To our knowledge, this study protocol is the first to identify the sensitivity and specificity of oral meglumine diatrizoate in an esophagogram for screening esophageal fistula during radiotherapy. If oral meglumine diatrizoate can be used to screening esophageal fistula, more patients will benefit from early detection and treatment.
Introduction:
Re-irradiation after radiotherapy is a common treatment for locally recurrent esophageal cancer. However, the side effects of re-irradiation are serious. The most serious adverse reactions of re-irradiation include esophageal perforation and hemorrhage caused by esophageal perforation. Studies have shown that pulsed low-dose rate radiotherapy (PLDR) induces a hypersensitivity effect on tumor tissue and a hyper-repair effect on normal tissue, which can simultaneously reduce damage on the normal tissue and increase the therapeutic effect on the tumor. The objective of this study is to explore whether PLDR can reduce rate of esophageal perforation and improve efficacy in patients with recurrent esophageal squamous cell carcinoma (ESCC) after radiotherapy.
Methods and analysis:
This study is a prospective, multi-center, open, single-arm clinical trial designed to enroll 27 patients with locally recurrent ESCC after radiotherapy with or without chemotherapy. Re-irradiation will be performed using intensity modulated radiation therapy in 50 Gy/25 fractions. The strategy of PLDR includes dividing 2 Gy into 10 fractions, and administering each irradiating dose of 20 cGy at an interval of 3 minutes before the next low-dose irradiation. The actual dose rate of administration each time will be 16.67 cGy /minute. The primary endpoint in this study is the rate of esophageal perforation. The secondary endpoints are the objective remission rate, the palliative effect on quality of life and pain, and the time of disease progression. The observation time is 2 years after the end of the study.
Trial registration:
Clinical trial number: ChiCTR1900020609.
The efficacy of single-agent chemotherapy was not significantly different from that of double-agent chemotherapy in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma. • Single-agent concurrent chemoradiotherapy had lower gastrointestinal and hematologic toxicity. • Overall survival and progression-free survival were not significantly different between single-and double-agent concurrent chemoradiotherapy.
Background:
This study aimed to investigate the specificity and sensitivity of oral meglumine diatrizoate esophagogram in screening for esophageal fistula during radiotherapy or chemoradiotherapy for esophageal cancer and determine if early detection and intervention could improve the prognosis of esophageal fistulas.
Methods:
Esophageal cancer patients undergoing radiotherapy or chemoradiotherapy were included. Weekly oral meglumine diatrizoate esophagograms were performed to screen for esophageal fistulas during radiotherapy. When an esophageal fistula was detected, fibroesophagoscopy and computed tomography (CT) were used for confirmation; once confirmed, radiotherapy was discontinued, and the patient received intervention. The esophagogram results were reviewed weekly to assess the recovery of the esophageal fistula. If the fistula was healed, the patient resumed and completed radiotherapy.
Results:
A total of 206 patients with cancer of the esophagus undergoing chemotherapy/radiotherapy were included. During radiotherapy, 10 cases of esophageal fistula were detected or suspected based on the oral meglumine diatrizoate esophagography findings, and eight of those cases were confirmed by CT and esophagoscopy. All patients with esophageal fistula received intervention; among them, 62.5% (5/8) recovered after 1 to 2 weeks of treatment and continued radiotherapy to completion. The sensitivity and specificity of oral meglumine diatrizoate esophagography in screening for esophageal fistulas during radiotherapy or chemoradiotherapy were 100 and 98.9%, respectively. The median survival period of patients with esophageal fistulas was 6.4 months.
Conclusion:
Oral meglumine diatrizoate esophagography has high sensitivity and specificity in screening for esophageal fistulas during radiotherapy or chemoradiotherapy with minimal side effects. Early diagnosis and timely intervention can significantly improve the prognosis and prolong the survival period of patients.
Trial Registration:
Chictr.org.cn, Identifier: ChiCTR-DDD-17012617. Registered on September 7, 2017. The first participant was enrolled on September 25, 2017.
http://www.chictr.org.cn/showproj.aspx?proj=21526
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We developed a new method for immobilization of the fix lower extremities by using a thermoplastic mask, a carbon fiber base plate, a customized headrest, and an adjustable angle holder. The lower extremities of 11 patients with lower extremity tumors were immobilized by this method. CT simulation was performed for each patient. For all 11 patients, the device fit was suitable and comfortable and had good reproducibility, which was proven in daily radiotherapy.
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