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Study on Metformin for Patients with Osteosarcoma and Ewing’s Sarcoma at High Risk of Relapse

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What is this study about?

This clinical trial is focused on studying the use of metformin as a treatment for patients with certain types of bone sarcoma, specifically osteosarcoma and Ewing’s sarcoma, who are at a high risk of the disease returning. Metformin is a medication commonly used to treat diabetes, but in this study, it is being tested to see if it can help prevent the cancer from coming back after initial treatment. The purpose of the study is to evaluate how well patients do without any events, such as the cancer returning, compared to past patients who did not receive this treatment.

Participants in the study will take metformin orally, which means they will swallow the medication in pill form. The study will last for a period of time, during which patients will be monitored to see how they respond to the treatment. The researchers will look at how long patients remain free of cancer and will also check for any unexpected side effects from the medication. Additionally, they will assess how well patients are able to follow the treatment plan using a questionnaire designed to measure quality of life.

The study aims to provide valuable information on whether metformin can be an effective maintenance therapy for patients with high-risk bone sarcoma. By comparing the results with historical data, researchers hope to determine if this approach can improve outcomes for patients who have already undergone surgery or chemotherapy and are currently free of disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, body weight, and medical history related to bone sarcoma.

Screening occurs within 30 days after the end of chemotherapy or surgery for relapse.

2 start of treatment

Treatment begins within 30 days after the screening process.

The medication used is metformin, administered orally.

3 medication administration

The dosage and frequency of metformin are determined by the study protocol and are based on individual patient needs.

The duration of administration is aligned with the study’s objectives to evaluate event-free survival.

4 monitoring and evaluation

Regular monitoring is conducted to assess the patient’s response to the treatment and to identify any unexpected side effects.

Patient compliance with the therapy is evaluated using the EORTC QLQ-C30 questionnaire.

5 completion of the study

The study is estimated to conclude by March 15, 2028.

Final assessments are made to determine the effectiveness of metformin as a maintenance therapy in preventing relapse in bone sarcoma patients.

Who Can Join the Study?

  • Must be 10 years old or older.
  • Must weigh 30 kg or more.
  • Must have localized osteosarcoma with necrosis (dead tissue) of 60% or less after chemotherapy, completed within 45 days.
  • Must have osteosarcoma or Ewing’s sarcoma and be free of disease after the first relapse, within 45 days of surgery or chemotherapy.
  • Must not be part of other clinical trials.
  • Must be able to swallow.
  • Must have a screening done within 30 days after chemotherapy or relapse surgery.
  • Must start treatment within 30 days from the screening.
  • Must have normal kidney function, with creatinine (a waste product) less than 1.3 mg/L and creatinine clearance (a measure of kidney function) of 70 mL/min or more.
  • Must have normal liver function, with serum total bilirubin (a liver function marker) less than 1.2 mg/dL, except for those with Gilbert syndrome (a mild liver condition).
  • Must have AST and ALT (liver enzymes) less than 1.8 times the normal range.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of bone sarcoma. Bone sarcoma is a type of cancer that starts in the bones.
  • Patients who are not at high risk of relapse. Relapse means the return of cancer after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Ortopedico Rizzoli Bologna Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Universita’ Di Pisa Pisa Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
15.03.2021

Trial locations

Metformin is a medication commonly used to treat type 2 diabetes. In this clinical trial, it is being investigated as a maintenance therapy for patients with bone sarcomas, specifically osteosarcoma and Ewing’s sarcoma, who are at high risk of relapse. The goal is to see if Metformin can help improve the time patients remain free from cancer events compared to past data.

Osteosarcoma – Osteosarcoma is a type of bone cancer that typically starts in the long bones, such as those in the arms and legs. It often occurs in teenagers and young adults. The disease begins when bone cells grow uncontrollably, forming a tumor. As it progresses, the tumor can weaken the bone, leading to fractures. It may also spread to other parts of the body, particularly the lungs. Symptoms often include pain and swelling in the affected area.

Ewing’s Sarcoma – Ewing’s sarcoma is a rare cancer that occurs in bones or in the soft tissue around the bones. It is most commonly found in children and young adults. The disease starts when cells in the bone or soft tissue grow abnormally, forming a tumor. As it progresses, it can cause pain, swelling, and sometimes fever. The tumor may spread to other parts of the body, such as the lungs or other bones. Early symptoms can be mistaken for sports injuries or growing pains.

Trial ID:
2024-515639-32-00
Protocol code:
Metformina-Bone
NCT ID:
NCT04758000
Trial Phase:
Therapeutic exploratory (Phase II)

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