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NCT00002615 · CITED IN SOURCE DOCUMENTS

Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-12-19

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically proven resectable stage II or III adenocarcinoma of the stomach * No evidence of locally inoperable or distant metastases on chest x-ray and any combination of abdominal ultrasound, CT scan, or laparoscopy PATIENT CHARACTERISTICS: Age: * Any age Performance status: * WHO 0-1 Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * No clinical evidence of uncontrolled angina pectoris, cardiac failure, or significant uncontrolled cardiac arrhythmia Other: * No medical contraindication to study therapy * No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    cisplatin
    type
    DRUG
  2. name
    epirubicin hydrochloride
    type
    DRUG
  3. name
    fluorouracil
    type
    DRUG
  4. name
    conventional surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
500
type
ESTIMATED
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer.
detailed Description
OBJECTIVES: * Compare the survival and quality of life of patients with resectable stage II or III adenocarcinoma of the stomach treated with epirubicin, cisplatin, and fluorouracil before and after resection vs resection alone. * Determine the effect of perioperative chemotherapy on the resectability of gastric cancer in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and performance status (0 vs 1). * Arm I: Patients undergo radical total gastrectomy or radical subtotal distal gastrectomy, at the discretion of the surgeon, with perigastric lymph node dissection. Patients also may undergo lymphadenectomy at the discretion of the surgeon. At the beginning of the laparotomy, a pre-aortic, infra-colic node is sampled for staging purposes and frozen sections are examined during surgery. Patients who are found to have metastatic disease undergo palliative resection at the discretion of the surgeon and postoperative chemotherapy at the discretion of the oncologist. * Arm II: Patients receive fluorouracil (5-FU) IV continuously for 3 weeks and cisplatin IV over 4 hours (beginning 4 hours after initiation of 5-FU infusion) and epirubicin IV on day 1 (ECF). Treatment continues every 3 weeks for 3 courses. Within 6 weeks after completion of course 3 and when blood counts recover, patients undergo resection as in arm I. Beginning within 4-6 weeks after surgery, patients receive 3 additional courses of ECF. Quality of life is assessed at baseline, at completion of study therapy, and then every 6 months for 2 years. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 4 years.
Source references
references
  1. citation
    Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
    pmid
    16822992
    type
    RESULT
  2. citation
    Cunningham D, Allum WH, Stenning SP, et al.: Perioperative chemotherapy in operable gastric and lower oesophageal cancer: final results of a randomised, controlled trial (the MAGIC trial, ISRCTN 93793971). [Abstract] J Clin Oncol 23 (Suppl 16): A-4001, 308s, 2005.
    type
    RESULT
  3. citation
    Allum W, Cunningham D, Weeden S: Perioperative chemotherapy in operable gastric and lower oesophageal cancer: a randomised, controlled trial (the MAGIC trial, ISRCTN 93793971). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-998, 249, 2003.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        of perioperative chemotherapy without radiation therapy.[<a href="#cit/section_4.2">2</a>] Initially, in a randomized phase III trial (<a href="/clinicaltrials/NCT00002615">MRC-ST02</a> [NCT00002615]), patients with stage II or higher adenocarcinoma of the stomach or of the lower third of the esophagus were assigned to receive th
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        py without radiation therapy.[<a href="#cit/section_4.2">2</a>] Initially, in a randomized phase III trial (<a href="/clinicaltrials/NCT00002615">MRC-ST02</a> [NCT00002615]), patients with stage II or higher adenocarcinoma of the stomach or of the lower third of the esophagus were assigned to receive three cycles of epirubicin, c
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      3. context exact
        of grade 3/4 infections, neutropenia, diarrhea, and neuropathy in the FLOT group.</li></ul></div></li><li>In the randomized phase III <a href="/clinicaltrials/NCT00002615">MAGIC</a> trial (NCT00002615), patients with stage II or higher adenocarcinoma of the stomach or of the lower third of the esophagus were assigned to receive
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      4. context exact
        ropenia, diarrhea, and neuropathy in the FLOT group.</li></ul></div></li><li>In the randomized phase III <a href="/clinicaltrials/NCT00002615">MAGIC</a> trial (NCT00002615), patients with stage II or higher adenocarcinoma of the stomach or of the lower third of the esophagus were assigned to receive three cycles of epirubicin,
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      source title
      Gastric Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 21, 2025
        datetime
        2025-02-21T12:00:00Z
        display
        February 21, 2025

    Preserved source evidence · Not medical advice