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Study of Adjuvant Radiochemotherapy for Gastric Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188266
First Posted: September 16, 2005
Last Update Posted: September 20, 2017
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.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms Drug: cisplatinum combined with infusional fluorouracil (5 FU) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Monitor 1 and 2 year local recurrence [ Time Frame: 10 years ]
  • Survival and disease-specific survival [ Time Frame: 10 years ]

Estimated Enrollment: 65
Actual Study Start Date: August 2002
Study Completion Date: August 18, 2017
Primary Completion Date: December 19, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5-Fluorouracil (5FU) and Cisplatin with Radiation Drug: cisplatinum combined with infusional fluorouracil (5 FU)
Continuous 5FU via intravenous PICC line + 4 doses of Cisplatin every 2 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188266


Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Jolie Ringash, MD Princess Margaret Hospital, Canada
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188266     History of Changes
Other Study ID Numbers: UHN REB 02-0134-C
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Cisplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs