A trial to evaluate a shorter course of chemoradiotherapy before surgery for esophageal cancer and to determine its safety, effectiveness and optimal dose

Hypofractionated Neoadjuvant Chemoradiotherapy in Operable Esophageal Cancer: A study to evaluate efficacy, safety and optimal dosing - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082212

Enrollment

Registered

2025-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: C158- Malignant neoplasm of overlappingsites of esophagus

Interventions

Intervention1: Hypofractionated Neoadjuvant Chemoradiotherapy: In operable esophageal cancer, trial participants will be treated by giving two cycles of weekly chemotherapy (paclitaxel 50mg/m2 and car

Eligibility

Inclusion criteria

Inclusion criteria: Histologically confirmed squamous cell carcinoma/adenocarcinoma Tumors with epicenter in middle/lower third of esophagus or gastroesophageal junction (Sievert I/II) WHO performance status less than or equal to 2 cT1N+M0 or cT2-4aN0/+M0 according to the AJCC 8th edition of TNM staging based on endoscopic findings & cross-sectional imaging (CECT thorax & abdomen OR WB-PET/CT) Adequate hematologic, hepatic, renal, cardiac & pulmonary functions Suitable for esophagectomy following neoadjuvant treatment Written informed consent

Exclusion criteria

Exclusion criteria: Presence of distant metastasis (M1) on cross sectional imaging Sievert type III tumours Previous chemotherapy, radiotherapy, or surgery for esophageal cancer. Presence of serious comorbid conditions such as cardiovascular/pulmonary/autoimmune diseases Any contraindications to chemotherapy/radiotherapy Any invasive malignancy in previous two years (excluding non-melanomatous skin carcinoma or cervical carcinoma in situ) Women who are pregnant or currently breastfeeding.

Design outcomes

Primary

Measure	Time frame
Assessment of pathological complete response (pCR) rate after neoadjuvant hypofractionated chemoradiotherapy in operable esophageal cancer.Timepoint: 8 weeks after completion of chemoradiation	—

Secondary

Measure	Time frame
Analysis of progression-free survival (PFS) and overall survival (OS)Timepoint: 1 year;Assess safety and tolerability via RTOG/EORTC toxicity grading and CTCAE v5.0. criteria Timepoint: Weekly assessment during chemoradiation followed by 3 monthly review upto 1 year;Quality of life (QoL) assessment using EORTC QLQ-C30, OES18, OG25 questionnairesTimepoint: Prior to starting treatment followed by 3 monthly review upto 1 year;Assessment of surgical outcomes such as R0 resection rates and postoperative morbidity and mortality.Timepoint: 4 weeks after surgery;Identification of the optimal radiation dose & regimen of hypofractionated chemoradiotherapy and to assess impact on pCR rates and toxicity profiles.Timepoint: Upto 1 year	—

Measure

Time frame

Analysis of progression-free survival (PFS) and overall survival (OS)Timepoint: 1 year;Assess safety and tolerability via RTOG/EORTC toxicity grading and CTCAE v5.0. criteria Timepoint: Weekly assessment during chemoradiation followed by 3 monthly review upto 1 year;Quality of life (QoL) assessment using EORTC QLQ-C30, OES18, OG25 questionnairesTimepoint: Prior to starting treatment followed by 3 monthly review upto 1 year;Assessment of surgical outcomes such as R0 resection rates and postoperative morbidity and mortality.Timepoint: 4 weeks after surgery;Identification of the optimal radiation dose & regimen of hypofractionated chemoradiotherapy and to assess impact on pCR rates and toxicity profiles.Timepoint: Upto 1 year

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Countries

India

Contacts

Public ContactDr Samiran Chavan

All India Institute of Medical Sciences, Jodhpur

drpuneetpareek@gmail.com9167859574

Outcome results

None listed

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