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

September 21, 2022 updated by: Shengguang Zhao, Ruijin Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: treatment group
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

Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)
Time Frame: up to 3 months
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)
Time Frame: up to 1 year
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2019

Primary Completion (ANTICIPATED)

April 30, 2024

Study Completion (ANTICIPATED)

April 30, 2024

Study Registration Dates

First Submitted

June 16, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (ACTUAL)

June 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH2019-69

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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