RecruitingPhase 1Phase 2NCT04278287

Chemoradiotherapy in Unresectable Esophageal Cancer

A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

105 participants

Start Date

Oct 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is for patients with esophageal squamous cell cancer (a cancer of the food pipe) that cannot be removed by surgery. It studies the best way to combine chemotherapy and radiation therapy to treat the disease and extend survival. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with unresectable esophageal squamous cell cancer at certain stages - Your cancer is being treated at a specific cancer hospital in China - You are in good enough physical condition (ECOG score 0-1) - Your blood and organ functions are adequate **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond the chest lymph nodes - You are malnourished (NRS score of 3 or higher) - Your expected survival is less than 3 months - Your blood counts or organ function are too low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.

DRUGAlbumin-Bound Paclitaxel

100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.

DRUGCisplatin

25mg/m2 weekly,by intravenous infusion in 5-6 weeks.


Locations(5)

Department 4th of Radiation Oncology, Anyang Cancer Hospital

Anyang, Henan, China

Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, China

Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, China

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NCT04278287


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