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NCT01197118 · CITED IN SOURCE DOCUMENTS

Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

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

Phase
PHASE2
Status at capture
UNKNOWN
Registry last update
2010-09-09

Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains poor despite potentially curative resections. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, even after a complete resection with negative margins, many patients will experience recurrence. In recent years, the radiation therapy in the carcinoma of the stomach represents a new issue that should be addressed accompanying the development of radial physics and radial biology, the clinical application of computed tomographic (CT) simulation and digital reconstitution technique, especially the application of 3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to cause a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival for advanced gastric 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
Inclusion Criteria: 1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction. 2. Age of 18 to 75, Karnofsky score higher than 70. 3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, with or without positive incisal margin. 4. No severe functional damage of major organ, normal blood cell, normal liver and kidney function. 5. No clinical findings of distant metastasis. 6. Predictive survival time longer than 6 months.
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    chemotherapy alone following radical resection
    intervention Names
    1. Drug: chemotherapy alone following radical resection
    label
    2
    type
    ACTIVE_COMPARATOR
  2. description
    sequence chemoradiotherapy following radical resection
    intervention Names
    1. Radiation: sequence chemoradiotherapy
    label
    1
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. 1
    description
    Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 15MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered. Postoperative chemotherapy regimen: see arm 2
    name
    sequence chemoradiotherapy
    type
    RADIATION
  2. arm Group Labels
    1. 2
    description
    Postoperative chemotherapy regimen: The OLF regimen was administrated: Oxaliplatin, 130 mg/m2/day on day1, i.v. 2 h; fluorouracil, 425 mg/m2/day on day1\~5, i.v.; leucovorin, 200 mg/m2/day on day 1\~5, i.v.; every 21 days repeated, for 6 cycles.
    name
    chemotherapy alone following radical resection
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
40
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    overall survival
    time Frame
    1 year
Full study description
brief Summary
Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains poor despite potentially curative resections. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, even after a complete resection with negative margins, many patients will experience recurrence. In recent years, the radiation therapy in the carcinoma of the stomach represents a new issue that should be addressed accompanying the development of radial physics and radial biology, the clinical application of computed tomographic (CT) simulation and digital reconstitution technique, especially the application of 3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to cause a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival for advanced gastric cancer.
Source references
references
  1. citation
    Xiang-Lin Yuan, Qiang Fu ,Shi-Ying Yu .Postoperative sequence chemoradiotherapy for advanced gastric cancer:an analysis of 36 cases.World Chinese Journal of Digestology,2007(36):3856-3859.
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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        <div class="pdq-content-list"><ol id="_418"><li>A prospective, multi-institution, phase III trial (<a href="/clinicaltrials/NCT01197118">SWOG-9008</a> [NCT01197118]) evaluated postoperative combined chemoradiation therapy compared with surgery alone in 559 patients with completely resected stage IB to stage IV (M0) aden
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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