Adjuvant Radiation for Throat Cancer

Recruiting at 1 trial location

Overseen By Azeezat Yekinni

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Metastatic disease, Prior head/neck cancer, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What are the safety concerns for adjuvant radiation in throat cancer treatment?

Adjuvant radiation for throat cancer can cause side effects like oral pain, decreased appetite, difficulty swallowing, dry mouth, fatigue, and hoarseness. In combination with chemotherapy, it may also lead to nausea, vomiting, and mucositis (inflammation of the mouth lining). ^{1 2 3 4 5}

How does adjuvant radiation treatment for throat cancer differ from other treatments?

Adjuvant radiation treatment for throat cancer is unique because it is used after surgery to help prevent cancer recurrence, particularly in advanced stages, by targeting remaining cancer cells with high-energy rays. This approach is different from chemotherapy, which uses drugs to kill cancer cells, and it can be combined with other therapies to improve outcomes, although it may lead to side effects like impaired swallowing and speech. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment ctHPVDNA for throat cancer?

Research shows that ctHPVDNA is a promising tool for monitoring treatment response and detecting recurrence in HPV-related throat cancer. It has high accuracy, sensitivity, and specificity for diagnosing this type of cancer, which suggests it could be effective in guiding treatment decisions. ^{11 12 13 14 15}

Who Is on the Research Team?

Michael Sim, MD

Principal Investigator

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HPV+ squamous cell carcinoma of the oropharynx, who are in good physical condition (ECOG 0-2) and have certain stages of tumor growth. It's open to both smokers and non-smokers with resectable tumors that haven't spread far. Pregnant women, those with recent cancers except some skin/thyroid cases, or previous head/neck cancer/radiation are excluded.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

My tumor is small to medium size and has not spread to my voice box.

My cancer originates in the back of my throat.

Exclusion Criteria

My cancer has spread to distant parts of my body.

I haven't had cancer, except for skin or thyroid cancer, in the last 3 years, or I am cured.

I have HPV-related cancer in my throat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo transoral surgery and neck dissection

1 week

Adjuvant Treatment

Participants receive adjuvant treatment based on ctHPVDNA levels, including observation or radiation therapy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ctHPVDNA

Trial Overview The study tests if lower doses of adjuvant radiation (30 or 40 Gray), guided by ctHPVDNA levels after surgery and neck dissection, work well for patients with HPV-related throat cancer. This phase II trial aims to see if this approach can effectively treat without standard higher radiation doses.

How Is the Trial Designed?

Group I: Adjuvant Radiation 40 Gray Experimental Treatment 1 Intervention

Subjects with positive postoperative ctHPVDNA will undergo reimaging to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation or 30 Gy of radiation depending on nodal status. If repeat ctHPVDNA level is positive, or subject has no obvious operable disease then subject will undergo 40 Gy of radiation.

Group II: Adjuvant Radiation 30 Gray Experimental Treatment 1 Intervention

Subjects with undetectable postoperative ctHPVDNA levels after surgery, negative margins, and five or more positive nodes; or confirmed extranodal extension (ENE) (greater than 2 mm) will undergo deintensified radiation treatment of 30 gray.

Group III: Observation Active Control 1 Intervention

Subjects with undetectable postoperative ctHPVDNA levels and either 4 or fewer nodes will have no further adjuvant treatment.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

The study proposes a new clinical trial to use circulating tumor DNA (cfHPVDNA) levels to identify patients with HPV-associated oropharyngeal squamous cell carcinoma who may safely undergo de-escalated therapy, potentially reducing long-term treatment toxicity.

Patients with undetectable cfHPVDNA after surgery will be categorized into low-risk or high-risk groups, with low-risk patients possibly receiving observation instead of radiation, while high-risk patients will continue with standard adjuvant therapy, aiming to evaluate disease recurrence and survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sinai Robotic Surgery Trial in HPV-related oropharyngeal squamous cell carcinoma (SIRS 2.0 trial) - study protocol for a phase II non-randomized non-inferiority trial. Chai, RL., Ferrandino, RM., Barron, C., et al.[2022]

A meta-analysis of 13 studies involving 998 patients showed that circulating tumor HPV DNA (ctHPVDNA) detected by ddPCR has high sensitivity (90%) and specificity (94%) for diagnosing HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).

The results suggest that ctHPVDNA monitoring could enhance the diagnostic and therapeutic management of cancer patients, providing valuable insights into tumor biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is time to improve the diagnostic workup of oropharyngeal cancer with circulating tumor HPV DNA: Systematic review and meta-analysis. Paolini, F., Campo, F., Iocca, O., et al.[2023]

Weekly dosing of cisplatin significantly reduces the risk of ototoxicity in patients with head and neck squamous cell carcinoma, while maintaining similar progression-free and overall survival rates compared to high-dose cisplatin.

Genetic factors such as the COMT and MATE1 genes can predict ototoxicity risk, with COMT carriers at higher risk and MATE1 A/A carriers showing protection, suggesting that genotyping could help tailor treatment to minimize hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of cisplatin-induced ototoxicity and survival in chemoradiation treated head and neck cancer patients. Teft, WA., Winquist, E., Nichols, AC., et al.[2021]

Adjuvant radiotherapy (RT) significantly improves 5-year overall survival rates for patients with node-positive head and neck squamous cell carcinoma (HNSCC), with survival rates of 46.3% for surgery plus RT compared to 35.2% for surgery alone.

The benefits of adjuvant RT extend across all nodal stages (N1 to N3), with significant survival improvements noted for various primary tumor sites, indicating that RT is a crucial component of treatment for node-positive HNSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant radiotherapy and survival for patients with node-positive head and neck cancer: an analysis by primary site and nodal stage. Kao, J., Lavaf, A., Teng, MS., et al.[2019]

Citations

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

Detectable Postoperative Circulating Tumor Human Papillomavirus DNA and Association with Recurrence in Patients With HPV-Associated Oropharyngeal Squamous Cell Carcinoma. [2022]

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

From planned neck dissection to PET response to circulating tumour DNA: changes in post-treatment assessment of HPV-driven oropharyngeal cancer†. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Sinai Robotic Surgery Trial in HPV-related oropharyngeal squamous cell carcinoma (SIRS 2.0 trial) - study protocol for a phase II non-randomized non-inferiority trial. [2022]

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

Double trouble: Synchronous and metachronous primaries confound ctHPVDNA monitoring. [2023]

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

It is time to improve the diagnostic workup of oropharyngeal cancer with circulating tumor HPV DNA: Systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparing the patients' subjective experiences of acute side effects during radiotherapy for head and neck cancer with four different patient-reported outcomes questionnaires. [2019]

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

Phase I Trial of Intravenous Oncolytic Vaccinia Virus (GL-ONC1) with Cisplatin and Radiotherapy in Patients with Locoregionally Advanced Head and Neck Carcinoma. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Generalizability assessment of head and neck cancer NTCP models based on the TRIPOD criteria. [2021]

9. England pubmed.ncbi.nlm.nih.gov

GSTM1, GSTT1 and GSTP1 Ile105Val polymorphisms in outcomes of head and neck squamous cell carcinoma patients treated with cisplatin chemoradiation. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Predictors of cisplatin-induced ototoxicity and survival in chemoradiation treated head and neck cancer patients. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Radiation of jejunal interposition in T3-T4 upper aerodigestive tumours. [2019]

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

Adjuvant radiotherapy and survival for patients with node-positive head and neck cancer: an analysis by primary site and nodal stage. [2019]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Docetaxel as a component in the combined therapy of locally advanced squamous cell carcinoma of the glottis and oral cavity]. [2018]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Adjuvant Radiotherapy in Patients with Squamous Cell Carcinoma of the Oral Cavity or Oropharynx and Solitary Ipsilateral Lymph Node Metastasis (pN1)-A Prospective Multicentric Cohort Study. [2023]

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

Preoperative radiation in the treatment of cancer. [2018]