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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAll India Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SBRT in stage III NSCLC

    Radiation

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SBRT in stage III NSCLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Loco-regional control rate

Loco regional control rate assessment till 2 years

Time frame
2 years

Secondary outcomes

1

Disease free survival

Longitudinal assessment every 2 months for initial six months and every 3 months till next 2 years

Time frame
2 years
2

Overall survival

Longitudinal assessment every 2 months for initial six months and every 3 months till next 2 years

Time frame
2 years
3

CTCAE V5 Toxicity

CTCAE Grades Grade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Assessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly

Time frame
2 years
4

EORTC QLQ C30 Quality of life

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Assessed at base line, post SBRT, post Chemotherapy, first follow up, at 6 months and then 6 monthly

Time frame
2 years

Other outcomes

Sponsors and contacts

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