Proton therapy for treating esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility, toxicity, and efficacy of a treatment regimen that combines proton therapy with a systemic chemotherapy regimen of carboplatin and paclitaxel, followed by definitive surgery. The aim is to improve upon traditional chemotherapy regimens by using carboplatin to reduce toxicity and adding paclitaxel, which enhances the effectiveness of radiation. The study focuses on patients with localized esophageal cancer, specifically targeting those with squamous cell or adenocarcinoma types. The treatment approach is designed to optimize dose distribution patterns using proton beam therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus that involves the mid, distal or esophagogastric junction. The cancer may involve the stomach up to 5 cm.
* Endoscopy with biopsy
* Stage T1N102, T2-3N0-2 according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based upon the following minimum diagnostic work-up:

History/physical examination with documentation of patient's weight within 30 days of registration

Chest/Abdominal/Pelvic contrast CT within 56 days of registration

Whole body PET/CT within 56 days of registration

Endoscopic ultrasound

Patients may have regional adenopathy including para-esophageal, gastric, gastroheptaic and celiac nodes. If celiac adenopathy present, it must be ≤ 2cm.

Patients with tumors at the level of the carina or above should undergo bronchoscopy to exclude fistula

Pulmonary function test (including routine spirometry and DLCO) within 60 days prior to registration

Serum creatinine ≤ 2 x the upper limit of normal within 4 weeks of registration

Na, K, BUN, Glucose within 4 weeks prior to registration

CBC/differential within 4 weeks prior to registration with adequate bone marrow function, defined as follows:

* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelets ≥ 100,000 cell/mm3
* Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)

Adequate liver function, defined as total bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x the upper limit of normal within 4 weeks of registration

Age ≥ 18

Zubrod performance status 0-2 within 4 weeks of registration

Surgical consultation to confirm that patient will be able to undergo curative resection after completion of PCT prior to registration

For women of childbearing potential, a negative serum pregnancy test within 14 days prior to registration

Women of childbearing potential and male participants must practice adequate contraception while on study

Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

Patients with cervical esophageal carcinoma

Patients with T1N0 disease and T4 disease

Prior radiation for esophageal cancer or prior chest radiotherapy

Prior chemotherapy for esophageal cancer

Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi

Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years ( e.g. carcinoma in situ of breast, oral cavity, or cervix are permissible)

Prior radiotherapy that would results in overlap of radiation fields

Medical contraindications to esophagectomy

Prior allergic reaction to paclitaxel or carboplatin

Severe, active co-morbidity that may impact survival

Pregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception

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Where it's running

• Loma Linda University Medical Center
  Loma Linda, California, United States Recruiting

Study contacts

• Principal investigator: Gary Yang, MD — gyang@llu.edu
• Study coordinator: Proton Referral Office First call: Referral Office intake personnel
• Phone: 909-558-4288 or 1 800 PROTONS

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized Ultrafractionated Stereotactic Radiotherapy with Perioperative FLOT for GEJ and Esophageal Cancer

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  Recruiting Phase 1 University of Texas Southwestern Medical Center · Dallas, Texas · NCT07700420

• Preventing nausea and vomiting during multi-cycle chemo and immunotherapy in esophageal and lung cancer

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  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07617246

• Ivonescimab plus FOLFOX for advanced HER2-negative stomach and gastroesophageal junction adenocarcinoma

  This study tests whether adding ivonescimab to standard FOLFOX chemotherapy helps people with advanced, HER2-negative stomach or gastroesophageal junction adenocarcinoma as first-line treatment.

  Recruiting at 2 sites Phase 2 Massachusetts General Hospital · Santa Monica, California and 1 other locations · NCT07070466

• AI prediction of response to pre-surgery chemoimmunotherapy for esophageal cancer

  This project tests whether combining clinical records, CT scans, pathology, and lab results with deep learning can predict which patients with locally advanced esophageal cancer will respond to neoadjuvant chemoimmunotherapy before surgery.

  Recruiting Central South University · Changsha, Hunan · NCT07063901

• 18F-G1 PET/CT to see early immunotherapy response in solid tumors and blood cancers

  We are testing if the 18F-G1 PET/CT scan can help tell early on whether people with solid tumors or blood cancers will respond to immunotherapy.

  Recruiting Peking University First Hospital · Beijing · NCT07039474

• Combining afatinib and palbociclib for previously treated advanced esophageal squamous cell carcinoma

  This trial tests whether taking afatinib together with palbociclib helps control tumor growth in people with recurrent or metastatic esophageal squamous cell carcinoma who have already received prior treatments.

  Recruiting Phase 1/2 West China Hospital · Chengdu, Sichuan · NCT06753747

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.