Phase 2
N=55
Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
Gastric Adenocarcinoma · Stage II Gastric Cancer · Stage III Gastric Cancer · Stage IV Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00062374 ↗Enrolled (actual)
55
Serious AEs
25.5%
Results posted
Jul 2017
Primary outcome: Primary: Histological Response Determined by FDG Uptake Correlates — 2; 3; 38 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin (Drug); Computed Tomography (Procedure); Fludeoxyglucose F-18 (Radiation); Fluorothymidine F-18 (Other); Irinotecan Hydrochloride (Drug); Positron Emission Tomography (Procedure); Therapeutic Conventional Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histological Response Determined by FDG Uptake Correlates |
2; 3; 38 | — |
Summary
This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.
Eligibility Criteria
Inclusion Criteria
- All patients must have microscopically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction with material reviewed by the Department of Pathology of the participating Institution; tumors involving the GE junction must have the bulk of their disease in the stomach; tumors of the distal esophagus that extend less than 2cm into the stomach are ineligible for this study; using the Siewert's classification for the GE junction, tumors designated as Types II and III are indeed considered eligible for this clinical trial
- All patients must have localized cancer potentially curable by surgery; the tumor stage should be Tany N+ M0 or T3-T4 Nany M0, by staging that includes a computed tomography (CT) scan and either laparoscopy-assisted pancreatobiliary (LAP) or endoscopic ultrasound (EUS); patients with T1-2N0M0 tumors, confirmed by LAP ("good risk") are ineligible; any sites of suspected M1 disease by these criteria must be proven to be M0 prior to entrance into a neoadjuvant trial
- Patients must have a Karnofsky Performance Status >= 60% (Eastern Cooperative Oncology Group [ECOG] = = 1,500 cells/mm^3
- Platelets >= 100,000/mm^3
- Serum creatinine = 5 years will be allowed to enter the trial
- Clinically significant hearing loss
Data sourced from ClinicalTrials.gov (NCT00062374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.