Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: cisplatin; irinotecan hydrochloride; therapeutic conventional surgery; radiation therapy
Intervention description: Given IV; Given IV; Undergo Surgery; Undergo radiation
Intervention MeSH terms: Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer

Summary:

      This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together
      with radiation therapy works in treating patients with esophageal cancer or gastroesophageal
      junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin
      and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Giving 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.
    

Eligibility criteria:

        -  Histologically or cytologically confirmed adenocarcinoma, poorly differentiated
             carcinoma, or carcinoma not otherwise specified, of the esophagus or gastroesophageal
             junction; biopsy or cytology of the primary tumor, or of involved regional lymph
             nodes, is acceptable

          -  Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic
             ultrasound; T1 tumors are eligible if they are T1, N1, M0; regional thoracic lymph
             node involvement (N1) is permitted

          -  Disease must be clinically limited to the esophagus or gastroesophageal junction; if
             the tumor extends below the gastroesophageal junction into the proximal stomach, 50%
             of the tumor must involve the distal esophagus or gastroesophageal junction;
             adenocarcinomas of the distal esophagus would therefore include tumors of the distal
             esophagus, or Siewert type I according to the Siewert classification, and tumors of
             the gastroesophageal junction which involve equally both the distal esophagus and
             proximal stomach, or Siewert type II; tumor must be surgically resectable

               -  No TIS (in-situ carcinoma) and tumors determined to be T1N0 following endoscopic
                  ultrasound

               -  No clinical involvement on endoscopic ultrasound (EUS), computed tomography (CT)
                  scan, or PET scan of supraclavicular or celiac lymph node involvement (stage IVa,
                  T any N any M1a) unless this is proven to be a false positive by an appropriate
                  biopsy

               -  No patients with cervical esophageal tumors, or gastric cancers with minor
                  involvement of the gastroesophageal junction or distal esophagus

               -  No patients with tracheoesophageal fistulas

          -  Patients with evidence of metastatic disease are not eligible; this includes:

               -  Positive malignant cytology of the pleura, pericardium or peritoneum

               -  Radiographic evidence of distance organ involvement including lung, liver, bone,
                  or brain

          -  No prior chemotherapy or radiotherapy is permitted; patients must be at least 4 weeks
             since major surgery, or must have recovered from the effects of minor surgery
             (laparoscopy, thoracoscopy)

          -  No prior malignancies (other than basal cell/squamous carcinoma of the skin, in-situ
             cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted
             unless diagnosed and/or treated >= 3 years before registration and without evidence of
             recurrence

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  No evidence of recurrent laryngeal nerve or phrenic nerve paralysis

          -  No known Gilbert's disease

          -  No clinically significant hearing loss; audiograms should be done in patients in which
             they are clinically indicated

          -  No history of active seizure disorder; no ongoing treatment with phenytoin,
             phenobarbital, or other antiepileptic medication; patients who are receiving valproic
             acid are eligible

          -  No New York Heart Association class III or IV heart disease; no angina or myocardial
             infarction within the last 6 months

        Inclusion Criteria:

          -  No history of clinically significant ventricular arrhythmia requiring ongoing
             medication with antiarrhythmics

          -  Absolute neutrophil count (ANC) >= 1,500/ul

          -  Platelet count >= 100,000/ul

          -  Hemoglobin >= 9 gm/dl

          -  Serum creatinine =< upper limit of normal (ULN)

          -  Total serum bilirubin =< 1.5 mg/dl

          -  Forced expiratory volume in 1 second (FEV-1) >= 1.2 liters OR >= 35% of normal as a
             value that is indexed to body size

          -  Pulmonary function tests (PFT) >= 1.2 liters OR >= 35% of normal as a value that is
             indexed to body size