15 Participants NeededMy employer runs this trial

Breath Hold Techniques for Stomach Cancer

(INEX-RT P Trial)

LD
Overseen ByLaura Dawson, MD FRCPSC FASTRO FCAHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using radiation therapy for stomach cancer patients. The aim is to enhance tumor targeting while safeguarding nearby organs by having patients hold their breath in various ways during treatment sessions. This technique might enable doctors to increase the radiation dose to the cancer while protecting nearby organs. Patients with stomach cancer whose tumors are near sensitive organs and who can hold their breath during treatment may be suitable candidates for this study.

As an unphased trial, this study provides patients the chance to contribute to innovative research that could improve future cancer treatments.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this breath hold technique is safe for stomach cancer patients?

Research has shown that radiation therapy (RT), such as the type used in the INEX RT treatment, is generally well-tolerated by stomach cancer patients. Studies on similar radiation methods have demonstrated their effectiveness in targeting cancer cells while protecting healthy tissue. Side effects, or unwanted reactions, can occur, but they are often mild and manageable. Common side effects may include fatigue or skin irritation.

This study is a quality improvement project, focusing on enhancing existing techniques. The goal is to increase the radiation dose to cancer cells while safeguarding nearby healthy organs. This approach aims to deliver better results with minimal additional risk.12345

Why are researchers excited about this trial?

Researchers are excited about the Breath Hold Techniques for Stomach Cancer trial because it explores an innovative method to potentially improve radiation therapy outcomes. Unlike traditional treatments that expose healthy tissues to radiation, this technique aims to limit damage by precisely targeting cancer cells while the patient holds their breath. This could lead to fewer side effects and improved quality of life for patients undergoing radiation therapy. By enhancing the precision of radiation delivery, this approach may also increase the effectiveness of the treatment, offering new hope for those battling stomach cancer.

What evidence suggests that this breath hold technique is effective for stomach cancer?

Research has shown that radiation therapy (RT) can effectively treat stomach cancer, particularly by controlling symptoms such as bleeding and pain. In past studies, more than two-thirds of patients who received RT experienced benefits. This trial will explore techniques like INEX RT, which aim to enhance radiation delivery, allowing a higher dose to cancer cells while safeguarding nearby healthy organs. Special breath-holding methods may increase treatment precision, focusing more accurately on the cancer. Although RT alone might not significantly boost long-term survival, it plays a crucial role in managing symptoms and improving quality of life.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) with abdominal cancer, especially when the tumor is close to important organs. Participants must be able to hold their breath during scans and treatments, need at least 3 sessions of radiation therapy, and be able to understand and consent to the study.

Inclusion Criteria

I will receive at least 3 sessions of radiation therapy.
I am 18 years old or older.
My tumor is close to important organs or areas previously treated with radiation.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive SBRT with inhale and exhale breath holds to optimize radiation dose delivery while minimizing dose to critical organs at risk

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • INEX RT

Trial Overview

The study tests a new way of giving radiation by having patients hold their breath in both inhale and exhale positions during treatment. This aims to better target the tumor while protecting nearby healthy organs compared to standard single-phase breath holds.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ImagingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Palliative radiotherapy for gastric cancer: a systematic review ...

More than two-thirds of patients receiving RT would have a clinical benefit. Low BED regimens appear to be adequate for symptom palliation.

Efficacy of radiotherapy for gastric bleeding associated ... - PMC

RT was an effective modality for gastric bleeding control in gastric cancer, which can be achieved with a short course scheme with five fractions.

Radiation Therapy for Gastric Cancer: An ASTRO Clinical ...

Palliative RT is efficacious for patients with bleeding, pain, and obstruction. Target coverage goals and dose guidance for normal tissues are provided.

Chemoradiotherapy Regimens Show Sufficient Efficacy in ...

In arms 1, 2, and 3, the 1-year overall survival (OS) rates were 74% (95% CI, 64%-85%), 89% (95% CI, 81%-97%), and 84% (95% CI, 76%-93%), ...

Prognostic Determinants and Real-World Survival Outcomes

The research by Allen and colleagues demonstrated that chemoradiotherapy produced better results than chemotherapy in neoadjuvant therapy because 61% compared ...

Radiation Therapy for Gastric Cancer: An ASTRO Clinical ...

This guideline provides evidence-based recommendations addressing the indications for radiation therapy (RT) for gastric cancer in a variety ...

Radiation Therapy for Gastric Cancer: An ASTRO Clinical ...

This guideline provides evidence-based recommendations addressing the indications for radiation therapy (RT) for gastric cancer in a variety of clinical ...

Efficacy and safety of intensity-modulated radiation therapy ...

However, the efficacy of IMRT and 3D-CRT in gastric cancer remains controversial. This study aimed to compare the efficacy and safety of IMRT with those of 3D- ...

NIPS Boosts Overall Survival Over PS in Gastric Cancer ...

Patients with R2 resection in the NIPS group had a median survival of 15.5 months (95% CI, 11.8-NA); in the PS group, those with R2 resection ...

Prediction of Survival and Recurrence Patterns by Machine ...

This study aimed to evaluate the overall survival (OS) and recurrence patterns by machine learning in gastric cancer cases undergoing RT.