Anal CancerNCT00693173
Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients
An observational study of Anal Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Anal Cancer
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male anal cancer and distal rectal cancer patients 18 years or older.
Who may be able to join
- Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively.
- Any histological grade.
- Age: >18 years.
- Gender: Male patients with average external genitalia.
- Race: Any.
- Language: English speaking only.
Show all 11Show fewer
- Performance status: Good (Karnofsky Performance Status of >60%). (ECOG 0-2).
- UTMB patients
- Stages: Early local disease to locoregionally advanced disease per the 2002 American Joint Committee on Cancer (AJCC) Staging System.
- Anal Cancer: Stages I-IIIB (see Section 11).
- Distal Rectal Cancers that pass the dentate line and into the anal canal only: Stages IIA-IIIC (see Section 11).
Who cannot join
- Histological variants other than those listed above in 4.a.
- Patients with cystocele or abnormal scrotal edema will be excluded. (Although the Genital Drop Technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy).
- 2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0) patients).
- Performance status: Poor (Karnofsky Performance Status of <60%). (ECOG 3-4).
- Non-English speaking patients.
- Prior pelvic radiation.
Show all 9Show fewer
- Prior pelvic malignancy.
- Anal cancer/rectal cancer surgery, except for biopsy at study site.
- Patient's mental condition and social support is such that he can neither understand the nature of the protocol nor comply with its requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77550
About this study
Official title: Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison
The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.
Read the detailed description
This is a study of two different setups when treating a patient with standard of care radiation doses. The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.
Patients will not be randomized or stratified by demographic or disease risk assessment, but treatment will be tailored to stage specific current standards of care.
An extra (non standard of care) CT is required to analyze the data.
- Conditions
- Anal Cancer
- Keywords
- anal, cancer, rectal, IMRT, genital, sparing, drop, technique
- Medical subject headings
- Anus Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique.
The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles, scrotal skin and penile shaft compared to the standard conformal radiation therapy (CRT) and IMRT plans while preserving adequate planned target volume (PTV) dose coverage and homogeneity to the target organs in male anal cancer patients.
Measured: Day 1. Pretreatment analysis.
Secondary outcomes (1)
Dosimetry comparison details.
Testicular dose: Volume receiving 14 Gy was 90% with CRT, 64% with IMRT, and 3% with IMRT-GD.
Testicular dose: Volume receiving 30 Gy was 54% with CRT, 26% with IMRT, and 0% with IMRT-GD.
External genitalia dose: Volume receiving 14 Gy was 93% with CRT, 79% with IMRT, and 35% with IMRT-GD.
External genitalia dose: Volume receiving 30 Gy was 75% with CRT, 31% with IMRT, and 12% with IMRT-GD.
Planning Target Volume receiving full 54 Gy dose was 93% with CRT, 93% with IMRT, and 94% with IMRT-GD.
Measured: Day 1. Pretreatment parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grant R. Seeger, MD, Principal investigator, The University of Texas Medical Branch at Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693173
- Sponsor's protocol ID
- 07-049
- Status last verified
- Feb 2013
- First submitted
- 4 Jun 2008
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison
- ClinicalTrials.gov ID
- NCT00693173
- Acronym / sponsor ID
- 07-049
- Conditions
- Anal Cancer
- Keywords
- anal, cancer, rectal, IMRT, genital, sparing, drop, technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.
Detailed description
This is a study of two different setups when treating a patient with standard of care radiation doses. The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with identical radiation treatment technique and parameters. After the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.
Patients will not be randomized or stratified by demographic or disease risk assessment, but treatment will be tailored to stage specific current standards of care.
An extra (non standard of care) CT is required to analyze the data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male anal cancer and distal rectal cancer patients 18 years or older.
Key inclusion criteria (11 listed)
- Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively.
- Any histological grade.
- Age: >18 years.
- Gender: Male patients with average external genitalia.
- Race: Any.
Key exclusion criteria (9 listed)
- Histological variants other than those listed above in 4.a.
- Patients with cystocele or abnormal scrotal edema will be excluded. (Although the Genital Drop Technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy).
- 2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0) patients).
- Performance status: Poor (Karnofsky Performance Status of <60%). (ECOG 3-4).
- Non-English speaking patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique.
Time frame: Day 1. Pretreatment analysis.
The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles, scrotal skin and penile shaft compared to the standard conformal radiation therapy (CRT) and IMRT plans while preserving adequate planned target volume (PTV) dose coverage and homogeneity to the target organs in male anal cancer patients.
1 secondary outcome
Dosimetry comparison details.
Time frame: Day 1. Pretreatment parameters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Related trials for Anal Cancer
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
RecruitingPhase 2
Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
Anal Canal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant R. Seeger, MD principal investigator
The University of Texas Medical Branch at Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Genital Drop Technique (IMRT-GD) decreased the radiation dose to the testicles scrotal skin and penile shaft compared to standard prone technique. (time frame: Day 1. Pretreatment analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.