Oxaliplatin 85 mg/m2 in 2 hours intravenous infusion, + S-leucovorin 200 mg/m2, + 5-FU 2,400 mg/m2 as a 46 hours continuous infusion. The cycles are repeated every 2 weeks for a total of 8 cycle, if tumor response is stable disease, partial or complete response, then maintenance with Capecitabine 1,000 mg twice a day will be administered until disease progression, unacceptable toxicity or treatment refusal by the patient.

Metastatic Gastric Cancer

Oxaliplatin 85 mg/m2 is given as a 2 hours intravenous infusion, concomitant to and S-leucovorin 200 mg/m2, and followed by 5-FU 2,400 mg/m2 as a 46 hours continuous infusion.

FOLFOX

Capecitabine 1,000 mg twice a day will be administered until disease progression, unacceptable toxicity or treatment refusal by the patient.

Capecitabine

International group of endovascular oncology (IGEVO) website

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio San Salvatore,

Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer

Modified Folinic Acid-Fluorouracil-Oxaliplatin (FOLFOX) Followed by Capecitabine as First-line Chemotherapy for Elderly or Frail Patients With Metastatic or Recurrent Gastric Cancer

Vincenzo Catalano

International Group of Endovascular Oncology

PreOp Chemotherapy: 2 cycles (each cycle consisting of 4 weeks or 2 treatments) of chemotherapy with oxaliplatin, folinic acid and infusional 5-FU (FOLFOX-48). Oxaliplatin 100 mg/m^2 over 2 hours on day 1, folinic acid intravenous (IV) at 200 mg/m^2 over 30 minutes on day 1, and 5-FU 2,200 mg/m^2 over 48 hours as continuous infusion by outpatient pump starting on day 1. This therapy, FOLFOX-48 repeated every 2 weeks x 4 (8 weeks of induction chemotherapy).
PreOp Chemoradiotherapy begins 12 days after last dose of PreOp Chemo 5FU plus oxaliplatin; A total of 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2/d Monday through Friday) & weekly oxaliplatin 45 mg/m^2 over 2 hours for 5 weeks (oxaliplatin administered on the first day of radiation week).
Surgical resection 4-6 weeks after completion of chemoradiotherapy

FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid & infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2 for 5 days) & weekly oxaliplatin 45 mg/m^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy

5-Fluorouracil + Folinic Acid + Oxaliplatin

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

The complete pathologic response (path CR) rate after treatment calculated as the percentage of participants with path CR out of the total participants, where the path CR is defined as absence of tumor cells in the surgical specimen and all registered participants are used in the denominator for calculating the path CR rate.
Primary gastric carcinoma is not measurable by conventional criteria thus usual response criteria cannot be applied. The following criteria for response assessment applied: Pathologic Complete Response: Absence of tumor cells in the surgical specimen, 95% or more necrosis of the cancer; Complete Clinical Response: Absence of tumor on endoscopy, biopsy, cytology, or both.

FOLFOX-48 PreOp Chemotherapy (2 Cycles) with oxaliplatin, folinic acid & infusional 5-FU repeated every 2 weeks x 4 (8 weeks of induction chemotherapy). PreOp Chemoradiotherapy following PreOp Chemo 5FU plus oxaliplatin for total 45 Gy (1.8 Gy fx/d) of radiotherapy concurrent to low-dose continuous infusion of 5-FU (300 mg/m^2 for 5 days) & weekly oxaliplatin 45 mg/m^2 for 5 weeks (oxaliplatin administered on the first day of radiation week). Surgical resection 4-6 weeks after completion of chemoradiotherapy.

Complete Pathologic Response Rate

Overall Study

Dr. Jaffer Ajani, MD / Professor, GI Medical Oncology

Stomach Cancer

Gastric Cancer

2.2 Gm/m^2 By Vein Over 48 Hours On Days 1, 15, 29, and 43.
Chemoradiotherapy: 300 mg/m2 a day Monday through Friday, by continuous infusion during radiation through an outpatient portable pump.

5-Fluorouracil

200 mg/m^2 by vein Over 30 Minutes On Days 1, 15, 29, and 43.

Folinic Acid

100 mg/m^2 By Vein Over 2 Hours On Days 1, 15, 29, and 43.
Chemoradiotherapy: 45 mg/m^2 over 2 hours weekly for 5 weeks during radiation. (oxaliplatin should be administered on the first day of the radiation week).

Oxaliplatin

45 Gy (1.8 Gy fx/day) Monday through Friday, 12 days after the last dose of 5FU plus oxaliplatin and no later than 28 days.

Radiotherapy

4-6 weeks after completion of chemoradiotherapy, restaged & surgical resection of the primary tumor and lymph nodes attempted.

Surgery

University of Texas MD Anderson Cancer Center Website

University of Texas MD Anderson Cancer Center

Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)

A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction

folinic acid/fatigue

Modified Folinic Acid-Fluorouracil-Oxaliplatin Regimen + Capecitabine for Elderly With Metastatic Gastric Cancer

Preoperative Chemo and Chemoradiotherapy for Adenocarcinoma of the Stomach and Gastroesophageal Junction (GEJ)

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