Condition or disease | Intervention/treatment | Phase |
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Esophageal Squamous Cell Carcinoma | Combination Product: adjuvant treatment | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 819 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma |
Actual Study Start Date : | August 23, 2019 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | July 1, 2027 |
Arm | Intervention/treatment |
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Experimental: Chemotherapy
Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
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Combination Product: adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
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Experimental: Chemoradiotherapy
5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
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Combination Product: adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
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No Intervention: Surgery alone
Surgery alone, no adjuvant treatment.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bin Zheng, MD | +8659186218408 ext 8408 | lacustrian@163.com |
China, Fujian | |
Fujian Medical University Union Hospital | Recruiting |
Fuzhou, Fujian, China, 350001 | |
Contact: Bin Zheng, MD +8659186218408 |
Study Director: | Chun Chen, MD | Fujian Medical University Union Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | July 1, 2019 | ||||
First Posted Date ICMJE | July 5, 2019 | ||||
Last Update Posted Date | September 6, 2019 | ||||
Actual Study Start Date ICMJE | August 23, 2019 | ||||
Estimated Primary Completion Date | July 1, 2022 (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 | |||||
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 | Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma | ||||
Official Title ICMJE | Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma | ||||
Brief Summary | A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer. | ||||
Detailed Description | A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Esophageal Squamous Cell Carcinoma | ||||
Intervention ICMJE | Combination Product: adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* 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 |
819 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 1, 2027 | ||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 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 | NCT04009265 | ||||
Other Study ID Numbers ICMJE | ACRTEC UNION | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Fujian Medical University Union Hospital | ||||
Study Sponsor ICMJE | Fujian Medical University Union Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Fujian Medical University Union Hospital | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |