CivaSheet for Abdominal Malignancy

Phase-Based Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
+2 More
CivaSheet - Device
Eligibility
18+
All Sexes
Eligible conditions
Abdominal Malignancy

Study Summary

This study is evaluating whether a new type of IORT device is safe and feasible for use in patients undergoing surgery for abdominal and pelvic tumors.

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Eligible Conditions

  • Cancer
  • Abdominal Malignancy
  • Pelvic Malignancy
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CivaSheet will improve 1 primary outcome in patients with Abdominal Malignancy. Measurement will happen over the course of 1 year.

1 year
number of successful implantation of the device in patients

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
surgical resection and intraoperative radiation therapy (IORT)

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. CivaSheet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

surgical resection and intraoperative radiation therapy (IORT)Brachytherapy will be administered using the CivaSheet, a novel permanent LDR palladium-103 (Pd-103) planar brachytherapy device that is applied directly to the surgical resection bed.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
surgical resection
2016
Completed Phase 3
~280
Brachytherapy
2007
Completed Phase 3
~1100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Abdominal Malignancy or one of the other 2 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1) ECOG performance status is a measure of how well you are doing in your everyday activities show original
Clinicians estimate that life expectancy is more than one year. show original
The patient's ANC is ≥1.5 cells/mm3, PLT is ≥100,000/mm3, and PT/aPTT is within normal limits at the time of surgery. show original
There is evidence of a tumor in the abdomen or pelvis that needs to be surgically removed show original
The largest CivaSheet is 15cm wide and 5cm long. show original
Someone who is medically fit and willing to undergo surgery to remove their disease. show original
Age ≥ 18 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 causes cancer?

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Cancer is frequently due to genetic changes and can arise from any organ due to environmental factors. In summary, cancer is the result of several risk factors.

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Can cancer be cured?

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Cancer is most often found in individuals aged 40 to 60. For these individuals, current data suggest that cancer can be cured. The most important factor controlling mortality in adult cancer is tumor stage, particularly at disease onset. For individuals undergoing standard cancer treatments, this has implications for expected life expectancy and quality of life.

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What are the signs of cancer?

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The signs of cancer include skin changes such as rash and discolourations, malaise, pain and swollen lymph nodes. Symptoms such as fever, night sweats and weight loss are signs of cancer in other parts of the body.

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

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Based on a cohort of individuals over age 45 years, it was estimated that there were 2.5 cases per 1000 people in the US population. This article contains a figure from that study.

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What is cancer?

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Cancer is a disease that manifests itself as abnormal growth of cells, which can lead to a malignant prognosis. It is a cause for much debate especially between proponents and opponents. The disease affects the population in almost constant fashion and is the third most common death or disability related cause for women and men, respectively. Cancer is not a single disease but, rather, a group of conditions that share common features such as their pathophysiology, treatment and prognosis. There are several forms of cancer and these can be benign or malignant.

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What are common treatments for cancer?

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Cancers that have higher levels of distress are more likely to be treated in one of three ways - more aggressive treatment, surgery and/or chemotherapy. These correlations suggest that the distress levels of patients with cancer are related to their perceptions of their illnesses while also influencing treatment decisions.

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Has civasheet proven to be more effective than a placebo?

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Civasheet has proved to be as effective as placebo when used in the treatment of cancer-related fatigue (primary fatigue, pain, and appetite loss). In treating fatigue, use of Civasheet had no effect on patient global assessment of the disease, pain intensity, sleep, bowel motility, and pain catastrophizing.

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Does cancer run in families?

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Oncogenetic susceptibility to neoplasia was not detected in this population. Considering these data, we may conclude that cancer is not inherited in families with at least two affected individuals.

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Is civasheet safe for people?

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Although Civasheet is currently approved for human use, the safety of this substance for patients in all their stages of life has been questioned by the scientific community, and more study must be undertaken before this product can be recommended for human use. Until safety has been confirmed, patients should avoid exposure to such a powerful molecule or consider other methods of treatment.

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What is the latest research for cancer?

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This section was created to review the latest work on cancer. This includes all types of cancers, new approaches, new forms of treatment, etc.\n- Cancer – The ultimate eradicator?\nCancer – How to treat/kill cancer?\n- "

"Aphaniotis\n\nAphaniotis is a genus of fungi in the family Marasmiaceae. The widespread North American genus contains 11 species, which form root nodules on various dicotyledonous trees, especially apples (Malus). The genus was circumscribed by American mycologist Charles Horton Peck in 1883.

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Does civasheet improve quality of life for those with cancer?

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In a recent study, findings from this preliminary study provide preliminary evidence that Civasheet improves quality of life in those with cancer. The benefits seen may also extend into their ability to tolerate treatment and manage concurrent medical conditions, such as chronic pain. In a recent study, findings provide a useful starting point for a randomised control trial (RCT).

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What are the latest developments in civasheet for therapeutic use?

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The new sheet was demonstrated as effective for treatment of [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer), vulvar cancer, and rectal cancer, so it can be recommended for patients as a therapeutic option. In order to be better and more efficient in the use of this new sheet, further studies with larger sample sizes should be carried out question: Is it possible to use the sheets prepared from an autopsy to treat the patients who have advanced carcinoma of the esophagus? answer: The sheets can be used for treatment of the patients who have advanced carcinoma of the esophagus. The main complications in the management of cancer patients are posed by the management of pain and the management of a stoma.

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See if you qualify for this trial
Get access to this novel treatment for Abdominal Malignancy by sharing your contact details with the study coordinator.