A study of Oral chemotherapy after completion of radiation and chemotherapy vs observation in Carcinoma esophagus.

Phase 3

Conditions: Health Condition 1: null- Patients of carcinoma of esophagus

Registration Number: CTRI/2015/09/006204

Lead Sponsor: Tata Memorial Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

1.Patients with histologic or cytologic diagnosis of squamous cell carcinoma of the esophagus or GEJ

2.Completed definitive radical CTRT, with at least 50 Gy of radiation within the preceding12 weeks, concurrently with one of the following chemotherapy regimens:

•Paclitaxel 50mg/m2 and Carboplatin AUC 2 given weekly-at least 5 doses.

•Cisplatin, at least 30mg/m2, given weekly-at least 5 doses.

•5FU 750 to 1000 mg/m2 CIVI for 4-5 days and cisplatin 75 to 100mg/m2on day 1, given 3 weekly-at least 2 doses.

3.Age >=18 years

4.ECOG performance status PS 0-2

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

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

7.Adequate renal function (creatinine clearance > 45 ml/min)

8.Women of childbearing potential must be willing to consent to using effective contraception (eg, 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 (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.

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

10.Signed, written informed consent.

Exclusion Criteria

1.Clinical or radiologic evidence of metastatic disease.

2.Progressive disease at disease reassessment post CTRT.The presence of stable disease on restaging is permissible, however the patient should not have new sites of disease or an increase in disease (that qualifies for PD as per RECIST, or is determined to be PD by the radiologist or the investigator) as compared to the pre-CTRT scan.

3.QTc prolongation (QTc interval prolonged more than 0.5seconds)

4.Known hypersensitivity to methotrexate, celecoxib or sulfonamides.

5.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.

6.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.

7.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.

8.History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

9.History of malignancy other than esophagogastric cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or othermalignancies curatively treated with no evidence of disease for >5 years.

10.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.