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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-07923 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
Primary Objectives:
• Pain response will be assessed at 2 weeks, 1 month, 3 months and then every 3 months post-treatment and will be determined based on International Pain Consensus Criteria between the two treatment arms. The 3-month pain response will be used as the primary endpoint in trial design and for powering the test of the study's primary hypothesis of pain response.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Standard Dose | Experimental | Participants will receive either 1 radiation treatment a day for 3 days in a row (not counting weekends or holidays), or Participants will receive 1 radiation treatment given on 1 day. |
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| Arm 2 - High Dose | Experimental | Participants will receive either 1 radiation treatment a day for 5 days, or 1 radiation treatment given on 1 day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Drug | Arm 1: standard 8 Gy delivered in a single fraction or 20 Gy delivered in 5 fractions Arm 2: 16 Gy delivered in a single fraction or 27 Gy delivered in 3 fractions prescribed to planning target volume (PTV). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | through study completion: an average of 1year |
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Inclusion Criteria:
platelets ≥ 40,000/mcL
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
The effects of radiation therapy on the developing human fetus are unknown. For this reason and because radiation therapy as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 weeks after completion of radiation therapy.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quynh Nguyen, M D | Contact | (713) 563-2450 | qnnguyen@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Quynh Nguyen, M D | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2024 | Mar 21, 2025 |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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