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Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cetuximab
cisplatin
fluorouracil
leucovorin calcium
adjuvant therapy
neoadjuvant therapy
quality-of-life assessment
therapeutic conventional surgery
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring adenocarcinoma of the gastroesophageal junction, adenocarcinoma of the stomach, stage IB gastric cancer, stage IIA gastric cancer, stage IIB gastric cancer, stage IIIA gastric cancer, stage IIIB gastric cancer, stage IIIC gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

    • Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification

      • TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)
    • Disease considered operable with curative intent

  • No gastric scirrhous carcinoma (linitis plastica)

    • Forms with independent cells are not considered linitis
  • Measurable disease according to RECIST V1.1
  • No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Polynuclear neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance > 50 mL/min
  • Bilirubin < 1.5 times normal
  • Serum albumin > 30 g/L
  • Prothrombin time ≥ 80%
  • FEV1 > 1 L in case of thoracotomy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known cirrhosis

  • No other progressive condition that has not been stabilized including the following:

    • Hepatic failure
    • Renal failure
    • Respiratory failure
    • NYHA class III-IV congestive heart failure
    • Unstable angina
    • Myocardial infarction in the past 6 months
    • Significant arrhythmias in the past 12 months
  • No recent weight loss exceeding 15%
  • No interstitial pneumonia
  • No other malignant tumor within the past 5 years except for basal cell skin carcinoma or cancer in situ of the cervix
  • No psychological, familial, or geographical reasons that will preclude the patient being monitored regularly
  • No persons deprived of liberty or under guardianship (Disability Act)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy for gastric cancer
  • No other concurrent anticancer treatment, immunotherapy, or hormone therapy
  • No prior abdominal or thoracic radiotherapy

Sites / Locations

  • Centre Hospitalier Regional et Universitaire de Lille
  • CHU - Robert Debre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perioperative CT with 5FU-Cisplatine-Cetuximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate according to RECIST V1.1 criteria
Non-toxicity rate

Secondary Outcome Measures

Tolerance
Post-operative mortality and morbidity
Rate of recurrence at 1 and 2 years
Recurrence-free survival at 3 years
Disease-free survival at 3 years
Overall survival at 3 years
Quality of life as assessed by QLC-C30 and STO-22 questionnaires

Full Information

First Posted
May 20, 2011
Last Updated
May 27, 2016
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT01360086
Brief Title
Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary 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. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer
Keywords
adenocarcinoma of the gastroesophageal junction, adenocarcinoma of the stomach, stage IB gastric cancer, stage IIA gastric cancer, stage IIB gastric cancer, stage IIIA gastric cancer, stage IIIB gastric cancer, stage IIIC gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perioperative CT with 5FU-Cisplatine-Cetuximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Description
6 cycles of intravenous Cetuximab (500mg/m²),
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatine (50mg/m²)
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Surgery was planned 3-4 weeks after the end of neaodjuvant CT
Primary Outcome Measure Information:
Title
Objective response rate according to RECIST V1.1 criteria
Time Frame
3 months
Title
Non-toxicity rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tolerance
Time Frame
From Inclusion
Title
Post-operative mortality and morbidity
Time Frame
After Surgery
Title
Rate of recurrence at 1 and 2 years
Time Frame
1 year and 2 years
Title
Recurrence-free survival at 3 years
Time Frame
3 years
Title
Disease-free survival at 3 years
Time Frame
3 years
Title
Overall survival at 3 years
Time Frame
3 years
Title
Quality of life as assessed by QLC-C30 and STO-22 questionnaires
Time Frame
From inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1) Disease considered operable with curative intent No gastric scirrhous carcinoma (linitis plastica) Forms with independent cells are not considered linitis Measurable disease according to RECIST V1.1 No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I PATIENT CHARACTERISTICS: WHO performance status 0-2 Polynuclear neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine clearance > 50 mL/min Bilirubin < 1.5 times normal Serum albumin > 30 g/L Prothrombin time ≥ 80% FEV1 > 1 L in case of thoracotomy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known cirrhosis No other progressive condition that has not been stabilized including the following: Hepatic failure Renal failure Respiratory failure NYHA class III-IV congestive heart failure Unstable angina Myocardial infarction in the past 6 months Significant arrhythmias in the past 12 months No recent weight loss exceeding 15% No interstitial pneumonia No other malignant tumor within the past 5 years except for basal cell skin carcinoma or cancer in situ of the cervix No psychological, familial, or geographical reasons that will preclude the patient being monitored regularly No persons deprived of liberty or under guardianship (Disability Act) PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy or radiotherapy for gastric cancer No other concurrent anticancer treatment, immunotherapy, or hormone therapy No prior abdominal or thoracic radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Mariette, MD, PhD
Organizational Affiliation
Centre Hospitalier Regional et Universitaire de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Regional et Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU - Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24982463
Citation
Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
Results Reference
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Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction

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