CTRI/2019/05/019335
Not yet recruiting
Phase 2
A randomized clinical trial evaluating the efficacy and safety of the addition of postoperative chemoradiation versus observation in patients with high-risk esophageal squamous cell carcinoma following surgery
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: - Health Condition 2: K228- Other specified diseases of esophagus
- Sponsor
- Tata Memorial Hospital
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Patients with histologic or cytologic diagnosis of squamous cell carcinoma of the esophagus or gastroesophageal junction.
- •2 Age \>\=18 years
- •3 ECOG performance status (PS) 0\-2
- •4 Patient has undergone curative intent esophagectomy with lymph node dissection.
- •5 Histopathology specimen from esophagectomy shows at least one of the following high\-risk features:
- •a \> 2 positive lymph nodes
- •b 1 lymph node positive with extracapsular extension.
- •c Positivemargins (circumferential/ proximal/ distal).
- •d Poor response to induction chemotherapy, as evidenced by tumor regression grade (TRG) \>3
- •6 No persistent major surgical morbidity following esophagectomy, including:
Exclusion Criteria
- •1 Clinical or radiologic evidence of metastatic disease.
- •2 R2 resection at the time of esophagectomy.
- •3 Any significant active infection, including chronic active hepatitis B, active hepatitis C, HIV infection with AIDS or immunodeficiency syndromes. Testing for these is not mandatory unless clinically indicated. Participants with known hepatitis B/C infection will be allowed to participate, provided evidence of viral suppression has been documented and the patient remains on appropriate anti\-viral therapy.
- •4 Serious uncontrolled medical illness (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, severe infection or untreated psychiatric conditions) that might limit the ability of the patient to comply with the protocol.
- •5 Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule, including alcohol dependence or drug abuse.
- •6 History of malignancy other than esophagogastric cancer, except adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix or other malignancies curatively treated with no evidence of disease for \>5 years.
- •7 Pregnancy, lactation, or inadequate contraception. Women must be post\-menopausal, infertile, or willing to use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilized or be willing to use a (double if required) barrier method of contraception.
Outcomes
Primary Outcomes
Not specified
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