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Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia



- Assess and compare the pathologic complete response rate of sequential docetaxel,
oxaliplatin, and capecitabine followed by fluorouracil, oxaliplatin, and radiotherapy
versus fluorouracil, oxaliplatin, and radiotherapy alone in patients with potentially
resectable advanced adenocarcinoma of the esophagus, gastroesophageal junction, or
gastric cardia.


- Assess the adverse event profile and safety of these regimens in this patient

- Assess and compare the overall survival of patients treated with these regimens.

- Assess and compare the disease-free survival between treatment arms.

- Assess and compare the clinical tumor response rate of these proposed regimens when
administered before surgery between treatment arms.

- Evaluate the profiles of pharmacogenetic and proteomic marker measures over time, and
assess the association of changes in these biomarkers induced by these proposed
regimens with pathologic tumor response and other outcomes of interest.

- Evaluate the profiles of FDG PET/CT measures, including standardized uptake values and
% injected dose in the tumor volume over time, and assess the correlation of changes in
PET measures with pathologic tumor response and other outcomes of interest.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0-1 vs 2), and disease stage (II vs III/IVA). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day
1. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable
toxicity. After completion of the second course, patients receive fluorouracil* IV
continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy** 5 days a week for 5.5 weeks in the absence of
disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion
of radiotherapy, patients undergo surgery.

- Arm II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV
over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery
as in arm I.* NOTE: * Fluorouracil continuous IV infusion begins within 24 hours of
radiotherapy and ends within 24 hours of radiotherapy completion.

NOTE: ** Radiotherapy should begin within 2-6 weeks after completion of 2 courses of
docetaxel, oxaliplatin, and capecitabine.

Blood samples are collected at baseline and periodically during study for pharmacogenetic
(genetic polymorphisms along with drug target pathways) and proteomic markers (microRNA and
mRNA expression) studies. Tumor tissue samples from biopsy and surgery are also collected
for pharmacogenetic and proteomic markers studies and future correlative studies.

After completion of study therapy, patients are followed up every 3-6 months for 2 years.

Inclusion Criteria


- Histologically confirmed locally advanced adenocarcinoma of the esophagus,
gastroesophageal (GE) junction, or gastric cardia

- Surgically resectable disease

- T4N0M0 tumors that are potentially resectable allowed

- T1N0M0 or T2N0M0 tumors not allowed

- Nodal involvement:

- Involvement of celiac nodes (stations 15-20) allowed if the primary lesion is
mid-thoracic, distal esophagus, or GE junction

- Supraclavicular node involvement allowed with upper thoracic-esophagus primary

- No palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular
nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest
dimension) for lesions in mid-thoracic, distal thoracic, or GE junction

- No evidence of distant metastases


- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to swallow pills

- Willing to return to NCCTG enrolling institution for follow-up

- Willing to provide mandatory tissue and blood samples for research purposes

- Willing to undergo FDG PET/CT scans for mandatory research purposes

- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Not immunocompromised unless related to the use of corticosteroids

- No known HIV positivity

- No uncontrolled intercurrent illness including, but not limited to, the following

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness and/or social situations that would limit compliance with
study requirements

- No uncontrolled diabetes

- No other active malignancy, except for non-melanoma skin cancer or carcinoma in-situ
of the cervix, unless curatively treated with no evidence of disease within the past
5 years and not on concurrent specific treatment for cancer other than hormonal


- No prior radiotherapy to ≥ 30% of the marrow cavity

- No prior or other concurrent treatment for this malignancy

- No concurrent intensity-modulated radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate

Safety Issue:


Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Gastric Cancer
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the gastroesophageal junction
  • stage IIIA gastric cancer
  • stage IIIB gastric cancer
  • stage IIIC gastric cancer
  • stage IIIA esophageal cancer
  • stage IIIB esophageal cancer
  • stage IIIC esophageal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



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