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Simultaneous integrated boost intensity-modulated chemoradiotherapy in upper thoracic esophageal squamous cell carcinoma: a phase II study of single institution

Simultaneous integrated boost intensity-modulated chemoradiotherapy in upper thoracic esophageal squamous cell carcinoma: a phase II study of single institution

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17012866
Enrollment
Unknown
Registered
2017-10-01
Start date
2014-02-01
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Experimental:Simultaneous integrated boost intensity-modulated chemoradiotherapy:Simultaneous integrated boost intensity-modulated chemoradiotherapy

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Toxicity;

Secondary

MeasureTime frame
Progression Free Survival, PFS;Overall Survival, OS;Local Failure;

Countries

China

Contacts

Public ContactZhengfei Zhu

Fudan University Shanghai Cancer Center

fuscczzf@163.com+86 18017312901

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026