Study of regorafenib as maintenance treatment after first-line therapy in patients with bone sarcomas without remaining disease

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What is this study about?

This study involves patients with bone sarcomas, which are cancers that develop in the bones. The types of bone sarcomas included in this research are osteosarcomas, Ewing sarcomas, chondrosarcomas, undifferentiated pleomorphic sarcomas, leiomyosarcomas, and angiosarcomas. The study focuses on patients who have completed their standard first-line treatment, which typically includes surgery and chemotherapy depending on the specific type of bone sarcoma, and who currently show no signs of remaining disease. The treatment being tested is regorafenib, also known by its code name BAY 73-4506, which is given as a tablet taken by mouth. This medication will be compared against placebo to see if it works better at preventing the cancer from coming back.

The purpose of this study is to determine whether regorafenib is effective as a maintenance treatment in preventing the return of bone sarcomas after patients have completed their initial treatment. Maintenance treatment means continuing therapy after the main treatment is finished to help keep the disease from coming back. The study will measure how many patients remain free from cancer recurrence at 36 months, meaning three years after starting the maintenance treatment. An event in this study would be considered any return of the cancer, whether it comes back in the original location or spreads to other parts of the body.

During the study, patients will be randomly assigned to receive either regorafenib or placebo for up to 12 months. The maximum daily dose of regorafenib that may be given is 120 milligrams. Patients will need to have regular check-ups and laboratory tests to monitor their health and check for any signs of the cancer returning. Women who can become pregnant must use birth control during treatment and for 7 months after the last dose, while men must use birth control during treatment and for 4 months after the last dose. The study will track patients over several years to see how well the treatment works in keeping the cancer from returning.

1 Treatment assignment

After completing standard treatment for bone sarcoma, which included chemotherapy and possibly surgery or radiation, a random assignment will determine whether regorafenib or placebo will be received. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

The assignment will occur at least 4 weeks but no longer than 2 months after the last chemotherapy dose was received.

2 Pre-treatment assessments

Within 7 days before starting the assigned treatment, blood tests will be performed to check blood cell counts, kidney function, and liver function.

For women who can become pregnant, a pregnancy test will be required within 7 days before treatment assignment, and another urine pregnancy test will be needed within 48 hours before taking the first dose of the assigned medication.

3 Medication administration

The assigned medication will be taken by mouth in the form of film-coated tablets.

The medication is regorafenib 40 mg tablets or matching placebo tablets.

Specific dosing instructions, including the number of tablets to take and how often to take them, will be provided by the study doctor.

4 Regular monitoring visits

Regular visits to the treatment center will be required throughout the study period.

During these visits, physical examinations will be performed and blood samples will be collected to monitor health and check for any side effects.

Blood tests will include checks of blood cell counts, kidney function tests (including creatinine and glomerular filtration rate, which measure how well the kidneys are working), liver function tests (including AST, ALT, bilirubin, and alkaline phosphatase, which show how well the liver is functioning), and blood clotting tests (INR and PTT).

If blood clotting medications such as warfarin or heparin are being taken, blood clotting tests will be performed at least weekly until results are stable.

Urine tests will be performed to check for protein in the urine.

5 Imaging assessments

Imaging scans will be performed at scheduled intervals to check whether the cancer has returned.

These scans will look for any signs of disease recurrence, either at the original site or in other parts of the body.

6 Contraception requirements

Women who can become pregnant must use effective birth control methods during the entire treatment period and for 7 months (210 days) after the last dose of the assigned medication.

Men who are sexually active with women who can become pregnant must use effective birth control methods during the entire treatment period and for 4 months (120 days) after the last dose of the assigned medication.

7 Treatment continuation

The assigned medication will be continued as prescribed by the study doctor.

The treatment is intended as maintenance therapy, which means it is given after the main treatment to help prevent the cancer from returning.

The duration of treatment will be determined by the study protocol and individual response to the medication.

8 Long-term follow-up

Follow-up will continue for up to 36 months to assess whether the disease remains in remission.

The main goal is to determine if the assigned medication helps prevent the cancer from coming back during this period.

Who Can Join the Study?

You must be 12 years of age or older at the time you agree to join the study
You must have a confirmed diagnosis of primary bone sarcoma, which is a type of cancer that starts in the bones. This includes types such as osteosarcomas, Ewing sarcomas, chondrosarcomas, undifferentiated pleomorphic sarcomas, leiomyosarcomas, and angiosarcomas
You must have completed your standard treatment for bone sarcoma, which may have included chemotherapy (medicines to treat cancer) before and/or after surgery or radiation, depending on your specific type of bone cancer
Any side effects from your previous treatment must have returned to normal or near normal levels, except for hair loss, anemia (low red blood cell count), and thyroid problems
At least 4 weeks but no more than 2 months must have passed since your last chemotherapy treatment
You must have no evidence of disease or be in complete remission, meaning tests show no signs of cancer. Small lung nodules may be acceptable under certain specific size and number conditions
Your expected survival time must be greater than 12 months
You must have a performance status score showing you can carry out daily activities. For patients under 18 years, the Karnofsky score must be 70 or higher. For adults, the ECOG score must be less than 2
Your blood clotting tests must be within acceptable limits. If you are taking blood thinning medicines like warfarin or heparin, you can still participate with close monitoring
Your bone marrow (tissue inside bones that makes blood cells) must be working well enough to produce adequate numbers of white blood cells, platelets, and red blood cells
Your kidneys must be functioning properly, as shown by blood and urine tests
Your liver must be functioning properly, as shown by blood tests measuring liver enzymes and bilirubin (a substance produced by the liver)
Your body surface area must be at least 1.30 square meters at the time you agree to join the study
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study treatment
If you are a woman who can become pregnant or a man who is sexually active with a woman who can become pregnant, you must agree to use effective birth control during treatment and for several months after your last dose of study medicine
You and your parents (if you are under 18 years old) must sign a document showing you understand the study and agree to participate
You must be willing and able to attend all scheduled visits, follow the treatment plan, and complete required laboratory tests
You must have medical insurance coverage

Who Cannot Join the Study?

Patients who have chordoma, which is a specific type of bone tumor that grows slowly from the spine or skull base
Patients who still have residual disease, meaning there is still cancer remaining in the body after completing standard treatment
Patients who have not completed their standard treatment sequence, which refers to the usual series of treatments recommended for their type of cancer

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Ioasyeax Rafhfmyf Dq Ctyxts Db Mmqyxovqtup	Montpellier	France
Cqekmp Lbmm Bwregq	Lyon	France
Ccpknm Ptft Smkxefu	STRASBOURG, Alsace	France
Akmmteaqzp Pjxwwwhs Htxuqepv Dq Muuclrewk	Marseille	France
Bkujjjqs Uvvhdhkwvz Hrhfyegy Cynrzi	Besançon	France
Iurjlsko dj Cjdbbrlyonsf Hhyideitzfz Uhcwjkmzolrgz dt Skvft Evrejjs (kupyrux	Saint Priest En Jarez	France
Cxdaoc Oxfog Lhilurt	Lille	France
Hmxlaszh Uxlrullpgkyzan Svcorocicf &zyjtpp Hzhdpos dc Hgzheanqlfw	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	11.02.2020

Trial locations

Investigated drugs:

Regorafenib

Regorafenib is a medication used to treat cancer. In this study, it is being tested as a maintenance therapy for patients with bone sarcomas who have completed their first-line treatment. The purpose is to see if this medication can help prevent the cancer from coming back or growing after the initial treatment has been completed.

Investigated diseases:

Bone sarcoma

Bone Sarcoma – Bone sarcoma is a type of cancer that develops in the bones. It occurs when abnormal cells in bone tissue begin to grow and divide uncontrollably, forming a tumor. The disease can start in any bone of the body, though it most commonly affects the long bones of the arms and legs. As the tumor grows, it can destroy normal bone tissue and weaken the bone structure. The cancer may spread from its original location to other parts of the body, particularly the lungs. Bone sarcomas represent a group of different types of bone cancers, with chordoma being one specific type that is excluded from this particular study.

Trial ID:

2024-514637-37-00

Protocol code:

ET18-272

NCT ID:

NCT04055220

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of regorafenib as maintenance treatment after first-line therapy in patients with bone sarcomas without remaining disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?