Northfield

Researchers are evaluating how well proton beam radiation therapy compares with intensity modulated photon radiotherapy in treating patients with stage I to IVA esophageal cancer. This phase III trial aims to determine if proton beam therapy can improve overall survival and reduce serious heart and lung side effects compared to photon therapy. The study also looks at symptom impact, quality of life, treatment costs, response rates, and hospitalization length between the two treatments. Participants are randomly assigned to receive either proton beam therapy or intensity modulated photon therapy, both given in 28 sessions over 5.5 weeks alongside chemotherapy. Chemotherapy options include carboplatin/paclitaxel, FOLFOX/CAPOX, or docetaxel/fluorouracil regimens, selected by the patient and physician. After completing chemoradiation, patients may have surgery to remove the tumor if it is safe and feasible. During the study, blood samples and imaging scans such as PET/CT or CT are collected to monitor progress. Patients are followed every 3 to 6 months for three years and then yearly to track survival, side effects, and disease status. Researchers also assess patient-reported symptoms and quality of life. The main outcomes measured are overall survival and the occurrence of serious heart and lung side effects related to treatment over up to eight years. Additional assessments include immune cell levels, disease recurrence, and treatment toxicity.

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery to remove their tumors. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival, especially considering the role of p53 mutations in the cancer cells. The study also investigates toxicities and potential genomic factors that might influence treatment outcomes. Patients are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy (IMRT) alone once daily, five days a week for six weeks. The other group receives the same radiation treatment combined with weekly intravenous cisplatin over one to two hours, also for six weeks. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants undergo regular follow-ups every six months for three years and then yearly for seven more years to monitor for cancer recurrence or new tumors. Researchers assess disease-free survival, tracking the time from randomization until cancer returns, a second tumor develops, or death. Additional laboratory tests and biomarker analyses are performed to understand genetic changes and treatment effects. Safety and toxicities are closely monitored throughout the study period.