Chemoradiation for advanced unresectable esophageal and gastroesophageal junction cancer

Phase 3

• Conditions: Health Condition 1: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs

• Registration Number: CTRI/2018/08/015564
• Lead Sponsor: TATA MEMORIAL HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with histologic or cytologic diagnosis of carcinoma (squamous cell carcinoma or adenocarcinoma) of the esophagus or gastroesophageal junction.

2.Age >= 18 years

3.ECOG performance status (PS) 0-2

4.Patient is planned for definitive intent concurrent CRT

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

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

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

8.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.

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.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.

3.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.

4.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.

5.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.

6.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.

7.Use of an investigational agent within the preceding 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified