of your life you will have follow-up. This follow-up schedule is standard of care.

* You will have a physical exam.
* Your medical history will be recorded.
* You will have a chest CT or PET scan to check the status of the disease.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Between 6 weeks and 6 months after treatment and then 1 time a year for 2 years, you will have a lung function tests.

On the 3rd or 4th follow-up visit and then 1 time a year for 2 years, you will have an ECG. A SPECT scan may be performed on the 3rd or 4th visit if the doctor thinks it is needed.

Your participation on the study will be over once you have completed the follow-up visits for 2 years. After the 2 years follow up, you will be followed according to the standard of care as described above. If the follow-up is at another hospital, the information about your medical history, physical exam, lung function, PET or CT scans will be sent to MD Anderson for review.

This is an investigational study. SBRT and SBPT are FDA approved for the treatment of lung cancer.

Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)

Randomized Phase II Study Comparing Stereotactic Body Radiotherapy (SBRT) With Stereotactic Body Proton Therapy (SBPT) for Centrally Located Stage I, Selected Stage II and Recurrent Non-Small Cell Lung Cancer

Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.

Prospective assessment of positron emission tomography (PET) standardized uptake value (SUV) changes as a measure of treatment response and outcomes. Pulmonary function changes as a function of treatment and response.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

SBRT (Stereotactic Body Radiotherapy)

SBPT (Stereotactic Body Proton Therapy)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to small numbers of subjects to be analyzed none meeting the two year reporting period for analysis.

Joe Chang, MD/Professor, Radiation Oncology Department

Early study termination. Inadequate enrollment and study period to complete analysis per protocol.

Summary of 2-Year Stereotactic Body Radiotherapy (SBRT) and Stereotactic Body Proton Therapy (SBPT) Related Toxicities by Grade 3+ Treatment-related Toxicity

Treatment Response

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Stereotactic body radiotherapy (SBRT) to the whole prostate (36.25 Gy in 5 fractions) with a focal boost (47.5 Gy in 5 fractions) to the MRI-defined dominant tumour nodule.

Radiotherapy

Nicholas J van As, FRCR

Daniel R Henderson, FRCR

Alison C Tree, FRCR

Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland.

Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS))

Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale)

Inclusion criteria

* Prostate cancer patients with any of the following:
* PSA\>20
* Gleason grade 4+3 or higher
* Stage T3a
* Exclusion criteria
* Nodal or metastatic disease
* PSA\>40
* Stage T3b or higher

Study interventions

This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.

The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Stereotactic Prostate Augmented Radiotherapy With Cyberknife

RTOG scale acute GU toxicity will be measured at baseline, end of treatment, then 2,4 and 12 weeks post treatment. The maximal toxicity during follow up is the primary outcome measure.

PSA will be measured 3-6 monthly during study

Royal Marsden NHS Foundation Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)	NCT01511081	Non-small-cell ...	SBRT (stereotac... SBPT (stereotac...	18 Years -	M.D. Anderson Cancer Center
The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife	NCT02145494	Prostate Cancer	Radiotherapy	-	Royal Marsden NHS Foundation Trust
Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)	NCT01511081	Non-small-cell ...	SBRT (stereotac... SBPT (stereotac...	18 Years -	M.D. Anderson Cancer Center
Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)	NCT01511081	Non-small-cell ...	SBRT (stereotac... SBPT (stereotac...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for sbrt (stereotactic body radiotherapy)