Clinical trial · Interventional
SIB in Upper Thoracic Esophageal Squamous Cell Carcinoma
Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic Esophageal Squamous Cell Carcinoma: a Phase II Study of Single Institution
NCT04115618CI-TRIAL-00040992unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simultaneous integrated boost intensity-modulated chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SIB
- description
- Simultaneous integrated boost intensity-modulated chemoradiotherapy
- interventionNames
- Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy
Primary outcomes (1)
- measure
- Toxicity Effect
- timeFrame
- 8 Weeks
- description
- 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 outcomes (2)
- measure
- PFS
- timeFrame
- One month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.