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出境医 / 临床实验 / Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Cancer Salvage Radiotherapy Dose-escalation Mediastinal Lymph Node Recurrence | Radiation: treatment group(phase I) Radiation: treatment group (phase II) | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 46 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase I/II Dose Escalation by Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer |
| Actual Study Start Date : | April 30, 2019 |
| Estimated Primary Completion Date : | April 30, 2021 |
| Estimated Study Completion Date : | April 30, 2022 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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.
- 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;
Secondary Outcome Measures :
- 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;
- Late toxicity (phase I) [ Time Frame: up to 2 year ]late toxicity were grade according to RTOG and CTCAE criteria
- 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;
- acute Toxicity (phase II) [ Time Frame: up to 3 months ]acute toxicity were grade according to CTCAE criteria
- late Toxicity (phase II) [ Time Frame: up to 2 year ]late toxicity were grade according to RTOG and CTCAE criteria
- 1-year local progression-free survival [ Time Frame: up to 1 year ]From treatment initiation to first documented local progression or death or censor
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Contacts
| Contact: Wei-Xiang Qi, Dr. | +86-021-64370045 | qiweixiang1113@163.com | |
| Contact: shengguang zhao, Dr. | +86-021-64370045 | zhaoshengguang@163.com |
Locations
| China, Shanghai | |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200040 | |
| Contact: Wei-Xiang Qi +86-021-13761059660 qiweixiang1113@163.com | |
Sponsors and Collaborators
Ruijin Hospital
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 16, 2019 | ||||||||
| First Posted Date ICMJE | June 19, 2019 | ||||||||
| Last Update Posted Date | June 19, 2019 | ||||||||
| Actual Study Start Date ICMJE | April 30, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer | ||||||||
| Official Title ICMJE | Phase I/II Dose Escalation by Simultaneous Integrated Boost for Mediastinal Lymph Node Recurrence After Radical Surgery of Esophageal Cancer | ||||||||
| 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 | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: treatment group
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
46 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 30, 2022 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03990532 | ||||||||
| Other Study ID Numbers ICMJE | RJH2019-69 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Shengguang Zhao, Ruijin Hospital | ||||||||
| Study Sponsor ICMJE | Ruijin Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Ruijin Hospital | ||||||||
| Verification Date | June 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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