Proton Beam Therapy for Esophageal Cancer

Not currently recruiting at 1 trial location

Overseen By Shahed Badiyan, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Other cancers, Heart failure, Angina, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares proton beam therapy with standard photon therapy for treating esophageal cancer. It assesses whether proton therapy offers similar tumor control with fewer severe side effects. Participants fall into two groups: those eligible for surgery and those who are not. Eligible participants should have stage II or III esophageal cancer and have undergone or will undergo chemotherapy. This trial suits individuals with documented esophageal cancer who have experienced chemotherapy, with surgery as a possibility based on their condition. As an unphased trial, it explores cutting-edge treatment options that may improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since induction chemotherapy is allowed, it might be possible to continue some treatments. Please consult with the trial coordinators for specific guidance.

What prior data suggests that proton beam therapy is safe for esophageal cancer patients?

Research shows that proton beam therapy is a safe and effective treatment for esophageal cancer. Studies have found that it might lower the risk of heart and lung issues compared to traditional radiation treatment, such as IMRT. Fewer side effects can make the treatment easier for many patients. Additionally, proton therapy often results in fewer severe side effects, making it a promising option for those considering a clinical trial for esophageal cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for esophageal cancer, which typically involve conventional radiation therapy alongside chemotherapy and possibly surgery, proton beam therapy offers a unique approach by using protons instead of X-rays. This method precisely targets tumors while sparing surrounding healthy tissue, potentially reducing side effects. Researchers are excited about proton beam therapy because it delivers a high dose of radiation directly to the cancer, which may improve outcomes and quality of life for patients with both resectable and unresectable esophageal cancer.

What evidence suggests that proton beam therapy might be an effective treatment for esophageal cancer?

This trial will evaluate proton beam therapy (PBT) for esophageal cancer in two separate arms: one for patients with resectable cancer and another for those with unresectable cancer. Studies have shown that PBT can reduce side effects compared to treatments like intensity modulated radiation therapy (IMRT). Research suggests that PBT might lower the risk of heart and lung damage during esophageal cancer treatment. One study found that PBT offers promising survival rates for patients with esophageal squamous cell carcinoma (ESCC). Another analysis showed that PBT often results in fewer harmful effects than photon therapy. Overall, PBT is considered a safe and effective option for treating esophageal cancer, particularly in reducing unwanted side effects. ^{2 3 5 6 7}

Who Is on the Research Team?

Gregory Vlacich, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with stage II or III esophageal cancer who can consent in English and have financial coverage for proton therapy. They must not be pregnant, agree to use contraception, and have normal organ function. Excluded are those with recent heart attacks, uncontrolled illnesses, or other cancers within the past 3 years.

Inclusion Criteria

AST(SGOT)/ALT(SGPT) < 3.0 x IULN

My kidney function is within the required range.

Platelets > 75,000/mcl

Exclusion Criteria

Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

I am scheduled for radiation without chemo or chemo alone.

I do not have any severe illnesses that could interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive proton beam therapy and standard of care chemotherapy

8-10 weeks

Surgery

Surgery is performed for resectable patients following chemoradiation

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Therapy

Trial Overview The study compares the effectiveness of Proton Beam Therapy against Intensity Modulated Radiation Therapy (IMRT) in treating esophageal cancer. It aims to see if there's a difference in severe toxicities between these treatments while tracking tumor control and patient survival.

How Is the Trial Designed?

Group I: Arm 2: Unresectable (proton beam therapy) Experimental Treatment 2 Interventions

* Proton beam therapy: total dose of 59.4 or 60 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Patient-reported outcome measures (PROs) performed at several time points

Group II: Arm 1: Resectable (proton beam therapy) Experimental Treatment 2 Interventions

* Proton beam therapy: total dose of 50 or 50.4 Gy * Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision * Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation * Patient-reported outcome measures (PROs) performed at several time points

Proton Beam Therapy is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Proton Beam Therapy for:

• Various cancers including prostate, breast, lung, liver, and head and neck cancers

Approved in European Union as Proton Therapy for:

• Various cancers including ocular melanoma, chordomas, chondrosarcomas, and certain pediatric cancers

Approved in Japan as Proton Beam Therapy for:

• Various cancers including prostate, liver, and ocular melanoma

Approved in Canada as Proton Therapy for:

• Various cancers including ocular melanoma and certain pediatric cancers

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

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]

In a study of 44 patients with clinical T1 esophageal squamous cell carcinoma (ESCC) treated with concurrent chemo-proton therapy (CCPT), 98% achieved a complete response, indicating high efficacy of this treatment approach.

The 3-year overall survival rate was 95.2%, and even among the 11% who experienced local recurrence, all were successfully treated and remained recurrence-free after a median follow-up of 23 months, highlighting the safety and effectiveness of salvage endoscopic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic results of proton beam therapy with concurrent chemotherapy for cT1 esophageal cancer and salvage endoscopic therapy for local recurrence. Sato, D., Motegi, A., Kadota, T., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9407004/

Proton Beam Therapy for Esophageal Cancer The recent studies have shown that, compared with IMRT, proton beam therapy (PBT) may be associated with additional decreases in the cardiac ...

2. mdpi.com mdpi.com/2072-6694/15/23/5524

Treatment Outcomes of Proton Beam Therapy for ... This research found that PBT showed promising results in terms of favorable overall survival rates and reducing toxicities in ESCC patients.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2808359

Efficacy and Safety in Proton Therapy and Photon ... In this meta-analysis, proton therapy was associated with reduced OARs doses and toxic effects and improved prognosis compared with photon therapy for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023002366

Proton Therapy With Concurrent Chemotherapy for ... Proton radiation therapy is a safe, effective treatment for esophageal cancer with increasing evidence supporting its role in reducing cardiopulmonary toxicity.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03482791

Proton Beam Therapy in the Treatment of Esophageal ... Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10427943/

Efficacy and Safety in Proton Therapy and Photon Therapy for ... These findings suggest that proton therapy may be more effective and safer than photon therapy for patients with esophageal cancer.

7. nrgoncology.org nrgoncology.org/GI006

NRG-GI006: Proton vs Photon for Esophageal Cancer This study is being done to determine if proton therapy can increase survival and decrease side effects compared to the usual photon radiation therapy for your ...