Health Condition 1: C15- Malignant neoplasm of esophagus
Conditions
Interventions
Intervention1: Docetaxel, Cisplatin/Carboplatin and 5-FU/Capecitabine: 5FU will be dosed at 750 mg/m2 continuous intravenous infusion on days 1 to 5. Cisplatin will be dosed at 75 mg/m2on day 1 of eac
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have histologically proven squamous cell carcinoma of the esophagus or esophagogastric junction 2. Tumour should be surgically resectable. Pre-treatment stage cT24a, N0-3, M0. Cervical esophageal cancers should be resectable without the need for laryngectomy. 3. Male or female or Transgender subjects aged 18-75 years of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Subjects must have normal organ and marrow function 6. Patients with HIV are potentially eligible, as long as they have a CD4 count more than 200, are on concurrent HAART highly active antiretroviral therapy, and absence of active AIDS defining conditions. 7. Negative serum or urine pregnancy test at screening for women of childbearing potential. 8. Women of childbearing potential must be willing to consent to using effective contraception 9. Both men and women of all races and ethnic groups are eligible for this study. 10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Subjects who are receiving any other concurrent investigational agents. 2. Clinical or radiologic evidence of metastatic disease. 3. Patients unfit for curative surgery for any reason. 4. Infections Active infection requiring systemic therapy. 5. Hepatitis B virus or hepatitis C virus infection at screening positive HBV surface antigen with a raised HBV DNA or anti HCV antibody screening test positive with raised HCV RNA. Mere presence of HBV or HCV at screening test will not rule the patient out. 6. Hypersensitivity to study drug Known prior severe hypersensitivity to investigational product or any component in its formulations. 7. Clinically significant cardiovascular disease unstable angina, congestive heart failure 8. Other severe acute or chronic medical conditions including inflammatory bowel disease, pneumonitis, chronic kidney disease, known peripheral neuropathy more than grade 1 9. Pregnant women are excluded from this study 10. Any other malignancies within the last 5 years other than curatively treated basal cell carcinoma of the skin and or in situ carcinoma of the cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS)Timepoint: At death | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS ORR Toxicity QOL R zero Resection rates Pathological response rates Tumour regression grades Peri and postoperative complication rates patterns of treatment failure local vs locoregional vs distant Factors that impact OS Gender ECOG baseline body weight baseline haemoglobin baseline albumin histopathological grade Axial Imaging Factors that impact PFS Gender ECOG baseline body weight baseline haemoglobin baseline albumin histopathological grade Axial ImagingTimepoint: 1. At progression 2. At progression 3. every visit 4. QOL for Arm A At baseline, week 5 of chemoradiation, first follow up visit post chemoradiation completion, first follow up visit post-surgery, 2 months , 4 months | — |
Countries
India
Contacts
Public ContactDr Minit Shah
Tata Memorial Hospital
Outcome results
None listed