Intensity Modulated Radiation Therapy for Prostate Cancer
Study Details
Study Description
Brief Summary
BACKGROUND:
-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.
OBJECTIVES:
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.
ELIGIBILITY:
-This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.
DESIGN:
-
On the first 10 patients, we will perform approximately 5 computed tomography (CT) simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published.
-
If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute dose limiting toxicity (DLT) than patients will be accrued to the next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior, lower dose cohort will be considered the MTD. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
-
Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy. Tissue samples will be processed for complementary deoxyribonucleic acid (cDNA) microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.
-
Anatomic Magnetic Resonance Imaging (MRI) and magnetic resonance (MR) biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated (co-registered) to an MR image of reference. A fiducial marker (gold seed) will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate. If necessary, additional fiducial markers will be placed for prostate localization during treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
BACKGROUND:
-This study represents a progression from findings in four previous National Cancer Institute (NCI) Radiation Oncology Branch (ROB) protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.
OBJECTIVES:
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy (IMRT) to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.
ELIGIBILITY:
-
This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer.
-
Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.
DESIGN:
-
On the first 10 patients, we will perform approximately 5 computed tomography (CT) simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published.
-
If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute dose limiting toxicity (DLT) than patients will be accrued to the next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior, lower dose cohort will be considered the MTD. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
-
Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy. Tissue samples will be processed for complementary deoxyribonucleic acid (cDNA) microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.
-
Anatomic Magnetic Resonance Imaging (MRI) and magnetic resonance (MR) biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated (co-registered) to an MR image of reference. A fiducial marker (gold seed) will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate. If necessary, additional fiducial markers will be placed for prostate localization during treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1- 5040cGy to the lymph nodes 5040Gray (cGy) to the lymph nodes |
Radiation: Radiation
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
| Experimental: Arm 2 - 5400cGy to the lymph nodes 5400Gray (cGy) to the lymph nodes |
Radiation: Radiation
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
| Experimental: Arm 3 - 5900cGy to the lymph nodes 5900Gray (cGy) to the lymph nodes |
Radiation: Radiation
Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients) [At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy]
Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days.
- Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3 [Completion of Treatment, an average of 8.5 weeks]
Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
Secondary Outcome Measures
- Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria [At median follow-up, approximately 28 months following radiation]
Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium).
- Number of Participants With a Dose Limiting Toxicity (DLT) [Within 3 months after completion of radiation]
An acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [Date treatment consent signed to date off study, approximately 8 years and 3.5 months.]
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). 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.
- Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria [At median follow-up, approximately 28 months following radiation]
Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage.
Eligibility Criteria
Criteria
- INCLUSION CRITERIA:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Pathology report confirming adenocarcinoma of the prostate
Risk of lymph node metastasis greater than or equal to15% as defined by the Partin tables or biopsy proven positive lymph nodes
Tumor visible on magnetic resonance imaging (MRI)
No prior surgery, radiation, or chemotherapy for prostate cancer, with the exception of hormone therapy which may be given neoadjuvantly for up to four (4) months.
Age greater than 18 years old and less than 90 years old.
EXCLUSION CRITERIA:
Cognitively impaired patients who cannot give informed consent.
Patients with metastatic disease beyond the pelvis
Contraindication to biopsy
-
Bleeding disorder
-
Prothrombin time (PT)/partial thromboplastin time (PTT) greater than or equal to 1.5 times the upper limit of normal
-
Platelets less than or equal to 50K
-
Artificial heart valve
Contraindication to MRI
-
Patients weighing greater than136 kgs (weight limit for the scanner tables)
-
Allergy to magnetic resonance (MR) contrast agent
-
Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.
Pre-existing and active prostatitis or proctitis
Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kevin A Camphausen, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
More Information
Publications
- Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105.
- Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11.
