Radiation Therapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jack Phan, MD,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled cardiac, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.

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. Please consult with the trial coordinators for more details.

What data supports the effectiveness of this treatment for head and neck cancer?

Research shows that intensity-modulated radiation therapy (IMRT) and its advanced form, intensity modulated proton therapy (IMPT), are effective for head and neck cancers by precisely targeting tumors while sparing nearby healthy tissues like salivary glands, reducing side effects such as feeding tube dependency. ^{1 2 3 4 5}

Is radiation therapy for head and neck cancer generally safe for humans?

Radiation therapies like Intensity-Modulated Radiation Therapy (IMRT) and Proton Radiation Therapy have been shown to reduce side effects compared to traditional methods by better targeting the tumor and sparing healthy tissues. Studies indicate that these therapies can lower the risk of acute and long-term toxicities, such as damage to salivary glands, which helps preserve functions like salivation and swallowing. ^{5 6 7 8 9}

How is the radiation therapy treatment for head and neck cancer unique?

This treatment uses advanced techniques like Intensity-Modulated Radiation Therapy (IMRT) and Intensity-Modulated Proton Therapy (IMPT) to precisely target tumors while minimizing damage to nearby healthy tissues, reducing side effects like feeding tube dependency. Proton therapy, in particular, offers superior dose localization, making it potentially more effective and safer than traditional photon-based radiation. ^{2 8 10 11 12}

Research Team

Jack Phan, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with head and neck cancer that has returned after treatment. They should be in a condition to undergo radiation (ECOG score 0-2), not pregnant, and have had previous radiation of at least 30 Gy. Candidates must not be suitable for surgery, have visible tumors on scans, and limited sites of recurrence.

Inclusion Criteria

I have had head and neck cancer before, received radiation, and it has come back or I have a new one.

I cannot have surgery for my cancer's return due to high risks.

My cancer has returned in 1-3 places, each smaller than 60 cc and all together under 100 cc.

Exclusion Criteria

Patients who are pregnant or breast feeding

My cancer has spread widely in my body.

I have heart problems like heart failure, chest pain, or irregular heartbeat not managed by a pacemaker.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either SBRT every other day for a total of 5 treatments or IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up at 2-3 months, every 3 months for 1 year, then every 3-4 months for up to 2 years

Treatment Details

Interventions

• Intensity-Modulated Radiation Therapy (Radiation Therapy)
• Proton Radiation (Radiation Therapy)
• Stereotactic Body Radiation Therapy (Radiation Therapy)

Trial Overview The study compares two advanced types of radiation therapy: Stereotactic Body Radiation Therapy (SBRT) which targets tumors precisely with fewer sessions, and Intensity Modulated Radiation/Proton Therapy (IMRT/PRT) which uses high-energy rays or protons to kill tumor cells.

Participant Groups

Group I: Group II (IMRT/IMPT) Experimental Treatment 2 Interventions

Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

Group II: Group I (SBRT) Experimental Treatment 1 Intervention

Patients undergo SBRT every other day for a total of 5 treatments.

Intensity-Modulated Radiation Therapy is already approved in Canada for the following indications:

Approved in Canada as IMRT for:

• Oropharyngeal cancer
• Head and neck cancers
• Prostate cancer
• Breast cancer
• Lung cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a study of 20 patients with locally advanced head and neck cancers, SIB-IMRT was found to be a safe treatment option, with 65% experiencing Grade III mucositis but no cases of Grade III dermatitis.

The treatment showed promising efficacy, with a projected 2-year overall survival rate of 95%, indicating strong tumor control and the potential for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of SIB-IMRT in head and neck cancers: report from a regional cancer center in northern India. Chakraborty, S., Ghoshal, S., Patil, VM., et al.[2009]

Intensity modulated proton therapy (IMPT) shows significant dosimetric advantages over traditional intensity modulated radiation therapy (IMRT) for head and neck cancers, particularly in sparing nearby organs like the larynx and salivary glands.

Clinical evidence suggests that IMPT can reduce treatment-related toxicities, such as the need for feeding tubes, indicating its potential benefits in improving patient quality of life during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity modulated proton therapy (IMPT) - The future of IMRT for head and neck cancer. Moreno, AC., Frank, SJ., Garden, AS., et al.[2020]

A study of 106 patients with head and neck squamous cell carcinoma (HNSCC) showed that simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) is effective, achieving 3-year loco-regional control rates of 78% for postoperative patients and 64% for those receiving definitive treatment.

Despite some acute and late toxicities, including dysphagia and xerostomia, SIB IMRT was found to be safe, allowing for different dose levels to be delivered within a single treatment session without increasing overall toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome and toxicity after simultaneous integrated boost IMRT in head and neck squamous cell cancer patients. Dragan, T., Beauvois, S., Moreau, M., et al.[2020]

A meta-analysis of 7 studies with 1049 head and neck cancer patients found that simultaneous integrated boost (SIB)-IMRT and sequential boost (SEQ)-IMRT have comparable clinical outcomes in terms of overall survival, progression-free survival, and locoregional recurrence-free survival.

Both SIB-IMRT and SEQ-IMRT showed similar rates of severe acute adverse effects, suggesting that either technique can be safely used for treatment, with SIB-IMRT potentially offering more convenience due to a shorter treatment course.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of clinical outcomes between simultaneous integrated boost (SIB) versus sequential boost (SEQ) intensity modulated radiation therapy (IMRT) for head and neck cancer: A meta-analysis. Jiang, L., Zhang, Y., Yang, Z., et al.[2021]

Intensity modulated proton beam therapy (IMPT) significantly reduces the average radiation dose to tooth-bearing regions in head and neck cancer patients compared to photon-based volumetric modulated arc therapy (VMAT), indicating a safer option for preserving dental health during treatment.

In a study of 121 patients, factors such as oral cavity tumors and advanced T3-T4 tumors were identified as risk factors for receiving a cumulative radiation dose of ≥40 Gy to tooth-bearing areas, which is critical for determining the need for prophylactic dental extractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planned dose of intensity modulated proton beam therapy versus volumetric modulated arch therapy to tooth-bearing regions. Alberga, JM., Meijer, J., Raghoebar, GM., et al.[2023]

Proton radiation therapy, particularly intensity-modulated proton therapy (IMPT), offers better dose localization compared to conventional photon radiation therapy, potentially reducing damage to surrounding healthy tissues in patients with head and neck and skull base tumors.

Initial clinical experiences suggest that IMPT may lead to fewer acute and long-term toxicities, and ongoing multi-institutional trials aim to further establish its effectiveness in treating these complex tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. Chan, AW., Liebsch, NJ.[2018]

Proton therapy, particularly intensity-modulated proton therapy (IMPT), offers significant dosimetric advantages over intensity-modulated radiotherapy (IMRT) for head and neck cancers, resulting in reduced doses to critical organs and lower integral doses overall.

Clinical evidence suggests that IMPT leads to fewer toxicities, such as less weight loss and a reduced need for feeding tubes, while patient survival rates are generally comparable to those receiving IMRT, with potential survival benefits noted in specific cases like base of skull or sinonasal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proton therapy for head and neck cancers]. Blanchard, P., Frank, SJ.[2022]

In a study of 47 patients with inoperable skin cancers of the head and neck treated with intensity-modulated proton therapy (IMPT), the overall survival rate at 2 years was high at 87.2%, indicating strong efficacy of this treatment.

IMPT demonstrated a low incidence of adverse events, with no patients experiencing severe side effects (grade 3 or higher) during or shortly after treatment, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic Outcomes for Head and Neck Skin Malignancies Treated with Protons. Bridhikitti, J., Viehman, JK., Harmsen, WS., et al.[2022]

Proton therapy for head and neck cancer shows promising results by delivering a lower overall radiation dose while effectively targeting the tumor, which may lead to fewer side effects compared to conventional radiotherapy.

Despite the advantages of proton therapy, conventional radiotherapy remains a strong option due to the extensive research available, suggesting that careful planning and comparison of treatment methods are essential for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of meta-analysis approach, comparing conventional radiotherapy, and proton beam therapy treating head and neck cancer. Shaikh, F., Sodhi, SK., Kale, LM., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Preliminary results of SIB-IMRT in head and neck cancers: report from a regional cancer center in northern India. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Intensity modulated proton therapy (IMPT) - The future of IMRT for head and neck cancer. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Clinical outcome and toxicity after simultaneous integrated boost IMRT in head and neck squamous cell cancer patients. [2020]

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

A comparison of clinical outcomes between simultaneous integrated boost (SIB) versus sequential boost (SEQ) intensity modulated radiation therapy (IMRT) for head and neck cancer: A meta-analysis. [2021]

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

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

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

Intensity-modulated radiotherapy: first results with this new technology on neoplasms of the head and neck. [2004]

7. England pubmed.ncbi.nlm.nih.gov

Planned dose of intensity modulated proton beam therapy versus volumetric modulated arch therapy to tooth-bearing regions. [2023]

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

Proton radiation therapy for head and neck cancer. [2018]

9. France pubmed.ncbi.nlm.nih.gov

[Proton therapy for head and neck cancers]. [2022]

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

Intensity-modulated radiation therapy. [2022]

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

Oncologic Outcomes for Head and Neck Skin Malignancies Treated with Protons. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Implementation of meta-analysis approach, comparing conventional radiotherapy, and proton beam therapy treating head and neck cancer. [2022]