Health Condition 1: C158- Malignant neoplasm of overlappingsites of esophagus
Conditions
Interventions
Intervention1: Neoadjuvant Short Course Radiotherapy in Combination with Chemotherapy for Squamous Cell Carcinoma of Esophagus: NACT: Neoadjuvant chemotherapy will be given to all patients included i
Sponsors
All India Institute of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must provide written informed consent and demonstrate an understanding of the research requirements, criteria, and evaluation schedule. 2. Participants must be between the ages of 18 and 75 years on the enrollment date (inclusive). 3. An endoscopic biopsy must confirm the presence of a newly diagnosed localized esophageal carcinoma in the thoracic region. 4. Histological confirmation of squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma is required. 5. Tumors must be located in the mid or lower thoracic esophagus or at the gastroesophageal junction (below 25 cm on upper gastrointestinal endoscopy). 6. According to RECIST version 1.1 and PERCIST criteria, there must be measurable or evaluable lesions. 7. Participants should have an ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2. 8. Clinical staging must be T1-4aN+M0 or T3-4aN0M0 (up to stage IVA) according to the 8th edition of the UICC-TNM classification. 9. No prior history of cancer treatment, including chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or any other investigational drugs for other malignancies. 10. The tumor is expected to be resectable based on multidisciplinary team (MDT) discussions.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received any treatment for esophageal squamous cell carcinoma (ESCC). 2. Patients at high risk of gastrointestinal haemorrhage or fistula formation (between the esophagus and bronchus or aorta). 3. Patients with severe malnutrition, defined as a body mass index (BMI) of less than 18 kg/m or a PG-SGA score of 9 or higher. 4. Patients with significant tumor invasion into mediastinal structures, such as tracheal infiltration, involvement of the atrium, contiguous lung infiltration, extensive contact with the trachea or main bronchi, or indentation of the tumor into the tracheal or bronchial lumen observed via bronchoscopy. 5. Presence of gross nodal disease in supraclavicular, scalene, or cervical lymph node stations. 6. Supra-carinal infiltrative nodal disease with evidence of extra-nodal extension on imaging. 7. A history of treatment for any prior malignancy. 8. Known allergies to any medications utilized in this study. 9. Pregnant or lactating women who are unwilling to use contraception. 10. A history of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiencies, or prior organ or bone marrow transplants requiring immunosuppressive therapy. 11. Patients who refuse to provide consent for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess Safety (assessed up to 2 weeks post-therapy) and efficacy (assessed post-surgery and 2 weeks post-therapy) of Neoadjuvant Short Course Radiotherapy with Neoadjuvant Chemotherapy in Squamous cell Carcinoma Esophagus.Timepoint: Safety assessed up to 2 weeks post-therapy; efficacy assessed post-surgery and 2 weeks post-therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess 1-year Progression Free Survival (PFS, from the date of enrollment until disease progression, recurrence, death, or the last day of follow-up), Disease-free survival (DFS is the amount of time after primary cancer treatment that a patient lives without any signs or symptoms of cancer), Time-to-recurrence (TTR, which is defined as the time from date of curative surgery to the time of recurrence) & Overall Survival (OS, the time from the date of enrollment to the date of death from any cause or the last date of follow-up)Timepoint: 1 year after surgery;2) To assess the rate of completion of neoadjuvant therapy (both for chemotherapy & radiotherapy) & surgical conversion rate (number of patients who could be taken up for surgery after successful completion of neoadjuvant therapy as per the protocol), overall response rate (ORR) & rate of R0 resection (complete tumor removal)Timepoint: 2 weeks after neoadjuvant therapy & 2 weeks after surgery on final histopathology report;3) To compare intra-operative complications & postoperative complications (evaluated by Clavien - Dindo criteria) & surgical morbidity in this regimenTimepoint: At the time of Surgery, in the post operative period upto 30 days, then 90 days | — |
Countries
India
Contacts
Public ContactRohan Kapoor
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed