To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.

NCT ID: NCT03001726

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2023-12-31

Brief Summary

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Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Detailed Description

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Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastrectomy plus chemotherapy

In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Gastrectomy

Intervention Type PROCEDURE

In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

oxaliplatin

Intervention Type DRUG

oxaliplatin 100 mg/m2

S1

Intervention Type DRUG

S1 40mg/m2

Docetaxel

Intervention Type DRUG

docetaxel 40 mg/m2

chemotherapy alone

Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.

oxaliplatin

Intervention Type DRUG

oxaliplatin 100 mg/m2

S1

Intervention Type DRUG

S1 40mg/m2

Docetaxel

Intervention Type DRUG

docetaxel 40 mg/m2

Interventions

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Gastrectomy

In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Intervention Type PROCEDURE

oxaliplatin

oxaliplatin 100 mg/m2

Intervention Type DRUG

S1

S1 40mg/m2

Intervention Type DRUG

Docetaxel

docetaxel 40 mg/m2

Intervention Type DRUG

Other Intervention Names

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Eloxatin tegafur Taxotere

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of gastric cancer with a single non-curable factor
* A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.

Exclusion Criteria

* Patients who can have radical resection.
* Patietns who have more than one metastasis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tianshu Liu

Chairman for the department of oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tianshu Liu, Physician

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hopital

Locations

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Zhongshan hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Cui Y, Yu Y, Zheng S, Ying J, Du Y, Wang Y, Wang X, Shen Z, Liu F, Lv M, Sun Y, Liu T. Does resection after neoadjuvant chemotherapy of docetaxel, oxaliplatin, and S-1 (DOS regimen) benefit for gastric cancer patients with single non-curable factor? a multicenter, prospective cohort study (Neo-REGATTA). BMC Cancer. 2023 Apr 4;23(1):308. doi: 10.1186/s12885-023-10773-x.

Reference Type DERIVED
PMID: 37016303 (View on PubMed)

Other Identifiers

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NEO-REGATTA

Identifier Type: -

Identifier Source: org_study_id

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