Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients Wi… (NCT00938470) | Clinical Trial Compass
CompletedPhase 2
Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
United States73 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 no…
What they're measuring
1
Percentage of Participants With Pathologic Complete Response (PCR)