Back to results

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

Primary Purpose

Esophageal Cancer, Salvage Radiotherapy, Dose-escalation

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

treatment group(phase I)

treatment group (phase II)

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

Outcomes

Primary Outcome Measures

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.

Overall survival (phase II)

Survival time was measured from the date of study enrollment to the date of death or last follow-up;

Secondary Outcome Measures

Overall survival (phase I)

Survival time was measured from the date of study enrollment to the date of death or last follow-up;

Late toxicity (phase I)

late toxicity were grade according to RTOG and CTCAE criteria

Overall survival (phase II)

Survival time was measured from the date of study enrollment to the date of death or last follow-up;

acute Toxicity (phase II)

acute toxicity were grade according to CTCAE criteria

late Toxicity (phase II)

late toxicity were grade according to RTOG and CTCAE criteria

1-year local progression-free survival

From treatment initiation to first documented local progression or death or censor

Full Information

NCT ID

NCT03990532

First Posted

June 16, 2019

Last Updated

September 21, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03990532

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2019 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

treatment group(phase I)

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

treatment group (phase II)

Intervention Description

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

Primary Outcome Measure Information:

Title

Dose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)

Description

DLT was defined as grade 4 or higher hematological toxicities and/or grade 3 or higher nonhematological toxicities.

Time Frame

up to 3 months

Title

Overall survival (phase II)

Description

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

Secondary Outcome Measure Information:

Title

Overall survival (phase I)

Description

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

Title

Late toxicity (phase I)

Description

late toxicity were grade according to RTOG and CTCAE criteria

Time Frame

up to 2 year

Title

Overall survival (phase II)

Description

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

Title

acute Toxicity (phase II)

Description

acute toxicity were grade according to CTCAE criteria

Time Frame

up to 3 months

Title

late Toxicity (phase II)

Description

late toxicity were grade according to RTOG and CTCAE criteria

Time Frame

up to 2 year

Title

1-year local progression-free survival

Description

From treatment initiation to first documented local progression or death or censor

Time Frame

up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-Xiang Qi, Dr.

Phone

+86-021-64370045

qiweixiang1113@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

shengguang zhao, Dr.

Phone

+86-021-64370045

zhaoshengguang@163.com

Facility Information:

Facility Name

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei-Xiang Qi

Phone

+86-021-13761059660

qiweixiang1113@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs