CLINICAL TRIAL

Customized Vacuum Immobilization Device (CVID) for Cancer of Rectum

Locally Advanced
Waitlist Available · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether or not the use of a customized vacuum immobilization device (CVID) to immobilize rectal cancer patients undergoing preoperative pelvic radiation therapy improves the positional stability of patients during each radiation treatment.

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About the trial for Cancer of Rectum

Eligible Conditions
Rectal Carcinoma · Rectal Neoplasms

Treatment Groups

This trial involves 2 different treatments. Customized Vacuum Immobilization Device (CVID) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Customized Vacuum Immobilization Device (CVID)
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
prone pillow and simple ankle fixation device
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Any rectal cancer patient who is to receive a 5 week course of preoperative pelvic radiation therapy with or without concurrent chemotherapy
Prone treatment position
Age 18 years or older
Informed consent
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Customized Vacuum Immobilization Device (CVID) will improve 1 primary outcome and 1 secondary outcome in patients with Cancer of Rectum. Measurement will happen over the course of 2 years.

Comparing the use of a prone pillow and simple ankle fixation device vs. the use of a CVID for immobilization rectal patients during the course of preoperative radiation therapy using KV CBCT for IGRT.
2 YEARS
2 YEARS
quantify interfractional set-up displacements using either of the two devices;determine a standard planning target volume margin; evaluate the role of soft-tissue image matching for IGRT using CBCT.
2 YEARS
2 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cancer of rectum?

The signs and symptoms of cancer of rectum are not clearly defined, and are sometimes hard to identify in adults. A thorough history is recommended in order to formulate a differential diagnosis. Screening is only recommended in those with chronic constipation, blood in stool or haemorrhoids. A positive fecal occult blood test is a reliable sign for colorectal carcinoma. The stage of the tumour is crucial in determining the type of surgery, and staging should be done in patients with constipation and faecal occult blood. In those with signs but no symptoms of cancer of rectum, endovaginal ultrasound scanning can be performed.

Anonymous Patient Answer

What are common treatments for cancer of rectum?

In the most extreme cases, surgery or radiation have been the treatments of choice. There are also several alternative and complementary treatments, such as herbal and palliative medicines, acupuncture, cryotherapy, hyperbaric oxygen therapy, transcutaneous electrical nerve stimulation, and meditation.

Anonymous Patient Answer

What causes cancer of rectum?

Colorectal cancer is caused by a variety of factors. Tobacco smoking, a diet high in fat and animal protein, and aflatoxin exposure appear to be linked to a small proportion of cases. Inadequate and chronic bleeding after bowel inspection may be more important. No single factor appears solely to cause most cases.

Anonymous Patient Answer

How many people get cancer of rectum a year in the United States?

Around 20,600 people are diagnosed with CRM in the United States in 2006. The proportion of CRM diagnosed among patients in the United States is higher in men than in women. Median mortality from CRM is 3 months, irrespective of the stage or the tumor site of origin.

Anonymous Patient Answer

Can cancer of rectum be cured?

Cancer of rectum (as well as [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer)) is not cured by surgery, radiation therapy or chemotherapy - or even cure. It is imperative that patients are informed and understand the fact that, as the only cure for [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) is a complete resection, there is no cure for rectal cancer. Treatments used or in development for rectal cancer currently focus on relieving life-threatening symptoms rather than a cure by itself. Clinically advanced rectal cancer typically progresses to liver metastases or distant spread to the lungs and/or brain within 2 years without any treatments. Follow-up care will be essential for these patients, and should be coordinated into their treatment plans to help manage and minimize complications.

Anonymous Patient Answer

What is cancer of rectum?

While a small proportion of cases are diagnosed with malignant lesions within rectal wall, most of these are in fact either squamous cell carcinoma of the colon or adenocarcinoma of the rectum. In contrast to [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer), rectal cancer tends to present with occult cancer cell spread, as compared to colon cancer, where cancer cells are detectable on cytology. The development of MRI and MR colonographic has enabled the detection of occult cancers cells of rectal wall and the detection and staging of rectal cancers. The outcome of locally advanced rectal cancers is not different from colon cancers. Local surgical resection with low anterior resection is effective treatment in some patients. Adjuvant chemoradiotherapy is also an option.

Anonymous Patient Answer

Has customized vacuum immobilization device (cvid) proven to be more effective than a placebo?

cvid has an insignificant therapeutic effect for advanced rectal cancer as measured by TRS. The superiority of cvid is not supported by a clinically significant difference in primary outcome measures, and TRS has a good positive and negative predictive value, which limits the application of personalized treatments at this stage.

Anonymous Patient Answer

Does cancer of rectum run in families?

Results from the present study do not support the concept that there are familial predispositions to [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer), including cancer as rectum, in the Croatian population.

Anonymous Patient Answer

Who should consider clinical trials for cancer of rectum?

Clinical trials of rectal cancer are very scarce and many patients do not know about them. Although they are being designed for certain patient populations, there are other characteristics that make them interesting for all rectal cancer patients. To address this, physicians or nurse specialists should be vigilant to the trial's goals to make them aware of clinical trials, and then give them the opportunity to receive appropriate information.

Anonymous Patient Answer

Is customized vacuum immobilization device (cvid) typically used in combination with any other treatments?

For the most part, cvid was a well tolerated treatment for the management of symptomatic metastatic rectal cancer. The use of cvid in combination with other treatments was limited by the lack of available randomized clinical trials. There is a need for more prospective trials including standard treatment schedules in order to more fully address the role of cvid in the management of rectal cancer.

Anonymous Patient Answer

How quickly does cancer of rectum spread?

Based on our preliminary study, we feel that the rectal wall has a limited role in the spread of advanced rectal cancers and may serve as a local site for anastomotic recurrence.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer of rectum?

There have been many studies investigating different methods for curative treatment of rectovaginal cancer. However, there is limited data regarding adjuvant (or conservative) treatment of this sub type of cancer (Rectal wall and infiltration). Therefore, the present article shows possible treatment pathways based on the results of recent studies.

Anonymous Patient Answer
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