Trial Outcomes & Findings for Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer (NCT NCT01618838)

Last Updated: 2018-08-22

Results Overview

Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome. No patients had outcome before the trial was terminated.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Planned for 7 years, collected up to 23 months

Results posted on

2018-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	CyberKnife Radiosurgery, Colonoscopy CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy). CyberKnife radiosurgery: Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	CyberKnife Radiosurgery, Colonoscopy CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy). CyberKnife radiosurgery: Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.
Overall Study slow accrual, trial closed prematurely.	4

Baseline Characteristics

Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CyberKnife Radiosurgery, Colonoscopy n=4 Participants CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy). CyberKnife radiosurgery: Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	75.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Planned for 7 years, collected up to 23 months

Outcome measures

Outcome measures
Measure	CyberKnife Radiosurgery, Colonoscopy n=4 Participants CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy). CyberKnife radiosurgery: Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.
Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).	0 Participants

SECONDARY outcome

Timeframe: Planned for 7 years, collected up to 23 months

Population: No patients had outcome before the trial was terminated.

Outcome measures

Outcome measures
Measure	CyberKnife Radiosurgery, Colonoscopy n=4 Participants CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy). CyberKnife radiosurgery: Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.
Proportion of Patients With Rectal Bleeding.	0 Participants

SECONDARY outcome

Timeframe: Planned for 7 years, collected up to 23 months

Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. Data table reports the number of participants who were alive without progression at the end of the study.

Outcome measures

Outcome measures
Measure	CyberKnife Radiosurgery, Colonoscopy n=4 Participants CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy). CyberKnife radiosurgery: Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.
Progression-free Survival	4 Participants

Adverse Events

CyberKnife Radiosurgery, Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sean Collins

Georgetown University Hospital

Phone: 202-444-3062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place