Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified Health Condition 2: C158- Malignant neoplasm of overlappingsites of esophagus
Conditions
Interventions
Intervention1: Neoadjuvant Chemoradiation Vs Neoadjuvant Chemotherapy before surgery in carcinoma esophagus: Patient to receive either neoadjuvant chemoradiation or Neoadjuvant Chemotherapy before def
Sponsors
TMH TRAC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically documented untreated SCC of the esophagus. 2.Primary tumor of the esophagus located in the thoracic cavity. The proximal extent would be at least 5 cm from the upper esophageal sphincter and the distal extent up to the gastroesophageal (GE) junction. The length and width of the tumor will not exceed 8 cm and 5 cm, respectively. However, patients with mid- esophageal tumors and tracheoesophageal nodes would be included. 3.Pre-treatment stage as cT2 4aN0 2M0 (AJCC or UICC 8th Edition) (In the case of stage cT4a, curative resectability must be explicitly verified by the local surgical investigator before randomization). 4.Age - between 18 years and 75 years. 5.Patients having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6.Adequate cardiac function. Patients with a cardiac history or ECG abnormality will undergo echocardiography and be included if the left ventricular ejection fraction is =55%. 7.Patients with adequate pulmonary function assessed with a pulmonary function test (PFT) or DLCO would be included. FEV1 should be greater than or equal to 50 percent or DLCO greater than or equal to 50 percent in PFT. 8.Adequate bone marrow function (haemoglobin greater than 8 gm per Lit, platelets greater than 100 multiplied 109 per Lit, absolute neutrophil count (ANC) greater than 1.5 multiplied 109 per Lit. 9.Adequate liver function (Total bilirubin less than 2 multiplied Upper Level of Normal (ULN), Aspartate transaminase (AST) and Alanine transaminase (ALT) less than 2.5 multiplied ULN). 10.Adequate renal function (Creatinine clearance (CrCl) greater than 40 ml per min Carboplatin dose calculation as per AUC. 11.The patient has provided written informed consent and can understand and comply with the study.
Exclusion criteria
Exclusion criteria: 1. Patients with non-squamous cell carcinoma histology 2. Patients with advanced inoperable or metastatic esophageal cancer; 3. Patients with lower esophageal tumors with supraclavicular nodes or upper or mid esophageal tumors with gastrohepatic or coeliac nodes. 4. Pre-treatment stage as cN3 or cT4b. 5. Patients with another previous or current malignant disease that is likely to interfere with treatment or the assessment of response in the judgment of the local surgical investigator. 6. Any patient with a significant medical condition due to which the patient is unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within the last 12 months), clinically significant lung disease, clinically significant bone marrow, liver, and renal function disorder. 7. Pregnant or lactating and fertile women who will not be using contraception during the trial. 8. Expected lack of compliance with the protocol. 9. Patients who have received any previous treatment for oesophageal cancer. 10.Patients are unsuitable for surgery because of comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be Disease-free survival (DFS) in the intent- to-treat population at 2 years: It is defined as the time from the date of R0 resection to the date of failure (local, regional, or distant) or death. Failure will be examined by CT, PET-CT, and or upper endoscopy and confirmed by biopsy.Timepoint: The Disease free survival will be calculated in 2 year interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Post Operative pathological stage. 2.Treatment-related complications: The data will be recorded according to the International Consensus of Esophagectomy Complications Consensus Group (ECCG). Chemoradiation chemotherapy-related toxicities during the preoperative time are collected according to CTCAE version 5.0. 3.Postoperative mortality: 30-day postoperative mortality. 4.Pattern of Failure- local, distant, or both. 5.Quality of life (QOL): QOL will be respectively evaluated at randomization, 4 weeks after neoadjuvant therapy and 3 monthly after surgery up to 12 months by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) and QLQ – OES18. 6.Cost Benefit Analysis Total cost including the cost of treatment logistics investigations and cost in terms of financial loss due to loss of livelihood during the treatment including employed attendants.Timepoint: Overall Survival: till the death of subject. Progression free survival: 2 years Postoperative mortality: 30 days QOL: taken at every 3 months ;7.Recurrence free survival (RFS) time It is defined as the time from the date of surgery to the date of the first recurrence (local, regional, or distant) or death assessed. Recurrence is examined by CT, PET CT, and or upper endoscopy and confirmed by biopsy. 8.Progression free survival (PFS) time in the intent to treat population at a minimum follow up of 2 years. It is defined as the time from the date of randomization to the date of first recurrence or progression (local, regional, or distant) or death. Progression is examined by computed tomography (CT) and or positron emission tomography computed tomography (PET CT) and or upper endoscopy and is to be confirmed by biopsy. 9.Overall survival time: Overall survival is calculated from the date of randomization to the date of death due to any cause. For patients alive at study closure, the survival time will be censored at the time of the last kno | — |
Countries
India
Contacts
Public ContactDr Ajay Kumar Choubey
Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital
Outcome results
None listed