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

NCT03990532 | Unknown

• 1 other identifier: RJH2019-69
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Cancer; Salvage Radiotherapy; Dose-escalation; Mediastinal Lymph Node Recurrence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Overall survival (phase I)

  up to 1 year

• Late toxicity (phase I)

  up to 2 year

• Overall survival (phase II)

  up to 2 year

• acute Toxicity (phase II)

  up to 3 months

• late Toxicity (phase II)

  up to 2 year

Study Arms (1)

treatment group

EXPERIMENTAL

Radiation: treatment group(phase I); Radiation: treatment group (phase II)

Interventions

treatment group(phase I) RADIATION

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

treatment group (phase II) RADIATION

Radiotherapy dose was prescribed according to phase I trial results; Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Wei-Xiang Qi, Dr.

CONTACT

+86-021-64370045; qiweixiang1113@163.com

shengguang zhao, Dr.

CONTACT

+86-021-64370045; zhaoshengguang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 19, 2019
• Study Start: April 30, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

CN (1)