Proton Beam Therapy vs. IMRT for Esophageal Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled cardiac, others

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: 13

Duration: 5.5 weeks

147 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer. PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.

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

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

What data supports the effectiveness of the treatment Proton Beam Therapy vs. IMRT for Esophageal Cancer?

Research suggests that Proton Beam Therapy (PBT) may offer advantages over Intensity Modulated Radiation Therapy (IMRT) for esophageal cancer, potentially leading to better outcomes and fewer side effects, although more studies are needed to confirm these benefits. ^{1 2 3 4 5}

Is proton beam therapy safe for treating esophageal cancer?

Proton beam therapy (PBT) is generally considered safe for treating esophageal cancer, as it reduces radiation exposure to nearby organs like the heart and lungs, potentially lowering the risk of side effects compared to traditional methods. Studies have shown that PBT may lead to fewer acute toxicities (immediate side effects) than intensity-modulated radiation therapy (IMRT). ^{1 2 3 6 7}

How is Proton Beam Therapy different from other treatments for esophageal cancer?

Proton Beam Therapy (PBT) is unique because it can reduce radiation exposure to healthy tissues, like the heart and lungs, more effectively than Intensity Modulated Radiation Therapy (IMRT), potentially leading to fewer side effects for esophageal cancer patients. ^{1 3 4 5 8}

Research Team

Steven H. Lin, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults over 18 with esophageal cancer, who can communicate in English and have a performance status indicating they are able to carry out some activity. They must not be pregnant or breastfeeding, should agree to use contraception, and cannot have active stage 4 cancers or uncontrolled major diseases. Prior treatments like chemotherapy are allowed if there's little overlap with the new treatment area.

Inclusion Criteria

I had a procedure to remove cancer from my esophagus and it was stage II-III.

Able to communicate in the English language

I can care for myself but may not be able to do active work.

Exclusion Criteria

I do not have any major uncontrolled health issues like heart failure or recent heart attack.

I have another cancer, but treating my esophageal cancer is the priority.

I have had radiation without chemo or chemo alone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments including blood tests, performance status, imaging, lung function tests, and questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive radiation therapy (PBT or IMRT) 5 days a week for up to 28 treatments, possibly with concurrent chemotherapy

5.5 weeks

5 visits per week (in-person)

Initial Follow-up

4-6 week break with bi-weekly contact for symptom and quality of life questionnaires

4-6 weeks

2 contacts per week (virtual)

Post-Treatment Follow-up

Comprehensive assessments including medical history, physical exam, imaging, and questionnaires

4-6 weeks after treatment

1 visit (in-person)

Long-term Follow-up

Routine follow-up visits every 3-4 months for 2 years, then every 4-6 months for 3 years, including assessments and imaging

5 years

Every 3-4 months for 2 years, then every 4-6 months

Treatment Details

Interventions

• Intensity Modulated Radiation Therapy (IMRT)
• Proton Beam Therapy (PBT)
• Questionnaires

Trial Overview The trial is testing the safety and effectiveness of Proton Beam Therapy (PBT) versus Intensity-Modulated Radiation Therapy (IMRT), both combined with chemotherapy. PBT is newer and may reduce radiation damage to surrounding tissue compared to IMRT; this study aims to confirm that.

Participant Groups

Group I: Proton Beam Therapy (PBT) Experimental Treatment 2 Interventions

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).

Group II: Intensity Modulated Radiation Therapy (IMRT) Active Control 2 Interventions

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 343 esophageal cancer patients treated with definitive chemoradiotherapy, proton beam therapy (PBT) showed significantly better overall survival and progression-free survival compared to intensity-modulated radiation therapy (IMRT).

PBT was particularly beneficial for patients with stage III disease, demonstrating a 5-year overall survival rate of 34.6% compared to 25.0% for IMRT, while no significant differences were found for patients with earlier stages of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Outcomes After Definitive Chemoradiotherapy Using Proton Beam Therapy Versus Intensity Modulated Radiation Therapy for Esophageal Cancer: A Retrospective, Single-Institutional Analysis. Xi, M., Xu, C., Liao, Z., et al.[2018]

In a randomized trial involving 145 patients with locally advanced esophageal cancer, proton beam therapy (PBT) significantly reduced the total toxicity burden (TTB) compared to intensity-modulated radiation therapy (IMRT), with TTB being 2.3 times higher for IMRT.

Despite the reduced toxicity with PBT, the progression-free survival (PFS) and overall survival rates were similar between the two treatment modalities, indicating that PBT offers a safer option without compromising treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. Lin, SH., Hobbs, BP., Verma, V., et al.[2021]

Proton beam therapy (PBT) significantly reduced radiation exposure to the lungs and heart compared to photon-based radiotherapy in a study of 31 patients with locally advanced esophageal squamous cell carcinoma (ESCC).

Despite the dosimetric advantages of PBT, there were no significant differences in short-term postoperative outcomes or overall and disease-free survival rates between the PBT and photon groups after a median follow-up of 17 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Analysis of Photon versus Proton Beam Therapy in Neoadjuvant Concurrent Chemoradiotherapy for Intrathoracic Squamous Cell Carcinoma of the Esophagus at a Single Institute. Choi, JH., Lee, JM., Kim, MS., et al.[2022]

Proton beam therapy (PBT) combined with concurrent chemotherapy (CChT) shows promising results in treating esophageal cancer, with a pathologic complete response rate of 28% in surgical patients and a near complete response rate of 50%.

While the treatment is associated with some acute toxicities, such as esophagitis and fatigue, the overall clinical outcomes are encouraging, suggesting that PBT/CChT may be a viable option for managing thoracic malignancies, warranting further comparison with traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy and concurrent chemotherapy for esophageal cancer. Lin, SH., Komaki, R., Liao, Z., et al.[2022]

Intensity modulated proton beam therapy (IMPT) shows a clinically significant dosimetric advantage over intensity modulated photon therapy (IMRT) for esophageal cancer, particularly in sparing the heart and lungs, but both treatments resulted in similar acute toxicities and short-term clinical outcomes.

In a study of 64 patients, IMPT demonstrated comparable local control, progression-free survival, and overall survival rates to IMRT, indicating that IMPT is a safe and effective option for treating esophageal cancer, although longer follow-up is needed to fully assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Toxicities and Short-Term Patient Outcomes After Intensity-Modulated Proton Beam Radiation Therapy or Intensity-Modulated Photon Radiation Therapy for Esophageal Carcinoma: A Mayo Clinic Experience. Bhangoo, RS., DeWees, TA., Yu, NY., et al.[2022]

References

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

Comparative Outcomes After Definitive Chemoradiotherapy Using Proton Beam Therapy Versus Intensity Modulated Radiation Therapy for Esophageal Cancer: A Retrospective, Single-Institutional Analysis. [2018]

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

Hyperfractionated concomitant boost proton beam therapy for esophageal carcinoma. [2019]

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

Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Comparative Analysis of Photon versus Proton Beam Therapy in Neoadjuvant Concurrent Chemoradiotherapy for Intrathoracic Squamous Cell Carcinoma of the Esophagus at a Single Institute. [2022]

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

Proton beam therapy and concurrent chemotherapy for esophageal cancer. [2022]

6. China pubmed.ncbi.nlm.nih.gov

The emerging role of proton therapy for esophagus cancer. [2023]

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

Acute Toxicities and Short-Term Patient Outcomes After Intensity-Modulated Proton Beam Radiation Therapy or Intensity-Modulated Photon Radiation Therapy for Esophageal Carcinoma: A Mayo Clinic Experience. [2022]

8. China pubmed.ncbi.nlm.nih.gov

Proton beam therapy for the treatment of esophageal cancer. [2022]