- 050241
- 05-C-0241
- NCT00278356
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study. |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Period Title: Overall Study | |||
| STARTED | 12 | 3 | 4 |
| COMPLETED | 7 | 2 | 3 |
| NOT COMPLETED | 5 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes | Total |
|---|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | Total of all reporting groups |
| Overall Participants | 12 | 3 | 4 | 19 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
7
58.3%
|
2
66.7%
|
0
0%
|
9
47.4%
|
| >=65 years |
5
41.7%
|
1
33.3%
|
4
100%
|
10
52.6%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
64.14
(7.41)
|
59.37
(20.36)
|
67.68
(2.78)
|
64.13
(9.35)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
12
100%
|
3
100%
|
4
100%
|
19
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
12
100%
|
3
100%
|
4
100%
|
19
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
8.3%
|
0
0%
|
0
0%
|
1
5.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
16.7%
|
2
66.7%
|
0
0%
|
4
21.1%
|
| White |
9
75%
|
1
33.3%
|
4
100%
|
14
73.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
12
100%
|
3
100%
|
4
100%
|
19
100%
|
| Median Prostatic Specific Antigen (PSA) at Diagnosis (ng/ml) [Median (Full Range) ] | ||||
| Median (Full Range) [ng/ml] |
16.65
|
33.4
|
8.95
|
19.67
|
| Median Gleason Score at Diagnosis (scores on a scale) [Median (Full Range) ] | ||||
| Median (Full Range) [scores on a scale] |
8
|
7
|
8
|
7.6
|
Outcome Measures
| Title | Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients) |
|---|---|
| Description | Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days. |
| Time Frame | At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy |
Outcome Measure Data
| Analysis Population Description |
|---|
| 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study. |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes |
|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Measure Participants | 6 |
| Week 1 |
5
41.7%
|
| 1 month |
3
25%
|
| 2 months |
4
33.3%
|
| 3 months |
2
16.7%
|
| 6 months |
3
25%
|
| 9 months |
4
33.3%
|
| 1 year |
2
16.7%
|
| 18 months |
0
0%
|
| 2 years |
3
25%
|
| 30 months |
1
8.3%
|
| 3 years |
1
8.3%
|
| Title | Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3 |
|---|---|
| Description | Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation. |
| Time Frame | Completion of Treatment, an average of 8.5 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The MTD of this study was not reached. The original principal investigator left the National Institutes of Health and we are unable to determine why the outcome was not met. |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGY to the Lymph Nodes |
|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes. | Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes. |
| Measure Participants | 0 | 0 | 0 |
| Title | Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria |
|---|---|
| Description | Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium). |
| Time Frame | At median follow-up, approximately 28 months following radiation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Measure Participants | 12 | 3 | 4 |
| Gastrointestinal |
1
8.3%
|
0
0%
|
0
0%
|
| Genitourinary |
3
25%
|
0
0%
|
0
0%
|
| Title | Number of Participants With a Dose Limiting Toxicity (DLT) |
|---|---|
| Description | An acute Dose Limiting Toxicity (DLT) will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation. |
| Time Frame | Within 3 months after completion of radiation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Measure Participants | 12 | 3 | 4 |
| Gastrointestinal |
1
8.3%
|
1
33.3%
|
0
0%
|
| Genitourinary |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
|---|---|
| Description | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). 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. |
| Time Frame | Date treatment consent signed to date off study, approximately 8 years and 3.5 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes |
|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. |
| Measure Participants | 12 | 3 | 4 |
| Count of Participants [Participants] |
12
100%
|
3
100%
|
4
100%
|
| Title | Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria |
|---|---|
| Description | Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage. |
| Time Frame | At median follow-up, approximately 28 months following radiation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGY to the Lymph Nodes |
|---|---|---|---|
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes. |
| Measure Participants | 12 | 3 | 4 |
| Gastrointestinal |
1
8.3%
|
1
33.3%
|
0
0%
|
| Genitourinary |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Date treatment consent signed to date off study, approximately 8 years and 3.5 months. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes | |||
| Arm/Group Description | 5040 Gray (cGy) to the lymph nodes External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5400cGy to the lymph nodes External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | 5900cGy to the lymph nodes External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes. | |||
All Cause Mortality |
||||||
| Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/3 (0%) | 0/4 (0%) | |||
Serious Adverse Events |
||||||
| Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/12 (8.3%) | 1/3 (33.3%) | 0/4 (0%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhea | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Infections and infestations | ||||||
| Infection with normal ANC or Grade 1 or 2 neutrophils::Liver | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Arm 1- 5040cGy to the Lymph Nodes | Arm 2 - 5400cGy to the Lymph Nodes | Arm 3 - 5900cGy to the Lymph Nodes | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/12 (100%) | 3/3 (100%) | 4/4 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Leukocytes (total WBC) | 1/12 (8.3%) | 1 | 1/3 (33.3%) | 1 | 3/4 (75%) | 3 |
| Lymphopenia | 4/12 (33.3%) | 4 | 2/3 (66.7%) | 3 | 4/4 (100%) | 12 |
| PTT (Partial Thromboplastin Time) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Platelets | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 3/4 (75%) | 3 |
| Edema: limb | 0/12 (0%) | 0 | 2/3 (66.7%) | 2 | 0/4 (0%) | 0 |
| Hemoglobin | 5/12 (41.7%) | 5 | 1/3 (33.3%) | 1 | 1/4 (25%) | 2 |
| Neutrophils/granulocytes (ANC/AGC) | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Cardiac disorders | ||||||
