A Phase II Trial Evaluating Upfront Stereotactic Body Radiotherapy in Stage III Advanced Non-small Cell Lung Cancer

NCT07565987 | Recruiting

• 1 other identifier: The APRIL Trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test the feasibility \& loco-regional control rate by combining high precision SBRT with chemotherapy in stage III NSCLC in tumor/lymph nodes if tumors/lymph node size with ≤ 6cms in size.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Loco-regional control rate

  Loco regional control rate assessment till 2 years

  2 years

Secondary Outcomes (5)

• Disease free survival

  2 years

• Overall survival

  2 years

• CTCAE V5 Toxicity

  2 years

• EORTC QLQ C30 Quality of life

  2 years

• EORTC LC-13 Quality of life

  2 years

Study Arms (1)

SBRT in stage III NSCLC

EXPERIMENTAL

The study will evaluate efficacy \& toxicity of SBRT in stage III NSCLC

Radiation: SBRT in stage III NSCLC

Interventions

SBRT in stage III NSCLC RADIATION

SBRT to primary tumor and lymph nodes in stage III NSCLC when gross disease is \< 6 cms

SBRT in stage III NSCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above and less than 75 years.
• Histologically proven non-small cell lung cancer.
• Stage T1-4, N1-3, M0 with maximum tumor size less than 6 cms and ≤ 3 stations of largest lymph node size less than 4 cms.
• ECOG status 0-1.
• Available to attend long term follow- up.
• Written informed consent for treatment.

You may not qualify if:

• Metastatic disease.
• Tumor size \> 6cm.
• Involved Lymph node size greater than 4 cms \& more than 3 station of lymph nodes involved.
• Patients with superior vena cava obstruction.
• Tumor invading/encasing the proximal bronchial tree/, esophagus, pericardium.
• Previous radiotherapy to thorax.
• Small cell histology.
• Age\< 18 or \> 75 years.
• Patients on anticoagulant therapy \& ultra-central cavitary tumors.
• Poor performance status ECOG 2-3.
• Immunocompromised states.
• Viral Markers negative.
• Pregnant women

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Nci, Aiims-Jhajjar

Jhajjar, Haryana, 124105, India

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Aman Sharma, MD

CONTACT

+91117018529339; amans757@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aman Sharma

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: May 4, 2026
• Study Start: February 1, 2023
• Primary Completion: January 30, 2025
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

IN (1)