Clinical trials are considered a better method for treating desmoid tumors. The evaluation of new drugs, different combinations of treatments, new approaches to radiation therapy or surgery, and new therapies are integrated into desmoid tumor clinical trials. New treatments with better efficacy and safety are the outcome of a clinical trial. The results of the clinical trials have been effective in reducing the symptoms and side effects during the treatment. A recent study focuses on evaluating the safety and efficacy of AL102 in patients with progressive desmoid tumors. The DeFi trial is a phase 3 trial that assesses the effectiveness, safety and tolerability of the investigational drug nirogacestat in people above 18 years of age with progressing desmoid tumors. A recent clinical trial evaluates cryotherapy as a treatment method for desmoid tumors. The efficacy and safety of Imatinib and Vactosertib in patients with advanced desmoid tumors are evaluated.
A clinical trial for desmoid tumors evaluates the safety and effectiveness of the preoperative 5-ALA oral administration and intraoperative tumor bed phototherapy with red light laser as adjuvant therapy on local tumors that recur in patients with desmoid tumors. Volunteers or patients willing to participate in the clinical trials should communicate with their doctor and healthcare team and research expertise to make well decided informed choices regarding participating in the problem while signing informed consent. The volunteers willingly participate as they know the studies are a way to help advance the treatment of desmoid tumors. Eligibility criteria for desmoid tumor clinical trials ensure that the participants are safe, bound to no ill effects, and well-structured research.
Clinical Trials of Desmoid Tumors
Scientists and health care specialists are always looking for better strategies to treat and cure people with desmoid tumors. These specialists create research studies involving volunteers, known as clinical trials, to conduct research and make scientific advances. Clinical trials evaluate and verify new approaches, medications, or devices to treat desmoid tumors or any disease condition. Every medicine or drug approved by the FDA that is presently used was tried and tested in clinical trials.
Clinical trials can be employed for all types of desmoid tumor conditions. Most clinical trials for desmoid tumors focus on experimenting with new treatment options. They learn if a new treatment strategy is safe, effective and better than the existing ones. The tests also evaluate new combinations of treatments, drugs, and other latest approaches in radiation, surgery or other treatments. Some specific studies also focus on creating new treatment plans and medications to manage and relieve symptoms and the possible side effects (short term and long-term) of treatment.
Volunteers are required to carry out clinical trials for desmoid tumors. These people are the first to avail themselves of the new treatments and medications before making them available to the public. But since all these are new, there can be many risk factors associated with these trials. Sometimes people may experience a few to a range of side effects, and there are also chances that the new study may not become successful. People interested in joining clinical trials for desmoid tumors should talk with their doctor or healthcare team and understand all possible pros and cons of the study. This helps people to make informed well-decided choices.
CLINICAL TRIALS FOR DESMOID TUMOURS
Many clinical trials are taking place to find better treatment options for desmoid tumors.
- A recent study focuses on evaluating the safety and efficacy of AL102 in patients with progressive desmoid tumors 1.
- The DeFi trial: the DeFi trial refers to a phase 3 trial that evaluates the efficacy, safety and tolerability of the investigational drug nirogacestat in people above 18 years of age with progressing desmoid tumors. Nirogacestat is a pill capable of inhibiting a specific protein in the body that is known to contribute to the growth of desmoid tumors 2.
- A recent clinical trial evaluates cryotherapy as a treatment method for desmoid tumors 3. The study tries to prove that cryotherapy could be considered a minimally invasive treatment option instead of chemotherapy to treat desmoid tumors, especially in young patients.
- A recent study is evaluating the efficacy and safety of Imatinib and Vactosertib in patients with advanced desmoid tumors.
- A study attempted to observe people diagnosed with desmoid-type fibromatosis for one month closely.
- A clinical trial for desmoid tumors evaluates the safety and efficacy of the preoperative 5-ALA oral administration and intraoperative tumor bed phototherapy with red light laser as adjuvant therapy on local tumors that recur in patients with desmoid tumors 4.
- The evaluation of the highest dose, possible benefits and side effects of tegavivint in treating people with refractory or recurrent solid tumors like desmoid tumors and lymphomas.
Many more clinical trials are taking place to treat better and cure desmoid tumors.
JOINING A CLINICAL TRIAL
People come forward to participate in clinical trials for various reasons. Some patients consider clinical trials the best treatment option because the existing standard ones are not efficient in managing the disease condition. Hence people are often willing to try out clinical trials hoping that it will give them a better result. They join clinical trials with such hopes, even when they are uncertain about the impact of the trial.
Other patients and volunteers join clinical trials to help the trial progress and arrive at a beneficial result. They consider it to contribute to desmoid tumor treatment and cure. They will be aware that they may not benefit from the trial, but they participate with the hope that it will help future patients with desmoid tumors.
Clinical trials cost and insurance coverage for desmoid tumors can vary with the study and its location. In some cases, the costs of participating in clinical trials are reimbursed, whereas, in some others, they are not. So, people wanting to participate in clinical trials must talk with the team that carries out the research and your insurance company to learn more about costs and reimbursement.
In some clinical trials for desmoid tumors, people express the concern that they are not given any treatment but instead a placebo. Placebo refers to a sugar pill usually combined with standard cancer treatment procedures. So, before any study involving a placebo, patients or volunteers should be well informed.
INFORMED CONSENT AND PATIENT’S SAFETY
Volunteers or patients wanting to join clinical trials must talk with their doctor/ healthcare team and research specialists to make well decided informed choices regarding participating in the trial. This is known as informed consent.
Doctors should describe how this trial differs from the standard treatment strategy. What are the benefits and risk factors associated with this study? Explain the eligibility criteria to participate in clinical trials; what is expected of each participating person?
Eligibility criteria for clinical trial of desmoid tumors ensure that the participants are safe, bound to no ill effects, and the research is well-structured. The participant and the research team will together review these criteria.
People who take part in clinical trials for desmoid tumors may withdraw their participation at any point in time due to any personal or medical conditions. It may be because the treatment is not working or giving the desired results, including severe risks and side effects. Experts and scientists would closely monitor clinical trials to look for their good and bad impacts. Also, before participating in clinical trials, people should communicate with the concerned specialists and doctors to know who will manage their treatments and care during the trial and post the trial.
- 1.Napolitano A, Mazzocca A, Spalato Ceruso M, et al. Recent Advances in Desmoid Tumor Therapy. Cancers. Published online August 1, 2020:2135. doi:10.3390/cancers12082135
- 2.Mercier KA, Walsh DM. The initiation, design, and establishment of the Desmoid Tumor Research Foundation Patient Registry and Natural History Study. Rare Tumors. Published online January 2019:203636131988097. doi:10.1177/2036361319880978
- 3.Vora BMK, Munk PL, Somasundaram N, et al. Cryotherapy in extra-abdominal desmoid tumors: A systematic review and meta-analysis. Benjamin RS, ed. PLoS ONE. Published online December 23, 2021:e0261657. doi:10.1371/journal.pone.0261657
- 4.Kenan S, Liang H, Goodman HJ, et al. 5-Aminolevulinic acid tumor paint and photodynamic therapy for myxofibrosarcoma: an in vitro study. J Orthop Surg Res. Published online March 5, 2020. doi:10.1186/s13018-020-01606-9