| Hypertension | 2/12 (16.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Hypotension | 1/12 (8.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Cardiac General - Other (heart murmur) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Endocrine disorders | ||||||
| Hot flashes/flushes | 9/12 (75%) | 20 | 3/3 (100%) | 4 | 2/4 (50%) | 2 |
| Endocrine - Other (breast tenderness) | 2/12 (16.7%) | 2 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Endocrine - Other (® thyroid size increased) | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Gastrointestinal disorders | ||||||
| Diarrhea | 3/12 (25%) | 4 | 0/3 (0%) | 0 | 1/4 (25%) | 3 |
| Dysphagia (difficulty swallowing) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Flatulence | 2/12 (16.7%) | 2 | 0/3 (0%) | 0 | 1/4 (25%) | 2 |
| Gastrointestinal - Other (Anal lesion - HPV virus (Bx on 1/28/18)) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (Diarrhea) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (Diarrhea, mucous discharge, abdo pain) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (Esophageal cancer) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (Urgency, abdominal pain) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (dysuria) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (frequency) | 2/12 (16.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (increased bowel frequency) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (loose stools; frequency) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (mild BRBPR (hemorrhoids stable)) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (moderate diarrhea) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (moderate diarrhea, frequency, mucous) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (moderate frequency, urgency) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (rectal bleeding; urgency, frequent watery stools) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Hemorrhage, GI::Rectum | 3/12 (25%) | 4 | 0/3 (0%) | 0 | 1/4 (25%) | 2 |
| Incontinence, anal | 6/12 (50%) | 9 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Nausea | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Pain::Abdomen NOS | 4/12 (33.3%) | 6 | 1/3 (33.3%) | 1 | 3/4 (75%) | 4 |
| Constipation | 2/12 (16.7%) | 2 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (Incontinence) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (blood streaked stool) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (loose stool, urgency) | 1/12 (8.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (loose stools) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 2/4 (50%) | 2 |
| Gastrointestinal - Other (small amount blood in stools) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (urgency) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Hemorrhoids | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Proctitis | 1/12 (8.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Gastrointestinal - Other (frequency, soft BM's; mild abdo cramping) | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| General disorders | ||||||
| Fatigue (asthenia, lethargy, malaise) | 10/12 (83.3%) | 16 | 2/3 (66.7%) | 2 | 2/4 (50%) | 2 |
| Insomnia | 1/12 (8.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Weight gain | 10/12 (83.3%) | 17 | 2/3 (66.7%) | 3 | 0/4 (0%) | 0 |
| Weight loss | 6/12 (50%) | 8 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 |
| Edema: limb | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Immune system disorders | ||||||
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Infections and infestations | ||||||
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Pain - Other (L shoulder) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Pain - Other (R hip) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Pain - Other (Thoracic back pain) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Joint-function | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Pain::Back | 3/12 (25%) | 3 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Pain::Joint | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Pain::Extremity-limb | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Nervous system disorders | ||||||
| Mood alteration::Depression | 3/12 (25%) | 7 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| dizziness | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Renal and urinary disorders | ||||||
| Cystitis | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Hemorrhage, GU::Urinary NOS | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Incontinence, urinary | 4/12 (33.3%) | 4 | 0/3 (0%) | 0 | 1/4 (25%) | 2 |
| Renal/Genitourinary - Other (Dribbling) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Renal/Genitourinary - Other (Dysuria) | 4/12 (33.3%) | 5 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Urinary frequency/urgency | 0/12 (0%) | 0 | 2/3 (66.7%) | 2 | 3/4 (75%) | 5 |
| Urinary retention (including neurogenic bladder) | 8/12 (66.7%) | 10 | 2/3 (66.7%) | 4 | 0/4 (0%) | 0 |
| Renal/Genitourinary - Other (Dysuria, Hematuria) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Renal/Genitourinary - Other (nocturia) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Hemorrhage, GU::Urethra | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Renal/Genitourinary - Other (Weak stream) | 6/12 (50%) | 10 | 3/3 (100%) | 4 | 1/4 (25%) | 1 |
| Renal/Genitourinary - Other (dysuria, nocturia) | 0/12 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Reproductive system and breast disorders | ||||||
| Erectile dysfunction | 8/12 (66.7%) | 8 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Gynecomastia | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Libido | 4/12 (33.3%) | 4 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Orgasmic dysfunction | 6/12 (50%) | 6 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Pain::Breast | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Pain::Pelvis | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Dyspnea (shortness of breath) | 0/12 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Dermatology/Skin - Other (Penis mass) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Hair loss/alopecia (scalp or body) | 3/12 (25%) | 5 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 |
| Hyperpigmentation | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Rash/desquamation | 1/12 (8.3%) | 2 | 0/3 (0%) | 0 | 1/4 (25%) | 1 |
| Rash: acne/acneiform | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | 1/12 (8.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Kevin Camphausen |
|---|---|
| Organization | National Cancer Institute |
| Phone | 240-760-6205 |
| camphausen@nih.gov |
- 050241
- 05-C-0241
- NCT00278356