Study of Adjuvant Radiochemotherapy for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188266
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 20, 2017
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

September 9, 2005
September 16, 2005
September 20, 2017
August 2002
December 19, 2013   (Final data collection date for primary outcome measure)
  • Phase I and II: Acute toxicity: assessed according to National Cancer Institute of Canada (NCIC) and Radiation Therapy Oncology Group (RTOG) toxicity assessment criteria. [ Time Frame: 10 years ]
  • Phase II: Comparison of acute toxicity rates with those observed in their previous study of 20 patients treated similarly to the SWOG INT 0116 protocol. [ Time Frame: 10 year ]
  • Phase I and II: The primary outcome of this study is acute toxicity, which will be assessed according to NCIC and RTOG toxicity assessment criteria.
  • Phase II: We will compare acute toxicity rates with those observed in our previous study of 20 patients treated similarly to the SWOG INT 0116 protocol.
Complete list of historical versions of study NCT00188266 on Archive Site
  • Monitor 1 and 2 year local recurrence [ Time Frame: 10 years ]
  • Survival and disease-specific survival [ Time Frame: 10 years ]
- monitor 1 and 2 year local recurrence, survival and disease-specific survival
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Study of Adjuvant Radiochemotherapy for Gastric Cancer
Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer

In 1991, the South West Oncology Group (SWOG) conducted a randomized study of adjuvant chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cGy/25 fractions) versus surgery alone for patients with completely resected gastric carcinoma.

This landmark study showed the benefit of adjuvant treatment for gastric cancer and radically changed the treatment of this disease. However, the resulting standard treatment has severe acute toxicity, and despite this advance, 50% of patients still die of gastric cancer. The investigators hope to develop a modified protocol using active chemotherapy agents, but with reduced acute toxicity. Such an approach could ultimately be studied against the current SWOG approach to determine whether or not the addition of cisplatinum improves efficacy.

Patients who decide to participate in the study will receive a chemotherapy drug called 5-Fluorouracil (5FU)through an intravenous catheter continuously over 12 weeks. Patients will not be admitted to hospital to receive the chemotherapy but will need to wear a waist pack to carry a small pump that will deliver the medication. They will however need to make regular visits to have their medication bags changed. Patients will also receive Cisplatin intravenously every 2 weeks for 4 doses. In addition, patients will also receive radiation to their stomach, lymph nodes, and the area where they had their surgery. This study also comprise of a questionnaire for us to see how patient's cancer and treatment is affecting their quality of life. Patients will have regular follow-up by their physicians.

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Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stomach Neoplasms
Drug: cisplatinum combined with infusional fluorouracil (5 FU)
Continuous 5FU via intravenous PICC line + 4 doses of Cisplatin every 2 weeks
Experimental: 5-Fluorouracil (5FU) and Cisplatin with Radiation
Intervention: Drug: cisplatinum combined with infusional fluorouracil (5 FU)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 18, 2017
December 19, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • R0 resection (no microscopic residual) of adenocarcinoma of stomach or gastroesophageal (GE) junction, prior to starting chemotherapy and radiation
  • Tumor must not extend more than 2 cm along the esophagus; bulk of the tumor must be in the stomach.
  • Adequate pre-operative cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
  • International Union Against Cancer (UICC)/American Joint Committee on Cancer (AJCC) Stage IB - IV, excluding patients with metastatic disease (T1N1, T2N0 to T4N1, N2, and any T, N3). T2N0 eligible only if disease extends beyond muscularis propria.
  • No previous abdominal radiotherapy or contraindication to radiotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2
  • Adequate major organ function
  • Nutritional intake of at least 1500 calories per day at nutrition assessment
  • Treatment started within 20-90 days post-op of surgery date.
  • Informed consent

Exclusion Criteria:

  • Less than 70 years of age
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
UHN REB 02-0134-C
Not Provided
Not Provided
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Jolie Ringash, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP