SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma

NCT ID: NCT04115618

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2021-12-01

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIB

Simultaneous integrated boost intensity-modulated chemoradiotherapy

Group Type: EXPERIMENTAL

Simultaneous integrated boost intensity-modulated chemoradiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhengfei Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xi Yang, Phd

Role: CONTACT

ntgeorge@qq.com

86-17321296901

Facility Contacts

Xi Yang, Phd

Role: primary

ntgeorge@qq.com

86-17321296901

Other Identifiers

2017-ESCCSIB

Identifier Type: -

Identifier Source: org_study_id