Perioperative Chemotherapy in Gastric Cancer

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2023-02-01

Brief Summary

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Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.

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Detailed Description

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328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Perioperative XELOX chemotherapy

Oxaliplatin 130 mg/m2, d1 Capecitabine 1000 mg/m² two times per day (BID), d1-14, every 3 weeks (q3w) 4 cycles (12 weeks) pre-OP and 3 cycles (12 weeks) post-OP

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

1000 mg/m² two times per day (BID), d1-14

Oxaliplatin

Intervention Type DRUG

130 mg/m² d1 i.v. every 3 weeks

Perioperative FLOT chemotherapy

Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

50mg/m2, d1, i.v., every 2 weeks

Oxaliplatin

Intervention Type DRUG

85 mg/m², d1, i.v., every 2 weeks

Leucovorin

Intervention Type DRUG

200 mg/m², d1, i.v., every 2 weeks

Fluorouracil

Intervention Type DRUG

2600 mg/m²d1 i.v. every 2 weeks

Interventions

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Docetaxel

50mg/m2, d1, i.v., every 2 weeks

Intervention Type DRUG

Oxaliplatin

85 mg/m², d1, i.v., every 2 weeks

Intervention Type DRUG

Leucovorin

200 mg/m², d1, i.v., every 2 weeks

Intervention Type DRUG

Fluorouracil

2600 mg/m²d1 i.v. every 2 weeks

Intervention Type DRUG

Capecitabine

1000 mg/m² two times per day (BID), d1-14

Intervention Type DRUG

Oxaliplatin

130 mg/m² d1 i.v. every 3 weeks

Intervention Type DRUG

Other Intervention Names

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oxaliplatine

Eligibility Criteria

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Inclusion Criteria

* cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
* cN0-3
* M0
* Age: 18 - 80
* ECOG: 0 - 1
* Histological type: adenocarcinoma
* Differentiation grade: G0 - G4
* No previous surgery
* No previous chemotherapy
* No concomitant severe comorbidity
* Written informed consent

Exclusion Criteria

* cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
* Presense of distant metastases
* ECOG: 2 - 5
* Age: \<18 and \>80
* Severe concomitant comorbidity

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No