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Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium

Primary Purpose

Bladder Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Prophylactic Cranial Irradiation (PCI)

Brain X-ray

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring small cell carcinoma of the bladder, urothelial carcinoma, genitourinary bladder, urothelium, bladder, bladder cancer, prophylactic cranial irradiation, PCI, brain metastasis, genitourinary, radiation, TCC, adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with histologically proven small cell carcinoma of the bladder, or elsewhere along the urothelium, which is locally advanced or metastatic (i.e. > or = cT3b, > or = pT3b, N+, or M+) at the time of presentation or cystectomy who have been treated with chemotherapy.
Patients must have had a response to chemotherapy, which the investigator feels is likely to resulting systemic control of the cancer. In most instances, this would reflect a major response (i.e. > or = 90% reduction of tumor), though a lower percentage may be acceptable if the investigator feels the residual reflects another component, such as transitional cell carcinoma (TCC). Dr Arlene Siefker-Radtke will serve as the final arbiter when questions regarding response arise.
Since small cell tumors of the bladder are often associated with other variant histology including TCC and adenocarcinoma, the presence of variant histology will be allowed.
Patients must be > or = 18 years of age.
Patients may be on other trials (either here at M.D. Anderson Cancer Center or at an outside institution) as long as the other eligibility criteria are met.
Patients must not have any evidence of progressive disease at the time of study entry.
Patients must have an MRI or CT of the head showing no CNS metastases within 6 weeks of study entry.
Patients must have adequate physiologic reserves as evidenced by: a) Zubrod Performance Status (PS) of < or = 2; b) Adequate bone marrow reserves as evidenced by ANC > 1000, and platelet count > 75,000. Supranormal values judged to be of benign or inconsequential etiology will be acceptable.
Patients must be enrolled within 6 months of completing chemotherapy or after surgery of the primary site. Any acute/subacute > or = grade 3 toxicities from the chemotherapy must be resolved to < or = grade 2 at the time of study entry. It is suggested that patients undergo prophylactic cranial irradiation as a soon as they have recovered from chemotherapy or surgery, at a minimum of 2 weeks, and up to 6 months following chemotherapy or surgery.

Exclusion Criteria:

Patients with CNS metastasis at presentation will not be eligible.
History of TIA or stroke within 6 months of study entry.
Prior cranial irradiation.
Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy.

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

Prophylactic cranial irradiation (PCI) treatments to be started within 4 months after the end of chemotherapy or surgery to a total dose of 30 Gy, given at 2 Gy per fraction, 5 days per week for 3 weeks. On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.

Outcomes

Primary Outcome Measures

Brain Metastasis Free Survival

Primary outcome for this trial is the rate of development of brain metastasis by 12 months following start of treatment. A "success" defined as a patient not developing brain metastasis by 12 months following start of treatment. After radiation therapy, participant has an MRI or a CT scan of the brain every 6 months for 1 year.

Secondary Outcome Measures

Full Information

NCT ID

NCT00756639

First Posted

September 18, 2008

Last Updated

May 19, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00756639

Brief Title

Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium

Official Title

Prophylactic Cranial Irradiation (PCI) for Patients With Small Cell Carcinoma of the Urothelium

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 21, 2008 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical research study is to learn if whole brain radiation can lower the chances of developing brain tumors in patients with small cell carcinoma of the urinary tract, including the bladder. The safety of whole brain radiation will also be studied.

Detailed Description

Pregnancy Test: Women who are able to have children must have a negative urine pregnancy test to be eligible for this study. MRI/CT Scans: Within six (6) weeks before having whole brain radiation, you will have a magnetic resonance imaging (MRI) or a computed tomography (CT) scan of your brain to check if brain tumors have developed. Simulation Visit: Before the radiation therapy begins, you will have a "simulation visit" to plan for the radiation therapy. During this session, you will be fitted to a plastic mask to hold your head still during radiation. The mask is made of a material called "thermoplastic" that becomes soft when it is placed in warm water. While this plastic is soft, it will be pulled over your face to make a mold. When the plastic cools down, it will harden again and the mask will be completed. After the mask is made, a CT scan of your head will be done for treatment planning. Radiation Therapy: You will begin radiation within 1 week after the simulation visit. You will have radiation visits Monday through Friday for 3 weeks (15 total therapy visits). Each therapy session will last about 15 minutes. It will take the study staff about 10 minutes to position you on the table and put the mask on. The radiation will be given over 2-3 minutes. On the first day of each week of therapy, you will have a brain X-ray to see if the radiation is being given to the best area. Follow-Up: After the radiation therapy, you will have an MRI or a CT scan of the brain every 6 months for 1 year and then every year for 5 years to check the status of the disease. More frequent scans will be performed if your doctor thinks they are needed. You will also complete a written mental status exam with your doctor every 3-6 months for 2 years and then every year for 5 years. The exam will have a series of tests to check your memory and ability to follow instructions. The test will take about 15 minutes to complete. Length of Study: You may remain on study for as long as you are benefitting. You will be taken off study if your disease gets worse or if intolerable side effects occur. This is an investigational study. The use of radiation to check for brain tumors before they have formed is investigational. Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

small cell carcinoma of the bladder, urothelial carcinoma, genitourinary bladder, urothelium, bladder, bladder cancer, prophylactic cranial irradiation, PCI, brain metastasis, genitourinary, radiation, TCC, adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiation

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Prophylactic Cranial Irradiation (PCI)

Other Intervention Name(s)

Whole Brain Radiation, Prophylactic cranial irradiation, PCI

Intervention Description

Intervention Type

Other

Intervention Name(s)

Brain X-ray

Other Intervention Name(s)

X-ray

Intervention Description

On the first day of each week of therapy, a brain X-ray will done to see if the radiation is being given to the best area.

Primary Outcome Measure Information:

Title

Brain Metastasis Free Survival

Description

Time Frame

At 1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically proven small cell carcinoma of the bladder, or elsewhere along the urothelium, which is locally advanced or metastatic (i.e. > or = cT3b, > or = pT3b, N+, or M+) at the time of presentation or cystectomy who have been treated with chemotherapy. Patients must have had a response to chemotherapy, which the investigator feels is likely to resulting systemic control of the cancer. In most instances, this would reflect a major response (i.e. > or = 90% reduction of tumor), though a lower percentage may be acceptable if the investigator feels the residual reflects another component, such as transitional cell carcinoma (TCC). Dr Arlene Siefker-Radtke will serve as the final arbiter when questions regarding response arise. Since small cell tumors of the bladder are often associated with other variant histology including TCC and adenocarcinoma, the presence of variant histology will be allowed. Patients must be > or = 18 years of age. Patients may be on other trials (either here at M.D. Anderson Cancer Center or at an outside institution) as long as the other eligibility criteria are met. Patients must not have any evidence of progressive disease at the time of study entry. Patients must have an MRI or CT of the head showing no CNS metastases within 6 weeks of study entry. Patients must have adequate physiologic reserves as evidenced by: a) Zubrod Performance Status (PS) of < or = 2; b) Adequate bone marrow reserves as evidenced by ANC > 1000, and platelet count > 75,000. Supranormal values judged to be of benign or inconsequential etiology will be acceptable. Patients must be enrolled within 6 months of completing chemotherapy or after surgery of the primary site. Any acute/subacute > or = grade 3 toxicities from the chemotherapy must be resolved to < or = grade 2 at the time of study entry. It is suggested that patients undergo prophylactic cranial irradiation as a soon as they have recovered from chemotherapy or surgery, at a minimum of 2 weeks, and up to 6 months following chemotherapy or surgery. Exclusion Criteria: Patients with CNS metastasis at presentation will not be eligible. History of TIA or stroke within 6 months of study entry. Prior cranial irradiation. Pregnant women will not be eligible; women of childbearing potential must have a negative pregnancy test before starting therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seungtaek Choi, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Prophylactic Cranial Irradiation (PCI) for Small Cell Carcinoma of the Urothelium

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