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Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer

Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Stomach Neoplasms

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Trial Information

Prospective Phase I/II Study of Adjuvant Radiochemotherapy for Gastric Cancer

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Jolie Ringash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Review Ethics Committee

Study ID:

UHN REB 02-0134-C



Start Date:

August 2002

Completion Date:

August 2016

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms