SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic Esophageal Squamous Cell Carcinoma: a Phase II Study of Single Institution

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04115618
• Other study ID #: 2017-ESCCSIB
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2019
• Source: Fudan University
• Contact: Xi Yang, Phd
• Phone: 86-17321296901
• Email: ntgeorge[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA Esophageal Squamous Cell Carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histological or cytologic diagnosis of esophageal squamous carcinoma;

2. Aged 18-75 years;

3. KPS = 70;

4. Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;

5. Stage I-IVA(AJCC 6th,2009);

6. Not able to be surgically resection or rejected;

7. Not have received any prior anticancer therapy;

8. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=4x109/L, Neutrophils (ANC )=1.5x10^9/L, platelet count =100x 10^9/L, serum creatinine<1.5 mg/dL,urea nitrogen <8 mmol/L;

9. No history of malignancy;

10. No perforation of esophagus, no deep ulcer of esophagus;

11. Joined the study voluntarily and signed informed consent form.

Exclusion Criteria:

1. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;

2. Patient who has metastasis such as lung, liver metastasis;

3. Other malignant tumors;

4. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;

5. Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;

6. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;

7. Combination of pure red cell anemia or gamma globulin;

8. Allergic to any medication component studied.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• Simultaneous integrated boost intensity-modulated chemoradiotherapy
Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity Effect	Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.	8 Weeks
Secondary	PFS	Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation	One month
Secondary	OS	Time from admission to death	One month