Active not recruitingPHASE3INTERVENTIONAL

PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

This study, called PORTEC-4a, is looking at women with certain types of early-stage womb cancer. It compares the usual way of deciding on treatment after surgery (radiotherapy) with a new method. The new method uses a more detailed look at the cancer’s unique make-up (molecular profile) alongside other information. This helps doctors figure out if a patient needs no further treatment, a specific internal radiotherapy (vaginal brachytherapy), or external radiotherapy. The aim is to give patients the most effective treatment for their individual cancer, avoiding unnecessary treatments for those who don’t need them, while making sure those at higher risk get the right care to prevent the cancer from returning. It's a big step towards more personalised cancer care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Leiden University Medical Center

Enrolment target

550

Start

10 Jun 2016

Estimated completion

31 Dec 2028

Endometrial Cancer Stage I Endometrial Cancer Stage II

What is this study about?

This important study, known as PORTEC-4a, is exploring how to best care for women who have had surgery for early-stage womb cancer. After surgery, some women may need more treatment, called 'adjuvant therapy,' to reduce the chance of the cancer coming back. Traditionally, doctors decide on this extra treatment based on features like the cancer's size and how far it has grown.

However, we now have new ways to look at the cancer cells in much more detail – almost like getting a unique fingerprint of the tumour. This study is testing if using this detailed information about a cancer's 'molecular profile' (its unique make-up at a tiny, genetic level), alongside the traditional factors, can help doctors make even better decisions. The idea is to find out if someone needs no further treatment, a specific internal radiotherapy called vaginal brachytherapy, or external beam radiotherapy.

By understanding each cancer more precisely, doctors hope to give patients the right amount of treatment: enough to effectively lower the risk of the cancer returning, but not so much that patients receive unnecessary therapy with potential side effects. This could lead to more personalised and effective care for women with womb cancer.

Key takeaways

Compares standard treatment with a new, personalised approach for womb cancer.
Uses detailed cancer information (molecular profile) to guide treatment.
Aims to give the right treatment – no treatment, internal, or external radiotherapy.
Could help avoid unnecessary treatments for some patients.
Focuses on early-stage endometrioid womb cancer.
You have a choice to participate and can withdraw at any time.

Who may be eligible?

This study is for women who have had surgery for certain types of womb cancer (specifically, endometrioid type), at early stages (Stage I or Stage II). You might be able to take part if your medical details match specific criteria, such as if your cancer was a certain grade, or if it showed signs of spreading into tiny blood or lymph vessels.

You also need to be generally well enough to take part in a clinical study. Specifically, you wouldn't be able to join if you have certain other types of womb cancer, or if you've had another cancer recently (within the last 5 years, unless it was a very common and less serious skin cancer). Also, if you've had radiotherapy to your pelvis before, or if your follow-up radiotherapy after surgery would be delayed by more than 8 weeks, you wouldn't be eligible.

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.

Have I had surgery for endometrioid womb cancer, Stage I or II?
Am I generally well enough to take part in a study?
Have I had any other cancers in the last 5 years (excluding common skin cancers)?
Have I ever received radiotherapy to my pelvic area before?
Will there be a delay of more than 8 weeks between my surgery and planned radiotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first give your informed consent, meaning you understand the study and agree to participate. You would then be randomly assigned to one of two groups. One group would receive treatment based on the standard approach, which usually involves vaginal brachytherapy. The other group would have their treatment decided using the new, more detailed molecular profile of their cancer, which could lead to no further treatment, vaginal brachytherapy, or external beam radiotherapy.

Your doctors will carefully monitor your progress throughout the study. This will involve regular check-ups and scans, as is usual after womb cancer treatment. The overall duration of your participation will depend on the standard follow-up schedule for your condition, ensuring doctors can track how effectively the treatments prevent the cancer from returning.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a treatment approach that is more tailored to your specific cancer, potentially leading to better outcomes or avoiding unnecessary treatments. However, there's also a chance you might be in the group receiving standard care. Risks associated with treatments like radiotherapy can include temporary side effects such as fatigue, skin irritation, or changes in bowel or bladder habits, depending on the type of radiotherapy. As with all clinical trials, there's no guarantee of personal benefit, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (31)

Medical University, Vienna
Verified postcode
Vienna, Austria
University Hospital Gent
Verified postcode
Ghent, Belgium
CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague
Verified postcode
Prague, Czechia
GINECO group - Institut Goustave Roussy
Verified postcode
Paris, France
Hôpital Européen Georges-Pompidou
Verified postcode
Paris, France
Hôpital Tenon
Verified postcode
Paris, France
Sankt Gertrauden Krankenhaus
Verified postcode
Berlin, Germany
Kaiserswerther Diakonie
Verified postcode
Düsseldorf, Germany
Evang. Kliniken Essen-Mitte
Verified postcode
Essen, Germany
Universitatsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Verified postcode
Lübeck, Germany
Rotkreuzklinikum München
Approximate
Münich, Germany

Common questions

What is 'molecular profiling'?

It's a way of looking at your cancer cells in detail, like their genetic make-up, to understand their unique features and how they might behave.

What is vaginal brachytherapy?

This is a type of internal radiotherapy where a radiation source is placed inside the vagina for a short time to treat the area where the cancer was.

What is external beam radiotherapy?

This is when radiation comes from a machine outside your body, aimed at the area where the cancer was to destroy any remaining cancer cells.

Will I definitely get the new treatment approach?

No, participants are randomly assigned to either the standard treatment group or the group using the new molecular profiling approach to guide treatment decisions.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care or relationship with your doctors.