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Effect of preoperative concurrent chemoradiotherapy in patients with adenocarcinoma of esophagus

Preoperative chemoradiation and surgery versus surgery alone in gastroesophageal junction adenocarcinoma of oesophagus â??A Randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/003981
Enrollment
160
Registered
2013-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients with ECOG (0,1,2) - Good performance status

Interventions

Intervention1: cisplatin , 5-Fu , radiotherapy ,surgery: Cisplatin will be administered in a dose of 20 mg/m2/day on day 1, 2, 3, 17, 18 and 19. 5-flurouracil will be administered in a dose of 750 mg/

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2. Adenocarcinoma 3. Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2) i.e the patient should not be spending more than 50% of his time in Bed. 4. Swallowing capacity at preop or preop neoadjuvant is a minimum of oral intake (liquid or semisolid) 5. Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact 6. No evidence of distant metastasis on CECT of neck , thorax and abdomen.

Exclusion criteria

Exclusion criteria: 1. Patient refuses consent for the study 2. Co-morbid conditions which would preclude oesophagectomy a. Poor performance status (ECOG > 2) b. American Society of Anesthesiologists class IV 3. Metastatic disease detected on evaluation 4. Involvement of mediastinal structures as described in the inclusion criteria 5. Carcinoma involving upper third of the esophagus. 6. Previous radiotherapy or chemotherapy

Design outcomes

Primary

MeasureTime frame
resectability rate, postoperative morbidity and operative mortalityTimepoint: resectability rate, postoperative morbidity and operative mortality

Secondary

MeasureTime frame
treatment compliance , early disease control (at 1 year) and assess the treatment toxicity of preoperative chemoradiation.Timepoint: till 2 years

Countries

India

Contacts

Public ContactDrPeush Sahni

aiims

peush_sahni@hotmail.com01126593461

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026