Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
- Conditions
- Dose-escalationMediastinal Lymph Node RecurrenceEsophageal CancerSalvage Radiotherapy
- Interventions
- Radiation: treatment group(phase I)Radiation: treatment group (phase II)
- Registration Number
- NCT03990532
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal Cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
Histo-pathologically proven diagnosis of esophageal squamous cell carcinoma. Age ≥18 and ≤80 ECOG performance status 0-1. Clinical diagnosis of ≤5 mediastinal lymph nodes recurrence after esophagectomy.
Patients without distant metastasis and life expectancy ≥ 3 months. adequate liver and renal function and adequate bone marrow reservation. Written, signed informed consent.
Prior radiotherapy to recurrence site of esophageal cancer. Other co-existing malignancies or malignancies diagnosed within the last 5 years.
Pregnant women. Women who are breastfeeding a baby. Patients with uncontrolled serious medical or mental illnesses.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment group treatment group (phase II) - treatment group treatment group(phase I) -
- Primary Outcome Measures
Name Time Method Overall survival (phase II) up to 1 year Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB) up to 3 months DLT was defined as grade 4 or higher hematological toxicities and/or grade 3 or higher nonhematological toxicities.
- Secondary Outcome Measures
Name Time Method Overall survival (phase I) up to 1 year Survival time was measured from the date of study enrollment to the date of death or last follow-up;
late Toxicity (phase II) up to 2 year late toxicity were grade according to RTOG and CTCAE criteria
1-year local progression-free survival up to 1 year From treatment initiation to first documented local progression or death or censor
Late toxicity (phase I) up to 2 year late toxicity were grade according to RTOG and CTCAE criteria
Overall survival (phase II) up to 2 year Survival time was measured from the date of study enrollment to the date of death or last follow-up;
acute Toxicity (phase II) up to 3 months acute toxicity were grade according to CTCAE criteria
Trial Locations
- Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China