An interventional study of treatment group(phase I) and treatment group (phase II) in Esophageal Cancer, Salvage Radiotherapy and Dose-escalation, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 46 is below the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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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.
Radiation: treatment group(phase I) · Radiation: treatment group (phase II)
Dose-escalation plan (phase I) Radiotherapy: LEVEL 1: dose given at PTV-G will be 58.8Gy/28 fractions； 2.1Gy/per fraction; LEVEL 2: dose given at PTV-G will be 64.4Gy/28 fractions； 2.3Gy/per fraction; LEVEL 3: dose given at PTV-G will be 70Gy/28 fractions； 2.5Gy/per fraction Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine
Radiotherapy dose was prescribed according to phase I trial results; Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine
Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)
DLT was defined as grade 4 or higher hematological toxicities and/or grade 3 or higher nonhematological toxicities.
Time frame: up to 3 months
Overall survival (phase II)
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Time frame: up to 1 year
Overall survival (phase I)
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Time frame: up to 1 year
Late toxicity (phase I)
late toxicity were grade according to RTOG and CTCAE criteria
Time frame: up to 2 year
Overall survival (phase II)
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Time frame: up to 2 year
acute Toxicity (phase II)
acute toxicity were grade according to CTCAE criteria
Time frame: up to 3 months
late Toxicity (phase II)
late toxicity were grade according to RTOG and CTCAE criteria
Time frame: up to 2 year
1-year local progression-free survival
From treatment initiation to first documented local progression or death or censor
Time frame: up to 1 year
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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