Trial Outcomes & Findings for A Study of Patients Receiving High-Dose Rate Brachytherapy (NCT NCT00924027)

Last Updated: 2025-09-05

Results Overview

An implant is adequate if 90% of the Gross Tumor Volume (GTV) receives 90% of the dose prescribed and 80% of the Clinical Tumor Volume (CTV) receives 85% of the prescribed dose. An implant is inadequate if the above criteria is not met. A GTV only applies to certain disease sites such as gynecologic cancer that have not been removed by surgery and CTV applies to prostate or gynecologic cancer that have been removed surgically.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).

Results posted on

2025-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Gynecologic (Endometrial & Cervical) Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Prostate Participants received brachytherapy to the prostate.
Overall Study STARTED	28	15
Overall Study Started Brachytherapy	27	14
Overall Study Completed Brachytherapy	26	14
Overall Study Follow-up Period Active	0	0
Overall Study Follow-Up Period Completed	20	14
Overall Study COMPLETED	20	14
Overall Study NOT COMPLETED	8	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gynecologic (Endometrial & Cervical) Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Prostate Participants received brachytherapy to the prostate.
Overall Study Lost to Further Follow-Up	4	0
Overall Study Physician Decision	1	1
Overall Study Withdrawal: Refused further treatment	1	0
Overall Study Withdrawal: Refused to start treatment	1	0
Overall Study Withdrawal: Refused further follow-up	1	0

Baseline Characteristics

A Study of Patients Receiving High-Dose Rate Brachytherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gynecologic (Endometrial & Cervical) n=28 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate n=15 Participants Participants received brachytherapy to the prostate.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	—	—	4 Participants n=4 Participants	18 Participants n=21 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	—	—	11 Participants n=4 Participants	25 Participants n=21 Participants
Age, Continuous	65.8 years STANDARD_DEVIATION 12.4 • n=5 Participants	—	—	68.4 years STANDARD_DEVIATION 7.1 • n=4 Participants	66.7 years STANDARD_DEVIATION 10.8 • n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	—	—	0 Participants n=4 Participants	28 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	—	15 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	—	—	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	—	—	15 Participants n=4 Participants	42 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	—	—	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	—	—	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	—	—	6 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	—	—	8 Participants n=4 Participants	27 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	28 participants n=5 Participants	—	—	15 participants n=4 Participants	43 participants n=21 Participants

PRIMARY outcome

Timeframe: All participants were assessed 1 week after last dose of high dose radiation (HDR) brachytherapy, an average of 1 week (no range).

Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). No participants were accrued to the pulmonary and breast body sites. 27/28 participants were analyzed in the gynecologic group and 14/15 participants were analyzed in the prostate group because one participant in each group withdrew and refused to start treatment.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=27 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate n=14 Participants Participants received brachytherapy to the prostate.	Overall n=41 Participants Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Participants Who Had Adequate High-Quality Brachytherapy Implants Reported Per Strata (Four Body Sites) and Combined Overall	27 Participants	0 Participants	0 Participants	14 Participants	41 Participants

SECONDARY outcome

Timeframe: Assessed at 12 months after radiation

Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). No participants were accrued to the pulmonary and breast body sites. 14/15 participants were analyzed in the prostate group because one participant withdrew and refused to start treatment.

Local control of the prostate is defined as Biochemical recurrence. Biochemical recurrence is a serum prostatic specific antigen (PSA) more than 2 ng/dL above the post brachytherapy nadir, measured by at least 2 PSA measurements separated by 1 month, and the National Comprehensive Cancer Network (NCCN) guidelines.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=14 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate Participants received brachytherapy to the prostate.	Overall Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Prostate Participants With Local Control Biochemical recurrence	0 Participants	—	—	—	—
Number of Prostate Participants With Local Control No recurrence	14 Participants	—	—	—	—
Number of Prostate Participants With Local Control Not evaluable	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Assessed at 12 months after radiation

Population: As pre-specified by the protocol, this outcome measure is reported per strata (body sites). The prostate group were intentionally reported separately because the assessment for local control is different between the prostate (e.g., biochemical recurrence) group and gynecologic (e.g., imaging) group. No participants were accrued to the pulmonary and breast body sites. 27/28 participants were analyzed in the gynecologic group because one participant withdrew and refused to start treatment.

Local control is defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) of the treated site. In diseases where targets can be imaged, response will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria only for local sites. Complete Response is disappearance of the target lesion. Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion taking into account the baseline sum LD. Stable Disease does not qualify for CR, PR, or progression. Progression is interval increase in the maximal dimension of the target lesion. Scoring of local control at each treated site will be based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria. Each site will be scored separately (Only for local sites) and the number of participants with CR, PR, SD will be determined.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=27 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate n=27 Participants Participants received brachytherapy to the prostate.	Overall Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall Stable Disease	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall Complete Response	25 Participants	0 Participants	0 Participants	25 Participants	—
Number of Participants With Local Control Reported Per Strata (Body Sites) and Combined Overall Not Evaluable	2 Participants	0 Participants	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 159 months and 21 days.

The Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Radiation Morbidity Scoring Scheme was used to score late toxicity following brachytherapy. Late toxicities are graded 0-5. Grade 0 is no symptoms. Grade 1 is mild/slight symptoms. Grade 2 is moderate. Grade 3 is severe. Grade 4 is severe/life-threatening. And Grade 5 is toxicity related to death.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=27 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate n=14 Participants Participants received brachytherapy to the prostate.	Overall n=41 Participants Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall Grade 0	0 Toxicities	—	—	0 Toxicities	0 Toxicities
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall Grade 1	8 Toxicities	—	—	17 Toxicities	25 Toxicities
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall Grade 2	14 Toxicities	—	—	15 Toxicities	29 Toxicities
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall Grade 3	1 Toxicities	—	—	1 Toxicities	2 Toxicities
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall Grade 4	1 Toxicities	—	—	0 Toxicities	1 Toxicities
Number of Grades 0-5 Late Toxicity Reported Per Strata (Body Sites) and Combined Overall Grade 5	0 Toxicities	—	—	0 Toxicities	0 Toxicities

SECONDARY outcome

Timeframe: Approximately 16 years

Population: No participants were accrued to the pulmonary and breast group. 27/28 participants were analyzed in the gynecologic group and 14/15 participants were analyzed in the prostate group because one participant in each group withdrew and refused to start treatment.

To help understand and increase the flow of participants receiving brachytherapy, the number of participants who received brachytherapy each year are reported.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=27 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate n=14 Participants Participants received brachytherapy to the prostate.	Overall n=41 Participants Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2009	3 Participants	—	—	0 Participants	3 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2010	2 Participants	—	—	0 Participants	2 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2011	2 Participants	—	—	0 Participants	2 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2012	12 Participants	—	—	0 Participants	12 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2013	4 Participants	—	—	0 Participants	4 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2014	2 Participants	—	—	0 Participants	2 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2015	1 Participants	—	—	0 Participants	1 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2016	1 Participants	—	—	3 Participants	4 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2017	0 Participants	—	—	1 Participants	1 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2018	0 Participants	—	—	7 Participants	7 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2019	0 Participants	—	—	1 Participants	1 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2020	0 Participants	—	—	0 Participants	0 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2021	0 Participants	—	—	1 Participants	1 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2022	0 Participants	—	—	0 Participants	0 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2023	0 Participants	—	—	0 Participants	0 Participants
Number of Participants Accrued Who Received Brachytherapy Each Year Year 2024	0 Participants	—	—	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 12 months after radiation

Population: No participants were accrued to the pulmonary and breast group. And no participants were assessed for adverse events in the prostate group using the CTCv3.0. 26/28 participants were analyzed in the gynecologic group because one participant withdrew and refused to start treatment, and one participant did not complete brachytherapy.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria (CTC v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=25 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate Participants received brachytherapy to the prostate.	Overall n=25 Participants Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria (CTC) v3.0	22 Participants	0 Participants	0 Participants	0 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 12 months after radiation

Population: No participants were accrued to the pulmonary and breast group. 27/28 participants were analyzed in the gynecologic group and 4/15 participants were analyzed in the prostate group because one participant refused to start treatment in each group.

Here is the number of participants with serious and/or non-serious adverse events assessed by the RTOG. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Gynecologic (Endometrial & Cervical) n=27 Participants Participants received brachytherapy to the vaginal cuff or to the cervical or uterine tumor. Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. Participants will be treated with high-dose brachytherapy according to standard oncology practice and the American Brachytherapy Society (ABS) guidelines. Treatment will vary depending on the site of disease treated.	Pulmonary No participants were accrued to this group.	Breast No participants were accrued to this group.	Prostate n=14 Participants Participants received brachytherapy to the prostate.	Overall n=41 Participants Gynecologic (Endometrial \& Cervical), and Prostate combined. No participants were accrued to the pulmonary and breast group. All participants who received HDR brachytherapy were assessed 1-week after last dose.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Radiation Therapy Oncology Group (RTOG)	19 Participants	0 Participants	0 Participants	11 Participants	30 Participants

Adverse Events

Gynecologic (Endometrial & Cervical)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Pulmonary

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Breast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prostate

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Deborah E. Citrin

National Cancer Institute

Phone: 240-760-6206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place