Clinical trial · Interventional
Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
NCT01670409CI-TRIAL-00055756completedPhase 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 purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.
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 Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF | Drug | — | UNRESOLVED |
| SMART | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SMART combined with PF chemotherpay
- description
- SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)
- interventionNames
- Radiation: SMART
- Drug: PF
Primary outcomes (1)
- measure
- Toxicities
- timeFrame
- The period during treatment and the 2 years after treatment
- description
- The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs as assessed by CTCAE 4.0
Secondary outcomes (3)
- measure
- Local control rate
- timeFrame
- 2 years after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * pathological proven diagnosis of primary squamous cell carcinoma of the esophagus * the primary disease located in cervical, upper or middle thoracic esophagus * no distant metastases * zubrod performance status: 0\~2 * life expectancy \> 6 months; -absence of another malignancy * adequate liver, renal and bone marrow function * women of childbearing potential and male participants must practice adequate contraception * patient must provide study-specific informed consent prior to study entry Exclusion Criteria: * evidence of tracheoesophageal or Mediastinal-esophageal fistula * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years * prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity * pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception * women who are nursing
References
Publications (2)
- DERIVEDLiu W, Zeng C, Wang S, Zhan Y, Huang R, Luo T, Peng G, Wu Y, Qiu Z, Li D, Wu F, Chen C. A combined predicting model for benign esophageal stenosis after simultaneous integrated boost in esophageal squamous cell carcinoma patients (GASTO1072). Front Oncol. 2022 Dec 22;12:1026305. doi: 10.3389/fonc.2022.1026305. eCollection 2022. PMID 37078004
- DERIVEDZhang WZ, Chen JZ, Li DR, Chen ZJ, Guo H, Zhuang TT, Li DS, Zhou MZ, Chen CZ. Simultaneous modulated accelerated radiation therapy for esophageal cancer: a feasibility study. World J Gastroenterol. 2014 Oct 14;20(38):13973-80. doi: 10.3748/wjg.v20.i38.13973. PMID 25320535