Proton Therapy vs Photon Radiation for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
+88 other locations
Overseen bySteven Lin
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: NRG Oncology
Must be taking: FOLFOX
Disqualifiers: Metastatic disease, Active malignancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.
Will I have to stop taking my current medications?
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 data supports the effectiveness of this treatment for esophageal cancer?
Research shows that proton therapy, particularly intensity-modulated proton therapy (IMPT), is better at protecting the heart and lungs compared to photon radiation therapy. This means it can target the cancer more precisely while reducing harm to nearby healthy tissues.
12345Is proton therapy safe for treating esophageal cancer?
Proton therapy and photon radiation therapy are both used to treat esophageal cancer, and studies suggest that proton therapy may reduce exposure to healthy tissues like the heart and lungs, potentially leading to fewer side effects. However, factors like respiratory motion can affect treatment accuracy, so careful planning is needed to ensure safety.
23567How is the treatment Proton Therapy vs Photon Radiation for Esophageal Cancer different from other treatments?
Proton therapy is unique because it can precisely target tumors while minimizing damage to nearby healthy tissues, like the heart and lungs, which is particularly beneficial for esophageal cancer. This precision reduces side effects and allows for potentially higher doses to the tumor, improving treatment outcomes compared to traditional photon radiation therapy.
23578Eligibility Criteria
This trial is for adults with stage I-IVA esophageal cancer, either adenocarcinoma or squamous cell carcinoma. They should not have metastatic disease, prior thoracic radiotherapy overlapping the treatment area, uncontrolled infections or heart conditions, and must not be pregnant. Eligible participants need a certain blood count level and organ function within normal ranges.Inclusion Criteria
I will consult a surgeon to see if I can have surgery after chemoradiation.
I had a scan after my initial chemotherapy.
Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup: History/physical examination; Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast; For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration; For patients who DID receive induction chemotherapy, scan must occur: Within 30 days after final induction chemotherapy dose; OR Within 30 days prior to Step 1 registration; Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible; Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation; Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration. Only FOLFOX will be allowed as the induction chemotherapy regimen; Zubrod performance status 0, 1, or 2; Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration); For patients who DID NOT receive induction chemotherapy: ANC >= 1,500 cells/mm^3; For patients who DID receive induction chemotherapy: ANC >= 1,000 cells/mm^3; Platelets (within 30 days prior to Step 1 registration); For patients who DID NOT receive induction chemotherapy: Platelets >= 100,000/uL; For patients who DID receive induction chemotherapy: Platelets >= 75,000/uL; Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable) (within 30 days prior to Step 1 registration); Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance > 40 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration); Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 30 days prior to Step 1 registration); Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential; The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
+22 more
Exclusion Criteria
Pregnant and/or nursing females
My esophageal cancer is located 15-18 cm from my teeth.
I do not have an active infection needing IV antibiotics.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients undergo either PBT or IMRT over 28 fractions, 5 days a week for 5.5 weeks, with concurrent chemotherapy
5.5 weeks
28 visits (in-person)
Surgery
Patients may undergo an esophagectomy within 4-8 weeks after completion of chemotherapy and radiation therapy
4-8 weeks post-treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years with follow-ups every 3-6 months, then annually
Participant Groups
The study compares proton beam radiation therapy to intensity-modulated photon radiotherapy in treating esophageal cancer. Proton therapy uses protons to target the tumor with minimal damage to surrounding tissue; photon therapy uses high-energy x-rays similarly focused.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (PBT, Chemotherapy, Esophagectomy)Experimental Treatment10 Interventions
Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU \[with capecitabine as an acceptable substitute for 5-FU\]) per institutional standards while undergoing PBT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.
Group II: Group II (IMRT, Chemotherapy, Esophagectomy)Active Control10 Interventions
Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU \[with capecitabine as an acceptable substitute for 5-FU\]) per institutional standards while undergoing IMRT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.
Intensity-Modulated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
🇪🇺 Approved in European Union as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
🇨🇦 Approved in Canada as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Geauga HospitalChardon, OH
Memorial Sloan Kettering Cancer CenterNew York, NY
University of Oklahoma Health Sciences CenterOklahoma City, OK
Mercy HospitalCoon Rapids, MN
More Trial Locations
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Who Is Running the Clinical Trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Comparative Outcomes After Definitive Chemoradiotherapy Using Proton Beam Therapy Versus Intensity Modulated Radiation Therapy for Esophageal Cancer: A Retrospective, Single-Institutional Analysis. [2018]To compare clinical outcomes between proton beam therapy (PBT) and intensity modulated radiation therapy (IMRT) in patients with esophageal cancer (EC) treated with definitive chemoradiotherapy (CRT).
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]Intensity modulated proton beam radiation therapy (IMPT) has a clinically significant dosimetric advantage over intensity modulated photon radiation therapy (IMRT) for the treatment of patients with esophageal cancer, particularly for sparing the heart and lungs. We compared acute radiation therapy-related toxicities and short-term clinical outcomes of patients with esophageal cancer who received treatment with IMPT or IMRT.
Strategies for Motion Robust Proton Therapy With Pencil Beam Scanning for Esophageal Cancer. [2021]Proton therapy of esophageal cancer is superior to photon radiation therapy in terms of normal tissue sparing. However, respiratory motion and anatomical changes may compromise target dose coverage owing to density changes, geometric misses, and interplay effects. Here we investigate the combined effect on clinical target volume (CTV) coverage and compare proton therapy with intensity modulated radiation therapy (IMRT).
Clinical outcomes of intensity modulated proton therapy and concurrent chemotherapy in esophageal carcinoma: a single institutional experience. [2022]Intensity-modulated proton therapy (IMPT) is an emerging advanced radiation technique. Although dosimetric studies demonstrate the superiority of IMPT for improving target conformity and reducing unnecessary dose to critical normal tissues, clinical experience is limited. We aim to describe our preliminary experience implementing IMPT concurrently with chemotherapy in esophageal carcinoma (EC).
Comparison of intensity modulated proton therapy beam configurations for treating thoracic esophageal cancer. [2022]Specific proton-beam configurations are needed to spare organs at risk (OARs), including lungs, heart, and spinal cord, when treating esophageal squamous cell carcinoma (ESCC) in the thoracic region. This study aimed to propose new intensity-modulated proton therapy (IMPT) beam configurations and to demonstrate the benefit of IMPT compared with intensity-modulated x-ray therapy (IMXT) for treating ESCC.
Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. [2021]Whether dosimetric advantages of proton beam therapy (PBT) translate to improved clinical outcomes compared with intensity-modulated radiation therapy (IMRT) remains unclear. This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these modalities for esophageal cancer.
Intensity-modulated proton therapy further reduces normal tissue exposure during definitive therapy for locally advanced distal esophageal tumors: a dosimetric study. [2023]We have previously found that ≤ 75% of treatment failures after chemoradiotherapy for unresectable esophageal cancer appear within the gross tumor volume and that intensity-modulated (photon) radiotherapy (IMRT) might allow dose escalation to the tumor without increasing normal tissue toxicity. Proton therapy might allow additional dose escalation, with even lower normal tissue toxicity. In the present study, we compared the dosimetric parameters for photon IMRT with that for intensity-modulated proton therapy (IMPT) for unresectable, locally advanced, distal esophageal cancer.
[The role of proton therapy in esophageal cancer]. [2022]Because of the physical properties of proton beam radiation therapy (PT), which allows energy to be deposited at a specific depth with a rapid energy fall-off beyond that depth, PT has several theoretical advantages over photon radiation therapy for esophageal cancer (EC). Protons have the potential to reduce the dose to healthy tissue and to more safely allow treatment of tumors near critical organs, dose escalation, trimodal treatment, and re-irradiation. In recent years, larger multicenter retrospective studies have been published showing excellent survival rates, lower than expected toxicities and even better outcomes with PT than with photon radiotherapy even using IMRT or VMAT techniques. Although PT was associated with reduced toxicities, postoperative complications, and hospital stays compared to photon radiation therapy, these studies all had inherent biases in relation with patient selection for PT. These observations were recently confirmed by a randomized phase II study in locally advanced EC that showed significantly reduced toxicities with protons compared with IMRT. Currently, two randomized phase III trials (NRG-GI006 in the US and PROTECT in Europe) are being conducted to confirm whether protons could become the standard of care in locally advanced and resectable esophageal cancers.