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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.


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer

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Trial Information

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.


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate according to RECIST V1.1 criteria

Safety Issue:

No

Principal Investigator

Christophe Mariette, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Regional et Universitaire de Lille

Authority:

Unspecified

Study ID:

CDR0000699219

NCT ID:

NCT01360086

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Cancer
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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