The Role of Postoperative Cycles in the Perioperative Chemotherapy for Gastric Cancer

NCT01787539 | Unknown Phase 2 DMC

• 2 other identifiers: GC-COMB-0254/275/2012-MULGC-0254/282/2011/275/2012-MUL
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.

Conditions

Gastric Cancer

Keywords

gastric cancer; perioperative chemotherapy; combined modality therapy; gastrectomy

Outcome Measures

Primary Outcomes (1)

• cancer free and overall survival

  5 years

Secondary Outcomes (4)

• overall and severe toxicity rate

  8 weeks

• chemotherapy related mortality

  8 weeks

• the rate of dose reduction for chemotherapeutics

  3 months

• the rate of chemotherapy cessation

  3 months

Other Outcomes (1)

• quality of life

  1 year

Study Arms (2)

Complete Perioperative Chemotherapy

EXPERIMENTAL

Preoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Surgery: total or subtotal gastrectomy with D2 lymph node dissection. The surgical resection will be conducted 4-6 weeks after preoperative chemotherapy. Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery with the same regimen as in the preoperative part.

Drug: Postoperative Chemotherapy

Preoperative Chemotherapy

NO INTERVENTION

Preoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Surgery: total or subtotal gastrectomy with D2 lymph node dissection. The surgical resection will be conducted 4-6 weeks after preoperative chemotherapy. Patients with tumor regression grade 0, 1, 2 randomized to preoperative chemotherapy will not undergo postoperative chemotherapy and will be followed-up.

Interventions

Postoperative Chemotherapy DRUG

Postoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery.

Complete Perioperative Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead
• St Johns' Oncology Center in Lublin: collaborator

Study Sites (2)

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

Lublin, Lublin Voivodeship, 20-081, Poland

RECRUITING

St. John's Cancer Center

Lublin, Lublin Voivodeship, 20-090, Poland

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Tomasz Skoczylas, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Grzegorz Wallner, Professor

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

  PRINCIPAL INVESTIGATOR

• Elżbieta Starosławska, MD, PhD

  St Johns' Oncology Center in Lublin

  PRINCIPAL INVESTIGATOR

• Tomasz Kubiatowski, MD, PhD

  St Johns' Oncology Center in Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Skoczylas, MD, PhD

CONTACT

+48 81 5328810; tomskocz@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2022
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

PL (2)