Study of Adjuvant Radiochemotherapy for Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT00188266|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 20, 2017
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 or disease||Intervention/treatment||Phase|
|Stomach Neoplasms||Drug: cisplatinum combined with infusional fluorouracil (5 FU)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer|
|Actual Study Start Date :||August 2002|
|Actual Primary Completion Date :||December 19, 2013|
|Actual Study Completion Date :||August 18, 2017|
|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
- 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 ]
- Monitor 1 and 2 year local recurrence [ Time Frame: 10 years ]
- Survival and disease-specific survival [ Time Frame: 10 years ]
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
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Jolie Ringash, MD||Princess Margaret Hospital, Canada|