Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction
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|ClinicalTrials.gov Identifier: NCT01360086|
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : May 30, 2016
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Gastroesophageal Junction Gastric Cancer||Biological: cetuximab Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery||Phase 2|
- To evaluate the objective response rate according to RECIST V1.1 criteria in patients with adenocarcinoma of the stomach or gastroesophageal junction treated with neoadjuvant chemotherapy comprising fluorouracil, cisplatin, leucovorin calcium, and cetuximab followed by surgery and adjuvant chemotherapy.
- To determine the non-toxicity rate in these patients.
- To determine the rate of macroscopically and microscopically complete surgical resection (R0).
- To determine the overall tolerance in patients treated with this regimen.
- To determine post-operative mortality and morbidity in these patients.
- To determine the rate of recurrence at 1 and 2 years in these patients.
- To determine recurrence-free survival at 3 years in these patients.
- To determine disease-free survival at 3 years in these patients.
- To determine overall survival at 3 years in these patients.
- To determine quality of life using EORTC QLC-C30 and STO-22 questionnaires.
- To determine the correlation between the response rate and the degree of skin toxicity.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy and surgery: Patients receive leucovorin calcium IV over 2 hours, cisplatin IV, fluorouracil IV continuously over 46 hours, and cetuximab IV over 1-2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks after completing neoadjuvant chemotherapy, patients undergo surgery.
- Adjuvant therapy: Within 4-8 weeks after completing neoadjuvant chemotherapy, patients receive leucovorin calcium, cisplatin, fluorouracil, and cetuximab as in neoadjuvant therapy. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires (QLC-C30 and STO-22) periodically. Blood and tissue samples are collected periodically for correlative and translational studies.
After completing study therapy, patients are followed up every 4 months for 2 years and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Experimental: Perioperative CT with 5FU-Cisplatine-Cetuximab
6 cycles of intravenous Cetuximab (500mg/m²), Cisplatine (50mg/m²) and LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks. Surgery was planned 3-4 weeks after the end of neaodjuvant CT and postoperative CT, with the same regimen, planned for 6-8 weeks after surgery.
6 cycles of intravenous Cetuximab (500mg/m²),Drug: cisplatin
Cisplatine (50mg/m²)Drug: fluorouracil
LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeksDrug: leucovorin calcium Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery
Surgery was planned 3-4 weeks after the end of neaodjuvant CT
- Objective response rate according to RECIST V1.1 criteria [ Time Frame: 3 months ]
- Non-toxicity rate [ Time Frame: 3 months ]
- Tolerance [ Time Frame: From Inclusion ]
- Post-operative mortality and morbidity [ Time Frame: After Surgery ]
- Rate of recurrence at 1 and 2 years [ Time Frame: 1 year and 2 years ]
- Recurrence-free survival at 3 years [ Time Frame: 3 years ]
- Disease-free survival at 3 years [ Time Frame: 3 years ]
- Overall survival at 3 years [ Time Frame: 3 years ]
- Quality of life as assessed by QLC-C30 and STO-22 questionnaires [ Time Frame: From inclusion ]
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): NCT01360086
|Centre Hospitalier Regional et Universitaire de Lille|
|Lille, France, 59037|
|CHU - Robert Debre|
|Reims, France, 51092|
|Principal Investigator:||Christophe Mariette, MD, PhD||Centre Hospitalier Regional et Universitaire de Lille|