Study to evaluate the efficacy and safety of chemotherapy & Radiation therapy vs observation following surgery in patients with esophageal cancer

Phase 2

Conditions: Health Condition 1: - Health Condition 2: K228- Other specified diseases of esophagus

Registration Number: CTRI/2019/05/019335

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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:

a.Pulmonary complications:

pneumonia (isolation of a pathogen from sputum culture and a new or progressive infiltrate on chest x-ray),

serious atelectasis (lobar collapse on chest x-ray),

pneumothorax (collection of air between the visceral and parietal surfaces, requiring drainage)

pleural effusion (collection of fluid between the visceral and parietal surfaces, requiring drainage)

pulmonary embolism (embolus detected on a spiral CT scan or on a ventilation-perfusion mismatch on a lung scintigram),

acute respiratory failure (partial pressure of arterial oxygen <60 mm Hg while breathing ambient air).

b cardiac complications

arrhythmia (any change in rhythm on the ECG, requiring treatment)

myocardial infarction (two or three of the following:previous myocardial infarction, electrocardiographic changes suggestingmyocardial infarction, or enzyme changes suggesting myocardial infarction)

left ventricular failure (markedpulmonary edema on a chest radiograph).

c. Chylothorax- diagnosed by elevated levels of triglycerides in intrathoracic fluid ( >1 mmol per liter or 89 mg/dl)

d. Mediastinitis

e. Anastomotic leakages diagnosed on physical or radiologic examination. Leakage was classified as subclinical if it was diagnosed on radiologic examination or endoscopyand as clinical if a salivary fistula was present.

7. Adequate bone marrow function (hemoglobin > 8 g/L, platelets > 100 x 109/L, absolute neutrophil count (ANC) > 1.5 x 109/L)

8. Adequate liver function (ALT/AST < 2.5 x ULN, serum bilirubin < 2 x ULN)

9. Adequate renal function (creatinine clearance > 50 ml/min)

10. Women of childbearing potential must be willing to consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. A man who is the partner of a woman of childbearing potential must be willing to consent to using effective contraception (e.g., vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.

11. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals.

12. Signed, written informed consent.

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.