Neoadjuvant Short course radiotherapy in esophageal carcinoma

Phase 2 single arm study to evaluate safety and efficacy of neoadjuvant short course radiotherapy along with chemotherapy followed by surgery in resectable carcinoma of esophagus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029851

Enrollment

Registered

2020-12-16

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: C159- Malignant neoplasm of esophagus, unspecified

Interventions

Intervention1: Neoadjuvant short course radiotherapy along with weekly chemo: Neoadjuvant short course radiotherapy (25 Gy in 5 Fractions) along with weekly chemotherapy using paclitaxel and carboplat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically Proven Esophageal or Gastroesophageal junction (Sievert 1 or 2) Carcinoma patients who are medically fit for surgery 2. Stage II to IVA 3. Age: 18-70 years 4. ECOG: 0-2 5. Normal hemodynamic indices before the recruitment (including white blood cell count >4.0Ã?109/L, neutrophil count >1.5Ã?109/L, platelet count >100Ã?109/L, hemoglobin>=90g/l, normal liver/kidney function) 6. Able to understand this study and have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Have been previously treated with chemotherapy, radiotherapy and other anti-tumour treatment except surgery for non GI cancer 2. Known or suspected allergy to paclitaxel or carboplatin; 3. Female in pregnancy or lactating; 4. Patients with significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent; 5. Patients with peripheral neuropathy (CTC grade>=2); 6. The patient not tolerant to neoadjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, immune system diseases, nervous system diseases, cachexia, etc.

Design outcomes

Primary

Measure	Time frame
Pathological Complete Response (pCR) rates in the resected specimenTimepoint: post surgery (week 9 - 11)	—

Secondary

Measure	Time frame
Assess quality of lifeTimepoint: Baseline, post neoadjuvant chemoRT, 3 months post treatment;R0 (Complete resection) ratesTimepoint: Postoperatively;To estimate 30-day perioperative morbidityTimepoint: 30 day perioperative morbidity;To estimate 30-day perioperative mortalityTimepoint: 30-day perioperative mortality;To estimate the acute toxicities related to the regimenTimepoint: During treatment	—

Countries

India

Contacts

Public ContactDr Deepa Joseph

AIIMS Rishikesh

drdeepajoseph@yahoo.com08978386509

Outcome results

None listed

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