Radiation + Chemotherapy for Salivary Gland Cancer

Recruiting at 301 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Radiation Therapy Oncology Group

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-6.5 weeks

252 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment for salivary gland cancer?

Research shows that intensity-modulated radiotherapy (IMRT) can improve local control of tumors and reduce side effects by sparing healthy tissues, like the salivary glands, in head and neck cancers. This suggests that IMRT, as part of the treatment for salivary gland cancer, may be effective in targeting tumors while minimizing damage to surrounding healthy areas. ^{1 2 3 4 5}

Is the combination of radiation and chemotherapy generally safe for treating salivary gland cancer?

The combination of radiation and chemotherapy can improve survival in high-risk patients, but it also comes with high risks of side effects and requires special expertise and supportive care. Intensity-modulated radiotherapy (IMRT) can help protect salivary glands and improve quality of life, but more studies are needed to fully understand its long-term safety. ^{1 6 7 8 9}

How is the treatment of radiation and chemotherapy for salivary gland cancer different from other treatments?

This treatment combines 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy (IMRT) to better target the tumor while sparing surrounding healthy tissue, which is not typically achieved with conventional methods. Additionally, the use of concurrent chemotherapy may improve local control of the cancer. ^{1 2 3 10 11}

Research Team

Cristina P. Rodriguez, MD

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for patients with high-risk malignant salivary gland tumors removed by surgery. Eligible participants must have certain types of these tumors, no macroscopic disease post-surgery, and be free of distant metastases. They should not have had prior chemo or radiation for this cancer and must meet specific blood count and organ function criteria.

Inclusion Criteria

I had surgery to remove cancer with the goal of curing it within the last 8 weeks.

Patients must meet specific patient characteristics criteria

My cancer has not spread to distant parts of my body.

Exclusion Criteria

Severe, active co-morbidities as defined

Immunocompromised patients

Prior concurrent therapy restrictions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. In Arm I, patients also receive cisplatin IV over 60 minutes on specified days during radiotherapy.

6-6.5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up visits occur at 3, 6, 9, 12, and 24 months, every 6 months for 2 years, and then annually thereafter.

Treatment Details

Interventions

• 3-dimensional conformal radiation therapy
• Cisplatin
• Intensity-modulated radiation therapy

Trial Overview The study is examining the effectiveness of radiation therapy alone versus combined with chemotherapy (cisplatin) in treating patients after surgical removal of salivary gland tumors. It's a randomized trial, meaning patients are randomly assigned to one treatment or the other.

Participant Groups

Group I: Arm II Experimental Treatment 2 Interventions

Patients undergo 3D-CRT or IMRT as in arm I.

Group II: Arm I Experimental Treatment 3 Interventions

Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 6-6.5 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiotherapy.

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Findings from Research

Intensity-modulated radiation therapy (IMRT) allows for more precise radiation delivery in head and neck cancers, improving local control of tumors while minimizing damage to critical structures like the spine and parotid glands.

IMRT has been shown to preserve salivary function by sparing the parotid glands, although there are ongoing concerns about potential side effects, such as difficulties with swallowing and the risk of secondary cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for head and neck cancer. Caglar, HB., Allen, AM.[2007]

References

1. United States pubmed.ncbi.nlm.nih.gov

Salivary gland tumors treated with adjuvant intensity-modulated radiotherapy with or without concurrent chemotherapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The role of intensity-modulated radiotherapy in the treatment of parotid tumors. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Optimisation of radiotherapy for carcinoma of the parotid gland: a comparison of conventional, three-dimensional conformal, and intensity-modulated techniques. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for head and neck cancer. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled trial to compare 3-dimensional conformal radiotherapy to intensity-modulated radiotherapy in head and neck squamous cell carcinoma: Long-term results. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of setup uncertainty on normal tissue sparing with IMRT for head-and-neck cancer. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Errors and hazards in oncology: radiation oncology]. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Hazards and risks in oncology: radiation oncology. [2022]

9. Greece pubmed.ncbi.nlm.nih.gov

Xerostomia and Clinical Outcomes in Definitive Intensity Modulated Radiotherapy (IMRT) Versus Three-dimensional Conformal Radiotherapy (3D-CRT) for Head and Neck Squamous Cell Carcinoma: A Meta-analysis. [2020]

10. Italy pubmed.ncbi.nlm.nih.gov

Update and perspectives on non-surgical treatment of salivary gland malignancies. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Concurrent chemoradiotherapy for locoregionally advanced salivary gland malignancies. [2015]