Radiation dose escalation in esophageal cancers by advanced radiation technique

A phase 2 study of simultaneous integrated boost (SIB) based radiation dose escalation in squamous cell carcinoma of esophagus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/028108

Enrollment

Registered

2020-09-28

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: C154- Malignant neoplasm of middle thirdof esophagus Health Condition 2: C153- Malignant neoplasm of upper thirdof esophagus

Interventions

Intervention1: Radiation dose escalation: Radiation dose escalation by Simultaneous Integrated Boost by Volumeteric modulated arc radiotherapy (VMAT) technique.Radiation dose of 60/62 Gy in 25/28 # wi

Eligibility

Inclusion criteria

Inclusion criteria: 1. ECOG performance status 0-2 2. Cervical, upper, middle and lower thoracic esophagus within 2cm of gastro-esophageal junction 3. No distant metastasis 4. Planned with radical intent 5. Normal hematological, renal and liver function 6. No history of prior chest radiotherapy

Exclusion criteria

Exclusion criteria: 1. Presence of tracheoesophageal fistula 2. Length of lesion including lymph nodes >10 cm 3. History of prior malignancy 4. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
To assess local control at 2 yearsTimepoint: 6-12 weeks post treatment and at 1 and 2 years	—

Secondary

Measure	Time frame
1.To assess acute and late toxicities 2. To assess disease free survival and overall survival at 2 years 3. To assess quality of life using EORTC QLQC 30 and EORTC QLQ OES 18 questionnaires 4. To assess cardiac changes using ECHO Timepoint: 1. Acute toxicities will be assessed upto 90 days from start of radiotherapy 2. To assess late toxicities upto 2 years from radiotherapy 3. Quality of life assessment at baseline, end of treatment, 3 months, 6 months, 12 months and 24 months after treatment 4. Cardiac changes at baseline , 3 months, 6 months, 12 months and 24 months after treatment	—

Measure

Time frame

1.To assess acute and late toxicities 2. To assess disease free survival and overall survival at 2 years 3. To assess quality of life using EORTC QLQC 30 and EORTC QLQ OES 18 questionnaires 4. To assess cardiac changes using ECHO Timepoint: 1. Acute toxicities will be assessed upto 90 days from start of radiotherapy 2. To assess late toxicities upto 2 years from radiotherapy 3. Quality of life assessment at baseline, end of treatment, 3 months, 6 months, 12 months and 24 months after treatment 4. Cardiac changes at baseline , 3 months, 6 months, 12 months and 24 months after treatment

—

Countries

India

Contacts

Public ContactDr Kannan P

PGIMER CHANDIGARH

pkannan10011988@gmail.com

Outcome results

None listed

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