Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Pain

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row. Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.

12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV). Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.

Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.

Hypofractionated Radiation Treatment

12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV).

One Radiation Treatment

Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.

Questionnaire

Quynh-nhu Nguyen, MD

The goal of this clinical research study is to learn if 1 large dose of radiation therapy is better at controlling pain from cancer that has spread to the bones than 10 smaller doses of radiation. Researchers also want to learn if 1 large dose of radiation therapy can help decrease the use of drugs to control the pain, and if it can help to control the disease.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive 1 radiation treatment a day for 10 days in a row (not counting weekends or holidays). You will receive a higher total dose of radiation than Group 2.

If you are in Group 2, you will receive 1 radiation treatment given on 1 day.

Radiation Therapy:

You will lie on a table for the radiation treatment(s). Each treatment will last about 30 minutes.

Length of Treatment:

You may receive 1 or 10 radiation treatments, depending on which group you are in. You will no longer be able to receive radiation therapy if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

At Months 3, 6, 9, 12 and every 3 to 6 months after the start of radiation therapy, you will have x-rays, a bone scan, CT scan, or MRI to check the status of the disease.

At Months 3, 4, and 6 and then every 3 months after that for at least 3 years, you will complete the questionnaires about the pain, your pain relief, and your quality of life. The questionnaires can be filled out at a clinic visit or sent back in the mail.

This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. It is investigational to compare the number and size of radiation doses.

Up to 300 participants will take part in this multicenter study. Up to 300 participants will be enrolled at MD Anderson.

A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms

Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Statistical tests in treatment group were based on the Wilcoxon rank sum test to compare changes in pain scores and analgesic use at each assessment point relative to baseline. Increases or decreases of 2 or more points on a scale of 0 to 10 indicated improving or worsening pain. Fisher exact tests were used to compare the distribution of pain responders (CR + PR) and nonresponders (PP + IR).

Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Complete response (CR) is a pain score of 0 at the treated site and no increase in analgesic. Partial response (PR): reduction in pain score of 2 or more points above baseline with no increase in analgesic. Pain progression (PP): Increases of 2 or more points on a scale of 0 to 10 or worsening pain. indeterminate response (IR): were all other responses.

Report grade 3 acute (skin, fatigue, flare reaction) and long term (sclerosis, bone ossification, bone fracture rate) toxicity associated with treatment. During radiotherapy, the patient will be examined weekly and acute reactions recorded and toxicity occurring after 3 months of radiation therapy.

M.D. Anderson Cancer Center

3 Gy x 10 fractions; Patients can be treated with 2-D, 3-D, or intensity modulated radiation therapy (IMRT)

Arm 1: the Standard Hypofractionated Regimen (MFRT Group)

12 Gy x 1 fraction or 16 Gy x 1 fractions, depending on the size of the metastases or gross tumor volume (GTV), treated with 2-D, 3-D, or IMRT

Arm 2: Single-fraction Stereotactic Radiation (SBRT Group)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

≤4

Number of Lesions

Abdomen

Thorax

Extremities

Head/Neck

Pelvis

Spine

Site of Bony Mets

Numbers of Sites Irradiated

KPS 50-60

KPS 70-80

KPS 90-100

KPS 100: normal activity, 90: able to carry on normal activity, 80: normal activity with effort; 70: unable to carry on normal activity; 60: Requires occasional assistance, 50: Requires frequent assistance and medical care. The KPS was to allow physicians to evaluate a patient's survival. The higher KPS scores, the better treatment outcome.

Karnofsky performance score (KPS)

Adrenal-cortical

Bladder

Breast

Esophagus

Head and Neck

Liver

Lung

Pancreas

Prostate

Renal Cell

Thymoma

Thyroid

Unknown/Lung

Uveal Melanoma

Multiple Myeloma

Primary Cancer Site

Adenocarcinoma

Adenoid Cystic

Adrenal Cortical Carcinoma

Atypical Carcinoid

Carcinoma

Clear Cell

Ductal Carcinoma

Lobular Carcinoma

Melanoma

Neuroendocrine

Papillary

Pleiomorphic Carcinoma

Poorly Diff Carcinoma

Sarcomatoid

Small Cell

Squamous

Urothelial Carcinoma

Other

Primary Tumor Histology

Dr. Quynh-Nhu Nguyen, MD,Associate Professor, Radiation Oncology Department

Pain Response (CR+PR) at 2 weeks

Pain Response (CR+PR) at 1 month

Pain Response (CR+PR) at 3 months

Pain Response (CR+PR) at 6 months

Pain Response (CR+PR) at 9 months

Number of Intent- to- Treat Patients With Pain Response by Treatment

Number of Evaluable Participants With Pain Response by Treatment

Nausea

Vomiting

Fatigue

Radiation Dermatitis

Fracture

Number of Participants With Toxicity Associated With Treatment

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

All Drugs and Chemicals

Androgens

Standard Radiation Treatment

Hypofractionated radiation treatment

Albert Murtha

Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.

Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.

AHS Cancer Control Alberta

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Randomized Trial Evaluating Rapid Delivery of Dose Escalated Hypofractionated Radiotherapy for Patients Diagnosed With Bone Metastases for Effective Palliation of Symptoms	NCT02163226	Bone Metastases	Hypofractionate... One Radiation T... Questionnaire	18 Years -	M.D. Anderson Cancer Center
Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients	NCT01488968	High-risk Prost...	Standard Radiat... Hypofractionate...	18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for hypofractionated radiation treatment