NCT03623334 is a NA clinical trial of Image-Guided Radiation Therapy in Non-small Cell Lung Cancer, sponsored by University of Texas Southwestern Medical Center.

Who is sponsoring NCT03623334?

NCT03623334 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT03623334?

Interventions in NCT03623334: Image-Guided Radiation Therapy.

What condition does NCT03623334 study?

NCT03623334 studies Non-small Cell Lung Cancer.

Is NCT03623334 still recruiting?

NCT03623334 is currently completed. Last updated 4 May 2021.

Are results published for NCT03623334?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-04 · How we verify

NCT03623334

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy

Completed NA Results posted Last updated 4 May 2021

What this trial tests

NA trial testing Image-Guided Radiation Therapy in Non-small Cell Lung Cancer in 55 participants. Completed in 10 February 2018.

Timeline

5 October 2009

Primary endpoint
2 November 2012

10 February 2018

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	5 October 2009
Primary completion	2 November 2012
Estimated completion	10 February 2018

Drugs / interventions tested

Image-Guided Radiation Therapy

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 99, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose Limiting Toxicity Primary · 90 days after start of treatment up to 1 year

A dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment\*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests)

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	1
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	1
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	1

Number of Participants With Local Regional Tumor Control at 3 Months Secondary · 3 months

Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	4
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	11
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	11

Number of Participants With Local Regional Tumor Control at 6 Months Secondary · 6 months

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	2
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	5
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	8

Number of Participants With Local Regional Tumor Control at 9 Months Secondary · 9 months

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	2
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	4
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	5

Number of Participants With Local Regional Tumor Control at 12 Months Secondary · 12 months

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	1
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	1
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	4

Number of Participants With Local Regional Tumor Control at 16 Months Secondary · 16 months

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	1
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	0
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	2

Number of Participants With Local Regional Tumor Control at 20 Months Secondary · 20 months

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	1
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	0
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	0

Overall Survival at 6 Months Secondary · 6 months

Overall survival is defined as participants alive during the research period.

Group	Value	95% CI
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)	11
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)	13
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)	12

Adverse events — posted to ClinicalTrials.gov

Time frame: This was collected over a period of 12 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)

Serious: 5/15 (33%)

Deaths: 14/15

Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)

Serious: 4/21 (19%)

Deaths: 14/21

Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy

Serious: 4/19 (21%)

Deaths: 11/19

Serious adverse events (2 terms)

Reaction	System	Dose Level A: IGRT 3.33Gy …	Dose Level B: IGRT 3.67Gy …	Dose Level C: IGRT 4.00Gy …
G2 or higher dyspnea	Cardiac disorders	—	—	—
G2 or higher Esophagitis	General disorders	—	—	—

Other adverse events (30 terms — click to expand)

Reaction	System	Dose Level A: IGRT 3.33Gy …	Dose Level B: IGRT 3.67Gy …	Dose Level C: IGRT 4.00Gy …
≤G2 Esophagitis	General disorders	—	—	—
≤G2 Dyspnea	Cardiac disorders	—	—	—
Pain	Nervous system disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Anorexia	Psychiatric disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—
Dysphagia	General disorders	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Anxiety	Nervous system disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Confusion	Nervous system disorders	—	—	—
Dehydration	Gastrointestinal disorders	—	—	—
Delirium	Psychiatric disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Dysarthria	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Hypotension	Cardiac disorders	—	—	—
Neuropathy	Musculoskeletal and connective tissue disorders	—	—	—
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Thrombosis	Vascular disorders	—	—	—

Most-reported serious reactions: G2 or higher dyspnea, G2 or higher Esophagitis.

Data from ClinicalTrials.gov NCT03623334 adverse events section.

Sponsor's own description

The study is designed to determine whether daily image guidance and motion assessment/control will allow treatment of poor performance status patients with stage II-IV NSCLC, who would benefit from local therapy, with an accelerated course of hypofractionated radiation therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03623334 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 4 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03623334.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing