SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy

• Registration Number: NCT04115618
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-09-29
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIB	Simultaneous integrated boost intensity-modulated chemoradiotherapy	Simultaneous integrated boost intensity-modulated chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Toxicity Effect	8 Weeks	Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.

Secondary Outcome Measures

Name	Time	Method
PFS	One month	Time of disease progression or unrecorded time of death due to any cause from the day of admission to the first imaging confirmation
OS	One month	Time from admission to death

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China