Overview

This trial is active, not recruiting.

Conditions adenocarcinoma of the gastroesophageal junction, esophageal cancer, gastric cancer
Treatments capecitabine, docetaxel, fluorouracil, oxaliplatin, radiation therapy, therapeutic conventional surgery
Phase phase 2
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date January 2010
End date March 2014
Trial size 96 participants
Trial identifier NCT00938470, CDR0000646724, NCCTG-N0849, NCI-2011-01930

Summary

This randomized phase II trial studies how well docetaxel, oxaliplatin, capecitabine, fluorouracil, and radiation therapy works compared with fluorouracil when given together with oxaliplatin and radiation therapy in treating patients with cancer of the esophagus or gastroesophageal junction that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as docetaxel, oxaliplatin, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive capecitabine PO BID 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.
capecitabine
Given PO
docetaxel
Given IV
fluorouracil
Given IV
oxaliplatin
Given IV
radiation therapy
Undergo radiation therapy
therapeutic conventional surgery
Undergo surgery
(Active Comparator)
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.
fluorouracil
Given IV
oxaliplatin
Given IV
radiation therapy
Undergo radiation therapy
therapeutic conventional surgery
Undergo surgery

Primary Outcomes

Measure
Pathologic complete response (PCR) rate
time frame: Up to 2 years

Secondary Outcomes

Measure
Overall survival
time frame: Up to 2 years
Disease-free survival
time frame: Up to 2 years
Adverse events assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
time frame: Up to 2 years
Overall clinical tumor response rate (CR or PR)
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Histological confirmation of adenocarcinoma of the esophagus, gastroesophageal (GE) junction, or gastric cardia - Tumor must be considered surgically resectable; Note: patients with T4N0M0 tumors that are potentially resectable are also eligible - Nodal involvement: patients with involvement of celiac nodes, (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus or GE junction; patients with supraclavicular node involvement are eligible with upper thoracic esophagus primary lesions - Capable of swallowing pills - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 - Absolute neutrophil count (ANC) >= 1500 - Peripheral platelet count >= 100,000 - Hemoglobin >= 9.0 g/dL - Total bilirubin =< 1.5 x upper normal limit (UNL) - Serum glutamic oxaloacetic transaminase (SGOT) (alanine aminotransferase [AST]) =< 3 x UNL - Creatinine =< 1.5 x UNL - Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Provide informed written consent - Willingness to return to NCCTG enrolling institution for follow-up - Patient willing to provide mandatory tissue and blood samples for research purposes - Patient willing to allow use of FDG PET/CT scans for mandatory research purposes Exclusion Criteria - Evidence of distant metastases - 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 - T1N0M0 or T2N0M0 tumor stage - Any of the following - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - Co-morbid systemic illnesses or other severe concurrent disease which, 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 - Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Uncontrolled diabetes (i.e., will interfere with the performance of the FDG PET/CT scans) - Receiving current treatment or prior treatment for this malignancy - Other active malignancy 5 years prior to registration, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for cancer - Prior radiation to > 30% of the marrow cavity

Additional Information

Official title Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
Description PRIMARY OBJECTIVES: I. To assess and compare the pathologic complete response (PCR) rate of patients in Arm A receiving the sequence docetaxel, oxaliplatin, and capecitabine (DOC) followed by 5-fluorouracil (5-FU), oxaliplatin, and radiation therapy (RT) with patients in Arm B receiving only 5-FU, oxaliplatin and RT in patients with potentially resectable adenocarcinoma (ACA) of the esophagus, gastroesophageal junction (GEJ), or gastric cardia. SECONDARY OBJECTIVES: I. To assess the adverse event (AE) profile and safety of the proposed treatment in this population. II. To assess and compare the overall survival (OS) between treatment arms. III. To assess and compare the disease-free survival between treatment arms. IV. To assess and compare the clinical tumor response rate of the proposed regiments when administered before surgery between treatment arms. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and oxaliplatin IV over 2 hours on day 1. Patients also receive capecitabine orally (PO) twice daily (BID) 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. After completion of study treatment, patients are followed up every 3 months for 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.