Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Phase I/II Dose Escalation by Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990532
• Other study ID #: RJH2019-69
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2022
• Source: Ruijin Hospital
• Contact: Wei-Xiang Qi, Dr.
• Phone: +86-021-64370045
• Email: qiweixiang1113[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dose-escalation
• Esophageal Cancer
• Esophageal Neoplasms
• Mediastinal Lymph Node Recurrence
• Recurrence
• Salvage Radiotherapy

Intervention

Radiation:
• treatment group(phase I)
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
• treatment group (phase II)
Radiotherapy dose was prescribed according to phase I trial results; Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 3 months
Primary	Overall survival (phase II)	Survival time was measured from the date of study enrollment to the date of death or last follow-up;	up to 1 year
Secondary	Overall survival (phase I)	Survival time was measured from the date of study enrollment to the date of death or last follow-up;	up to 1 year
Secondary	Late toxicity (phase I)	late toxicity were grade according to RTOG and CTCAE criteria	up to 2 year
Secondary	Overall survival (phase II)	Survival time was measured from the date of study enrollment to the date of death or last follow-up;	up to 2 year
Secondary	acute Toxicity (phase II)	acute toxicity were grade according to CTCAE criteria	up to 3 months
Secondary	late Toxicity (phase II)	late toxicity were grade according to RTOG and CTCAE criteria	up to 2 year
Secondary	1-year local progression-free survival	From treatment initiation to first documented local progression or death or censor	up to 1 year