RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.

This research is investigating a specific way of giving radiation treatment, called ‘hypofractionated radiation therapy’, to patients with a type of cancer called soft tissue sarcoma. This pre-surgery treatment is being tested in older patients, specifically those aged 70 and above, or 'fragile' patients aged 65 to 69. The main goal is to understand how this radiation treatment affects the healing of wounds after surgery. Up to 48 patients will take part, receiving radiation before surgery. Each patient will be carefully monitored for up to three years after their full treatment (radiation and surgery) to track their progress and recovery. This is a Phase 2 study, meaning it's still in relatively early stages of testing, but it's an important step in finding the best care for these patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut Claudius Regaud

Enrolment target

Start

28 Nov 2023

Estimated completion

01 May 2029

Soft Tissue Sarcoma

What is this study about?

This study is looking into a particular type of cancer treatment called soft tissue sarcoma. Sarcomas are rare cancers that can develop in tissues like muscle, fat, nerves, or blood vessels, often in the arms, legs, or body.

Doctors are interested in a specific kind of radiation therapy, called 'hypofractionated radiation therapy,' which involves giving fewer but larger doses of radiation. This treatment is given *before* surgery. The main aim is to see how this approach affects how well wounds heal after surgery, particularly in older people. The study focuses on patients aged 70 or older, and those aged 65 to 69 who might be ‘fragile’ – meaning they have other health conditions that make them less able to cope with demanding treatments. We know that older and more fragile patients sometimes react differently to treatments, so finding the best and gentlest approach is very important.

By carefully studying how these specific patients respond to this radiation treatment before their surgery, doctors hope to improve care, reduce complications, and help patients recover better. This research could lead to more tailored and effective treatments for older people with soft tissue sarcoma, helping them to live healthier lives after their cancer treatment.

Key takeaways

Targets older patients (70+) or 'fragile' (65-69) with soft tissue sarcoma.
Investigates a specific radiation therapy given before surgery.
Focuses on wound healing after treatment.
Patients are followed for up to three years.
This is a Phase 2 study, helping to refine treatments.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with soft tissue sarcoma in an arm, leg, or your body. You also need to be aged 70 or older, or between 65 and 70 and considered by your doctor to be 'fragile' due to other health factors. Your doctor will assess your general health.

There are several reasons why you might not be able to join the study. For example, if your sarcoma is in your tummy area (retroperitoneal), head and neck area, or internal organs, you wouldn't be eligible. Also, if you've had radiation treatment in the same area before, or if your cancer has spread to other parts of your body, you wouldn't be able to participate. The study also cannot include patients who need to have chemotherapy at the same time, or those who need a full amputation rather than just removing the tumour.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 70 years or older, or between 65 and 70 and considered 'fragile' by your doctor?
Do you have soft tissue sarcoma in an arm, leg, or your body (not internal organs or head/neck)?
Have you *not* had radiation in the same area before?
Have you *not* had cancer spread to other parts of your body?
Are you able and willing to give your permission to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive hypofractionated radiation therapy. This is a special type of radiation treatment given in fewer, larger doses over a shorter period before your surgery. After the radiation, you will have surgery to remove the soft tissue sarcoma. You will then be followed for up to three years after your full treatment (radiation and surgery). During this time, the medical team will check on your recovery, how your wound is healing, and your general health. This will involve regular visits to the hospital for check-ups and assessments. You can discuss the exact schedule of these visits and what they involve with the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a specific type of radiation therapy that may improve wound healing outcomes for older or 'fragile' patients. However, like all medical treatments, there are potential risks and side effects associated with radiation therapy and surgery. The study team will explain these in detail, ensure you understand them, and monitor you closely throughout. Choosing to participate is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (11)

Institut Bergonie
Verified postcode
Bordeaux, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
Chu de Limoges
Verified postcode
Limoges, France· Recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Recruiting
Institut Regional Du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Recruiting
Chu de Poitiers
Verified postcode
Poitiers, France· Recruiting
Institut de Cancerologie de L'Ouest
Verified postcode
Saint-Herblain, France· Recruiting
Chu de Toulouse
Verified postcode
Toulouse, France· Recruiting
IUCT-O
Verified postcode
Toulouse, France· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is 'hypofractionated radiation therapy'?

It's a way of giving radiation treatment using fewer, but stronger, daily doses compared to standard radiation.

Why are they focusing on older/fragile patients?

Older or 'fragile' patients may react differently to treatment, so this study aims to find the best and safest approach for them.

What is 'soft tissue sarcoma'?

It's a rare type of cancer that can grow in soft parts of the body like muscles, fat, nerves, or blood vessels.

Will I have chemotherapy in this study?

No, patients receiving or needing chemotherapy are not included in this particular study.

How long will I be followed after treatment?

You will be followed by the study team for up to three years after your full treatment (radiation and surgery) is complete.

How to find out more

Justine ATTAL KHALIFA

attalkhalifa.justine@iuct-oncopole.fr 05 31 15 54 38 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.