Comparative study of different dose regimens for neoadjvant chemoradiotherapy in operable squamous cell carcinoma of oesophagus

COMPARATIVE STUDY OF TWO DIFFERENT DOSE FRACTIONATION SCHEDULES OF NEOADJUVANT CHEMORADIOTHERAPY IN RESECTABLE SQUAMOUS CELL CARCINOMA OF ESOPHAGUS: A PHASE II RANDOMISED CONTROLLED TRIAL - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/107132

Enrollment

124

Registered

2026-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified

Interventions

Intervention1: Escalated Dose NACRT: 50.4Gy in 28 fractions along with weekly chemotherapy(carboplatin and paclitaxel) over 6 weeks followed by surgery Control Intervention1: Standard Dose NACRT: 41.4

Eligibility

Inclusion criteria

Inclusion criteria: Histologically confirmed oesophageal squamous cell carcinoma Clinically staged Any T, Any N, M0 ECOG 0 1 Planned for NACRT followed by esophagectomy

Exclusion criteria

Exclusion criteria: Cervical oesophageal cancers Prior thoracic radiation Unresectable disease or distant metastasis Medical contraindications to chemotherapy or surgery

Design outcomes

Primary

Measure	Time frame
Pathological Complete Response (pCR) Timepoint: Post Surgery	—

Secondary

Measure	Time frame
To record treatment-related toxicities during radiotherapy, at completion and at every follow-up using CTCAE 5.0 scale.Timepoint: During radiotherapy;To assess perioperative complications using Clavien-Dindo classification.Timepoint: after surgery; To assess various prognostic factors associated with treatment response e.g. Age, Gender, Size of the Node, T-stage, history of smoking, alcohol consumption etc.Timepoint: 3 months;To assess the pattern of failure- Locoregional Failure, Distant MetastasesTimepoint: 3 months	—

Measure

Time frame

To record treatment-related toxicities during radiotherapy, at completion and at every follow-up using CTCAE 5.0 scale.Timepoint: During radiotherapy;To assess perioperative complications using Clavien-Dindo classification.Timepoint: after surgery; To assess various prognostic factors associated with treatment response e.g. Age, Gender, Size of the Node, T-stage, history of smoking, alcohol consumption etc.Timepoint: 3 months;To assess the pattern of failure- Locoregional Failure, Distant MetastasesTimepoint: 3 months

—

Countries

India

Contacts

Public ContactDr Jyotiman Nath

Dr Bhubaneswar Borooah Cancer Institute

jyotimannath@gmail.com9401512763

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026