What side effects are associated with this type of intervention?

The most common treatments for retroperitoneal sarcoma include surgery, conventional radiation therapy, and advanced radiation techniques such as Intensity-Modulated Radiation Therapy (IMRT) and Proton Beam Radiation Therapy. Surgery can lead to complications like infection, bleeding, and damage to surrounding organs. Conventional radiation therapy often results in side effects such as fatigue, skin irritation, and damage to nearby healthy tissues, potentially causing gastrointestinal and urinary issues. Advanced radiation techniques like IMRT and Proton Beam Radiation Therapy aim to minimize these side effects by delivering more targeted radiation doses, reducing the risk of damage to normal tissues. However, patients may still experience fatigue, skin reactions, and localized pain.

What prior FDA approvals exist?

Retroperitoneal sarcomas are typically treated with surgery, often combined with radiation therapy to improve outcomes. Proton beam radiation therapy, which is FDA-approved, offers a targeted approach that minimizes damage to surrounding healthy tissues. This method is particularly beneficial for retroperitoneal sarcomas due to its precision. While specific FDA-approved drugs for retroperitoneal sarcoma are not detailed, treatments often include chemotherapy agents like doxorubicin and ifosfamide, which are used in various sarcoma subtypes.

What other types of research exist?

Promising alternatives to Proton Beam Radiation Therapy for Retroperitoneal Sarcoma patients include Intensity-Modulated Radiation Therapy (IMRT) and Carbon Ion Radiotherapy. IMRT allows precise targeting of the tumor while sparing surrounding healthy tissue. Carbon Ion Radiotherapy, although less widely available, has shown similar efficacy to PBRT and may offer benefits in terms of local control and reduced toxicity.

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Proton Beam Therapy

Proton vs Photon Radiation for Retroperitoneal Sarcoma

Phase 1 & 2

Recruiting

Led By Thomas F. DeLaney, M.D.

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven primary soft tissue sarcoma of the retroperitoneum

Measurable disease

Must not have

Multifocal disease, lymph node or distant metastases

Other types of sarcomas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's safe to give a higher dose of radiation to people with a type of cancer called retroperitoneal sarcoma. The radiation will be given before surgery to remove the tumor.

Who is the study for?

This trial is for people with a life expectancy over 2 years who have measurable, histologically confirmed primary soft tissue sarcoma in the retroperitoneum. It's not for those previously treated with radiation for this condition, pregnant or breastfeeding individuals, patients on other investigational drugs, those with multifocal disease or metastases, sensitivity to radiation therapy, HIV on anti-retrovirals, uncontrolled illnesses, recent chemotherapy recipients within 4 weeks prior to the study start date.

What is being tested?

The study tests two FDA-approved radiation therapies: proton beam therapy (IG-IMPT) and IMRT before surgery to remove retroperitoneal sarcomas. The goal is to find the safest high dose of these radiations that can be given by targeting most of the tumor and giving an extra boost to higher risk areas.

What are the potential side effects?

While proton radiation aims to minimize side effects by being more targeted than traditional photon-based treatments like IMRT, potential side effects may include skin reactions at the treatment site, fatigue due to energy expenditure during recovery from cellular damage caused by radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of sarcoma that started in the tissue behind my stomach.

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My cancer can be measured by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to lymph nodes or other parts of my body.

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My condition is a type of sarcoma not listed.

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I have had a different cancer than my current one in the last 3 years.

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I am HIV positive and on combination anti-retroviral therapy.

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I do not have any uncontrolled illnesses.

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I have had radiation therapy for sarcoma in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Determine MTD

Phase II: Determine Local Control Rate

Secondary study objectives

Overall Survival

Pathologic Response

Progression-Free Survival Times

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Arm IMRTExperimental Treatment1 Intervention

IG IMRT with SIB to the high risk margin

Group II: Treatment Arm IMPTExperimental Treatment1 Intervention

IG-IMPT with SIB to the high risk margin

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Retroperitoneal Sarcoma include surgery, conventional radiation therapy, and advanced radiation techniques such as Intensity-Modulated Radiation Therapy (IMRT) and Proton Beam Radiation Therapy. Surgery aims to remove the tumor entirely, which is crucial for long-term control. Conventional radiation therapy uses high-energy rays to kill cancer cells but can damage surrounding healthy tissue. IMRT and Proton Beam Therapy are advanced forms of radiation that precisely target the tumor while minimizing exposure to normal tissues. Proton Beam Therapy, in particular, uses charged particles that stop at the tumor site, reducing collateral damage. This precision is especially important for Retroperitoneal Sarcoma patients due to the tumor's proximity to vital organs, thereby potentially reducing side effects and improving outcomes.

Efficacy of Postoperative Radiotherapy Using Modern Techniques in Patients with Retroperitoneal Soft Tissue Sarcoma.