| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Adenocarcinoma | Radiation: Adjuvant Chemoradiotherapy Drug: Adjuvant Chemotherapy | Phase 3 |
Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation.
As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 408 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma |
| Actual Study Start Date : | March 11, 2019 |
| Estimated Primary Completion Date : | February 29, 2024 |
| Estimated Study Completion Date : | May 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Adujvant CT+CRT
Four to six weeks after D2 radical surgery, adjuvant chemotherapy was initiated with SOX regimen , repeated every three weeks, and adjuvant radiotherapy was started at the end of two cycles of adjuvant chemotherapy , with synchronous tegiol single drug chemotherapy. And the original SOX regimen was continued for 4 cycles after 3-4 weeks of radiotherapy.
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Radiation: Adjuvant Chemoradiotherapy
DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
Other Name: CRT
Drug: Adjuvant Chemotherapy Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
Other Name: CT
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Active Comparator: Adujvant CT
The adjuvant chemotherapy was started 4-6 weeks after D2 radical operation. The SOX regimen was repeated every 3 weeks for 8 cycles.
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Drug: Adjuvant Chemotherapy
Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
Other Name: CT
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Luying Liu | 13957113195 | luyingliu@163.com | |
| Contact: Jinwen Shen | 13616543578 | shenjw2005@126.com |
| China, Zhejiang | |
| Jinwen Shen | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: Jinwen Shen shenjw2005@126.com | |
| Principal Investigator: | Xiangdong Cheng | Zhejiang Cancer Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 1, 2019 | ||||||||
| First Posted Date ICMJE | June 4, 2019 | ||||||||
| Last Update Posted Date | June 4, 2019 | ||||||||
| Actual Study Start Date ICMJE | March 11, 2019 | ||||||||
| Estimated Primary Completion Date | February 29, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
disease-free survival [ Time Frame: 3 year ] after primary treatment the patient survives without any signs or symptoms of cancer.
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||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma | ||||||||
| Official Title ICMJE | Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma | ||||||||
| Brief Summary | This study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard D2 radical resection. | ||||||||
| Detailed Description |
Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation. As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence. |
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| 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 | Gastric Adenocarcinoma | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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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 |
408 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 31, 2025 | ||||||||
| Estimated Primary Completion Date | February 29, 2024 (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 70 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 | NCT03973008 | ||||||||
| Other Study ID Numbers ICMJE | ZJCH-GA-CRT | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Zhejiang Cancer Hospital | ||||||||
| Study Sponsor ICMJE | Zhejiang Cancer Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Zhejiang Cancer Hospital | ||||||||
| Verification Date | May 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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