Radiation + Chemotherapy for Salivary Gland Cancer

This trial aims to determine whether combining radiation therapy with chemotherapy is more effective than radiation alone for treating surgically removed salivary gland tumors. The treatments under investigation include 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy, and the chemotherapy drug cisplatin. Suitable candidates have undergone surgery for high-risk salivary gland tumors and show no remaining cancer, but require further treatment to prevent recurrence. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have prior systemic chemotherapy or radiation therapy for salivary gland cancer and cannot use certain growth factors or stimulating agents during radiotherapy.

A previous study demonstrated promising safety results for intensity-modulated radiation therapy (IMRT). Only about 11% of patients experienced cancer recurrence, and side effects like skin irritation were manageable. Another study found that 3-dimensional conformal radiotherapy (3D-CRT) caused side effects that appeared later, but these were similar to those from standard treatments.

Cisplatin, a chemotherapy drug, has been used safely in other cancer treatments. Research has shown that combining cisplatin with another drug was effective and generally safe for patients with salivary gland cancer. However, about 15% of patients experienced a return of cancer in some form.

Most treatments for salivary gland cancer typically involve surgery followed by radiation therapy, sometimes combined with chemotherapy to manage the disease. However, researchers are excited about combining 3-dimensional conformal radiation therapy (3D-CRT) and intensity-modulated radiation therapy (IMRT) with chemotherapy because these advanced radiation techniques can more precisely target tumors. This precision spares healthy tissues and reduces side effects, potentially improving patient outcomes. Additionally, the integration of cisplatin, a chemotherapy drug, during radiation therapy may enhance the effectiveness of the treatment by sensitizing cancer cells to radiation, offering a promising approach over traditional methods.

This trial compares two types of radiation therapy, 3-dimensional conformal radiation therapy (3D-CRT) and intensity-modulated radiation therapy (IMRT), for treating salivary gland tumors. Research has shown that 3D-CRT can reduce dry mouth and protect the parotid glands, which are crucial for saliva production. IMRT has demonstrated better cancer control than 3D-CRT, particularly in more advanced cases. In Arm I of this trial, patients will receive either 3D-CRT or IMRT along with the chemotherapy drug cisplatin, which has about an 18% success rate in treating advanced salivary gland cancer. Although this rate is not very high, cisplatin can help manage the disease when combined with radiation. Arm II involves patients receiving only 3D-CRT or IMRT. Overall, combining these treatments aims to improve survival and control tumor growth after surgery.²⁴⁶⁷⁸