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The Role of Postoperative Chemotherapy Cycles in the Combined Modality Therapy of Gastric Cancer With Perioperative Chemotherapy and Surgery in Pathological Responders

Phase 2/Phase 3
18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

The Role of Postoperative Chemotherapy Cycles in the Combined Modality Therapy of Gastric Cancer With Perioperative Chemotherapy and Surgery in Pathological Responders

The MAGIC trial, also considered the "milestone" study, definitely proved that neoadjuvant
chemotherapy improves the outcome of patients with locally advanced gastric cancer.
Resection was considered curative in 79% under combination therapy versus in 69% of only
operated patients (P = 0.02), 2-year survival rates were 50 and 41%, and 5-year-survival
rates were 36 and 23% (P = 0.009), respectively. The substantial weak point of the MAGIC
trial remains the fact that only about 40% of the patients received the full dosage of
scheduled postoperative chemotherapy, mainly due to intolerance or toxicity reasons.

The noninferiority in relation to survival of capecitabine to 5-FU in triplet regimens for
the treatment of patients with advanced esophagogastric cancer was demonstrated in the large
multicenter randomized phase III, REAL-2 study, including 1002 patients. Capecitabine has
overcome the doubts concerning the potential efficacy of oral drug administration in
patients with gastric carcinoma, especially in relation to those patients who have undergone
partial or total gastrectomy. The same study demonstrated the noninferiority of oxaliplatin
versus cisplatin in advanced gastric cancer and confirmed the acceptable tolerability
profile of this third-generation platinum analogue. It was anticipated that the use of these
newer agents as components of triplet regimens would reduce toxicity and thereby render an
alternative to the standard ECF combination easier to handle as a consequence of replacing
the cisplatin component with oxaliplatin, replacing the infusional 5-fluorouracil component
with oral capecitabine in EOX regimen. Furthermore, achieving a median overall survival time
of 11.2 months, the EOX regimen appeared to be more active than ECF (median overall survival
time, 9.9 months), with the higher 1-year survival rate 47% vs 38%, respectively. Compared
with the ECF regimen, EOX was associated with significantly lower rates of grade 3 or 4
neutropenia and grade 2 alopecia, but significantly higher rates of grade 3 or 4 lethargy,
diarrhea, and peripheral neuropathy. Based on the results of the REAL study, EOX is
therefore tolerable, and at least as active as ECF. This modified regimen could therefore be
considered to be a new standard treatment and may be an appropriate reference regimen for
future studies in advanced gastric cancer.

Inclusion Criteria:

- histopathologically confirmed gastric cancer

- potentially resectable, local or locoregional cancer with clinical staging
cT2-4aN0-3M0. A clinical assessment of location, resectability and staging will be
performed based on endoscopy, barium swallow, endoscopic ultrasound, multidetector
computed tomography and diagnostic laparoscopy with cytology washing.

- medically fit to undergo a major abdominal surgery and in general condition allowing
to tolerate long-lasting chemotherapy (Karnofsky Performance Status ≥70, ECOG 0-1)

Exclusion Criteria:

- Pregnancy or breast feeding.

- Diagnosed other malignancy and/or chemotherapy administrated within the last 5 years

- Gastric remnant cancer;

- Early Gastric Cancer;

- Irresectable or disseminated cancer with distant organ metastases and/or peritoneal
spreading and/or positive cytology washing

- Poor performance status measured by Karnofsky index < 60 or ECOG < 1

- Clinically important active systemic disease: unstable diabetes, circulatory failure
of NYHA III or IV, unstable arterial hypertension, unstable coronary heart disease,
recent heart infarct or brain insult within the last 6 months, severe COPD,
peripheral neuropathy of grade 2-4;

- Severe hematological abnormalities: HGB < 10.0 gm/dL and/or neutropenia < 1500 /mm3;
PLT < 100 000 /mm3.

- Severe renal dysfunction requiring peritoneal dialysis, hemodialysis or
hemofiltration or oliguria <20ml/h.

- Severe liver dysfunction: acute or chronic hepatitis, liver cirrhosis, liver failure,
abnormal liver testing: ALAT or ASPAT or ALP >2.5 - 5.0 × upper limit; total
bilirubin >2 x upper limit.

- Concommitant infection

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

cancer free and overall survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Tomasz Skoczylas, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin


Poland: Ethics Committee

Study ID:




Start Date:

February 2013

Completion Date:

February 2022

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • perioperative chemotherapy
  • combined modality therapy
  • gastrectomy
  • Stomach Neoplasms