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Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy

Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy Versus Receiving the Original Chemotherapy in Locally Advanced Gastric Cancer: a Randomized Controlled Study

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03322969
Enrollment
60
Registered
2017-10-26
Start date
2017-08-23
Completion date
2023-08-31
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Gastric Cancer

Brief summary

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.

Detailed description

For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy. Overall survival and disease-free survival will be observed between two groups.

Interventions

DRUGPaclitaxel/DDP

receiving the modified chemotherapy

DRUGXELOX/SOX

receiving the original chemotherapy

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases; * ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions; * age ≥18 years old; * no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer; * gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ; * signed the informed consent form.

Exclusion criteria

* All do not reach the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
disease free survival3 yearDFS between two arms

Countries

China

Contacts

Primary ContactXiang Wang, Doctor
wangxiang5123@126.com011-86-10-69151279
Backup ContactLin Zhao, Doctor
wz20010727@aliyun.com011-86-10-69151279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026