NCT04278287RecruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 18 Feb 2020
- Start date
- 1 Oct 2019
- Primary completion date
- Dec 2025
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04278287
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 105
- From 1 Oct 2019 to the primary completion date, Dec 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Existing active infection such as active tuberculosis and hepatitis
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
Lab values
- History of allergic reactions attributed to paclitaxel, albumin or cisplatin
Other
- With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc
- Participation in other clinical trials currently or within 4 weeks of selection
- Pregnant or lactating females
Who the study is looking for
- 18\~75 years
- Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)
- Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
- ECOG PS score: 0\~1
- NRS2002 score \<3
- Estimated survival time ≥3 months
- Normal organ and marrow function as defined below:
- Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit
- Informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department 4th of Radiation Oncology, Anyang Cancer Hospital Coordinator of this site? Confirm its status | Anyang | China | Recruiting |
| 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) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.