Rectal CancerPhase 2NCT01142713
The Impact of Patient Positioning and Use of Belly Board on Small Bowel and Urinary Bladder Volume Irradiated in Patients Receiving Radiotherapy for Rectal Cancer: A Prospective Phase II Study
A Phase 2 study testing Patient Position During Radiotherapy in people with Rectal Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Radiotherapy has a significant impact on local control, disease free survival and overall survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is accompanied by side effects, mainly due to the inclusion of the small bowel and urinary bladder in the treatment fields. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Patient Position During Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Dec 2011
- Phase
- Phase 2
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative
Who cannot join
- No exclusion
Trial locations and contacts
1 site in 1 country.
About this study
Radiotherapy has a significant impact on local control, disease free survival and overall survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is accompanied by side effects, mainly due to the inclusion of the small bowel and urinary bladder in the treatment fields.
Two major modalities have been pursued to reduce the volume of small intestine and urinary bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These procedures have failed implementation in daily clinical practice. The second modality aims to save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating the radiotherapy planning procedure. Using the belly board and changing the standard position from supine to prone could achieve this aim; in part due to gravitational displacement of the bowel. Several studies have evaluated the impact of positioning and use of belly board in patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but the prone position with belly board appears promising.
This study carefully evaluates the impact of patient's positioning and belly board on dose volume histogram of small bowel and urinary bladder
Read the detailed description
This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy.
In contrast to previous studies, the clinical target volume and organ at risk will be contouring for three-dimensional planning. With the aid of modern imaging, correlation can be obtained between dose and volume (DVH) since both parameters have an impact on organ tolerance to ionizing radiation.
Thirty patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative will be included (15 patients from each group).
In addition to radiotherapy, the patients will receive concomitant chemotherapy.
Chemotherapy: The chemotherapy will consist of one of the following:
- Capecitabine (Xeloda) 825mg/m2 ×2/day, given every day of radiotherapy.
- 5FU continuous infusion 180 mg/m2, D1-5/week X 5
Radiotherapy:
The clinical target volume (CTV) for preoperative radiotherapy will include the entire rectum and regional lymph nodes. The following lymph nodes will be contoured: peri rectal, pre sacral, obturator, internal iliac and distal common iliac. The contouring of the rectum will start 1 cm above the anal verge until the sigmoid (average 15 cm).
The planning target volume will be included in the CTV + 5mm The following organs at risk will be contoured: small intestine, urinary bladder and femoral joints.
The prescription dose will be: 180cGy/day, 5 times a week for a total 5,040cGy (38b fraction over 6 weeks.
Each patient will undergo two simulations, one in the supine position on a flat table and another in the prone position on belly board. No contrast media will be used. The urinary bladder will be full in an attempt to push the small bowel away from the treatment volume. Three dimensional conformal radiotherapy planning will be done twice (one in each position). Three and four fields plan will be evaluate in each position. Therefore a comparison will be between four plains and the optimal plan will be chose for treatment..
The following parameters will be calculated:
- Total volume of the small bowel
- Total volume of urinary bladder
- Intersection of PTV Volume and of small bowel volume
- Intersection of PTV volume and of urinary bladder volume
- Volume of small bowel included in the treatment volume
- Volume of urinary bladder in the treatment volume
- Conditions
- Rectal Cancer
- Being tested
- Patient Position During Radiotherapy
- Keywords
- Small Bowel Radiotherapy Dose, This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Position During RadiotherapyRadiation
Two simulations, one in the supine position on a flat table and another in the prone position on belly board
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose and irradiated volume of small bowel and urinary bladder
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Eliahu Gez, MD, Principal investigator, TASMCElaihu Gez, MD, Study chair, TASMCEliahu Gez, MD, Study chair, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142713
- Sponsor's protocol ID
- TASMC-10-EG-0681-09-TLV-CTIL
- Status last verified
- Feb 2010
- First submitted
- 10 Jun 2010
- Last updated
- 11 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patient Positioning and Use of Belly Board on Small Bowel and Urinary Bladder Volume Irradiated in Patients Receiving Radiotherapy for Rectal Cancer: A Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT01142713
- Acronym / sponsor ID
- TASMC-10-EG-0681-09-TLV-CTIL
- Conditions
- Rectal Cancer
- Keywords
- Small Bowel Radiotherapy Dose, This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Jun 2010 (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.
Radiotherapy has a significant impact on local control, disease free survival and overall survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is accompanied by side effects, mainly due to the inclusion of the small bowel and urinary bladder in the treatment fields.
Two major modalities have been pursued to reduce the volume of small intestine and urinary bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These procedures have failed implementation in daily clinical practice. The second modality aims to save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating the radiotherapy planning procedure. Using the belly board and changing the standard position from supine to prone could achieve this aim; in part due to gravitational displacement of the bowel. Several studies have evaluated the impact of positioning and use of belly board in patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but the prone position with belly board appears promising.
This study carefully evaluates the impact of patient's positioning and belly board on dose volume histogram of small bowel and urinary bladder
Detailed description
This is a prospective non-randomized open study to evaluate the impact of patient's positioning and use of belly board in rectal radiotherapy.
In contrast to previous studies, the clinical target volume and organ at risk will be contouring for three-dimensional planning. With the aid of modern imaging, correlation can be obtained between dose and volume (DVH) since both parameters have an impact on organ tolerance to ionizing radiation.
Thirty patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative will be included (15 patients from each group).
In addition to radiotherapy, the patients will receive concomitant chemotherapy.
Chemotherapy: The chemotherapy will consist of one of the following:
- Capecitabine (Xeloda) 825mg/m2 ×2/day, given every day of radiotherapy.
- 5FU continuous infusion 180 mg/m2, D1-5/week X 5
Radiotherapy:
The clinical target volume (CTV) for preoperative radiotherapy will include the entire rectum and regional lymph nodes. The following lymph nodes will be contoured: peri rectal, pre sacral, obturator, internal iliac and distal common iliac. The contouring of the rectum will start 1 cm above the anal verge until the sigmoid (average 15 cm).
The planning target volume will be included in the CTV + 5mm The following organs at risk will be contoured: small intestine, urinary bladder and femoral joints.
The prescription dose will be: 180cGy/day, 5 times a week for a total 5,040cGy (38b fraction over 6 weeks.
Each patient will undergo two simulations, one in the supine position on a flat table and another in the prone position on belly board. No contrast media will be used. The urinary bladder will be full in an attempt to push the small bowel away from the treatment volume. Three dimensional conformal radiotherapy planning will be done twice (one in each position). Three and four fields plan will be evaluate in each position. Therefore a comparison will be between four plains and the optimal plan will be chose for treatment..
The following parameters will be calculated:
- Total volume of the small bowel
- Total volume of urinary bladder
- Intersection of PTV Volume and of small bowel volume
- Intersection of PTV volume and of urinary bladder volume
- Volume of small bowel included in the treatment volume
- Volume of urinary bladder in the treatment volume
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with rectal cancer scheduled to receive "rectal radiotherapy", pre or postoperative
Key exclusion criteria (1 listed)
- No exclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Position During RadiotherapyTwo simulations, one in the supine position on a flat table and another in the prone position on belly board | Radiation | – |
Primary outcome
Dose and irradiated volume of small bowel and urinary bladder
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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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.
Eliahu Gez, MD principal investigator
TASMC
Elaihu Gez, MD study chair
TASMC
Eliahu Gez, MD study chair
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient Position During Radiotherapy in people with Rectal Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2010. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliahu Gez, MD (+972-52-7360476, eliahug@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose and irradiated volume of small bowel and urinary bladder (time frame: 30 months). 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 11 Jun 2010.