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A Phase II Trial of Induction Chemotherapy With Epirubicin, Oxaliplatin and Fluorouracil (EOF) Followed by Esophagogastrectomy and Post-operative Concurrent Chemoradiotherapy With Fluorouracil and Cisplatin, in Patients With Loco-regionally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction and Gastric Cardia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Phase II Trial of Induction Chemotherapy With Epirubicin, Oxaliplatin and Fluorouracil (EOF) Followed by Esophagogastrectomy and Post-operative Concurrent Chemoradiotherapy With Fluorouracil and Cisplatin, in Patients With Loco-regionally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction and Gastric Cardia


OBJECTIVES:

Primary

- To assess the feasibility and tolerability of induction chemotherapy comprising
epirubicin hydrochloride, oxaliplatin, and fluorouracil (EOF), followed by surgical
resection and postoperative concurrent chemoradiotherapy comprising fluorouracil and
cisplatin in patients with locoregionally advanced adenocarcinoma of the esophagus,
gastroesophageal junction, or gastric cardia.

Secondary

- To determine the rate of complete and partial response to three courses of EOF
induction chemotherapy.

- To compare the recurrence-free and overall survival of patients treated with this
regimen vs historical controls at this institution.

- To compare patterns of failure in patients treated with this regimen vs historical
controls at this institution.

OUTLINE:

- Induction chemotherapy: Patients receive epirubicin hydrochloride IV over 3-15 minutes
and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-21.
Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.

- Surgery: Four weeks after completion of induction chemotherapy, patients with
locoregionally confined disease (T0-4, N0-1, M0-1a) undergo transthoracic
esophagogastrectomy or total gastrectomy with Roux-en-Y esophagojejunostomy, depending
on the location and extent of the tumor at the time of surgery.

- Postoperative chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo
radiotherapy 5 days a week for approximately 6 weeks. Patients also receive
fluorouracil IV continuously and cisplatin IV continuously over 96 hours in weeks 1 and
4 of radiotherapy.

After completion of study treatment, patients are followed every 8-12 weeks for 3 years.


Inclusion Criteria:



- Patients must have a histologic diagnosis of adenocarcinoma of the esophagus,
gastroesophageal junction or gastric cardia, based on biopsy material or adequate
cytologic exam.

- Patients must be clinically staged according to the AJCC 2002 staging system and must
have either T3-4, or N1 or M1a disease. Staging should include at least an upper
endoscopy with endoscopic ultrasound and an FDG-PET/CT scan.

- Patients must have an ECOG performance status of 0-1.

- Patients must have adequate bone marrow function as evidenced by: Absolute neutrophil
count > 1,500/uL Platelet count > 100,000/uL

- Patients must have adequate renal function as evidenced by serum creatinine < 1.6
mg/dL

- Patients must have adequate hepatic function as evidenced by:Serum total bilirubin <
1.5 mg/dL Alkaline phosphatase < 3X the institutional ULN AST/ALT < 3X the
institutional ULN

- Patients must have adequate pulmonary function as evidenced by an FEV1 > 50%
predicted.

- Patients or their legal representatives must be able to read, understand, provide and
sign informed consent to participate in the trial.

- Patients of childbearing potential agree to use an effective form of contraception
during the study and for 90 days following the last dose of study medication (an
effective form of contraception is an oral contraceptive or a double barrier method)

- Age > 18 years

Exclusion Criteria:

- Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma,
small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma etc,) will be
ineligible.

- Patients with any evidence of distant hematogenous or distant nodal disease (M1b)
will be ineligible.

- No prior chemotherapy, radiation therapy or surgery for this malignancy will be
allowed. Prior endoscopic debulking, laser therapy or dilatation will not exclude a
patient.

- Patients with another active malignancy will not be eligible except for curatively
treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or
localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive
evaluations at least 3 months apart, with the most recent evaluation within 4 weeks
of entry

- Patients with an active infection will not be eligible.

- Patients with known hypersensitivity to any of the components of oxaliplatin,
epirubicin, fluorouracil or cisplatin will not be eligible.

- Patients who are receiving any other concurrent investigational therapy, or who have
received investigational therapy within 30 days of the first scheduled day of
protocol treatment (investigational therapy is defined as treatment for which there
is currently no regulatory authority approved indication) will not be eligible.

- Patients with a baseline peripheral neuropathy greater than or equal Grade 2 will not
be eligible.

- Patients who are pregnant or lactating will not be eligible.

- Patients with any other medical condition, including mental illness or substance
abuse, deemed by the Investigator to be likely to interfere with a patient's ability
to sign informed consent, cooperate and participate in the study, or interfere with
the interpretation of the results, will not be eligible.

- Patients with any history of an allogeneic transplant will not be eligible.

- Patients with known infection with HIV, Hepatitis B or C (active, previously treated
or both) will not be eligible.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of resectability rate

Outcome Description:

Prior experience at this institution suggests a resectability rate after induction chemoradiotherapy of 85-90%, primarily based on disease extent at the time of surgery. Resectability below 75% will suggest that this induction regimen is not feasible. Similarly, prior experience suggests that post-operative chemoradiotherapy can be given to between 70-80% of resected patients. If adjuvant chemoradiotherapy cannot be given to at least 65% of the resected patients on this trial, the feasibility of this schedule will be in doubt.

Outcome Time Frame:

3 cycles

Safety Issue:

No

Principal Investigator

David J. Adelstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE2Y07

NCT ID:

NCT00601705

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the stomach
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • stage II esophageal cancer
  • stage II gastric cancer
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195