Clinical trial NCT03990532: Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
Official title: Phase I/II Dose Escalation by Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Salvage Radiotherapy
Dose-escalation
Mediastinal Lymph Node Recurrence
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)
timeFrame: up to 3 months
measure: Overall survival (phase II)
timeFrame: up to 1 year
Secondary outcomes:
measure: Overall survival (phase I)
timeFrame: up to 1 year
measure: Late toxicity (phase I)
timeFrame: up to 2 year
measure: Overall survival (phase II)
timeFrame: up to 2 year
measure: acute Toxicity (phase II)
timeFrame: up to 3 months
measure: late Toxicity (phase II)
timeFrame: up to 2 year
measure: 1-year local progression-free survival
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: