Clinical trial · Interventional
Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma
Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
NCT02384811CI-TRIAL-00029439unknownPhase 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)
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for 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 |
|---|---|---|---|
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation group
- description
- Radiation therapy
- interventionNames
- Radiation: radiation
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- 5 year
- measure
- Safety: Frequencies of treatment-related adverse event categories by NCI-CTC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Joined the study voluntarily and signed informed consent form; * Age 18-75;ECOG 0-2 * Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well. * T3-4N0M0, T1-4N1-3M0 (according to AJCC2009) * No radiotherapy, chemotherapy or other treatments pre(post)surgery * PS ECOG 0-2 * Life expectancy of more than 3 months * Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN • Renal function: creatinine \< 1.5 x ULN * No immuno-deficiency * Use of an effective contraceptive for adults to prevent pregnancy. Exclusion Criteria: * Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis * Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years * Participation in other interventional clinical trials within 30 days * Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * Drug addiction, Alcoholism or AIDS * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * Unsuitable to be enrolled in the trial in the opinion of the investigators
References
Publications (1)
- DERIVEDZhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021. PMID 34295813