NCT01186978 (DLBCL) is a NA clinical trial of Radiation Therapy in Diffuse Large B-cell Lymphoma, sponsored by Duke University.

Who is sponsoring NCT01186978?

NCT01186978 is sponsored by Duke University.

What drugs are being tested in NCT01186978?

Interventions in NCT01186978: Radiation Therapy.

What condition does NCT01186978 study?

NCT01186978 studies Diffuse Large B-cell Lymphoma.

Is NCT01186978 still recruiting?

NCT01186978 is currently completed. Last updated 2 June 2020.

Are results published for NCT01186978?

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

Last reviewed 2020-06-02 · How we verify

NCT01186978: DLBCL

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

Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

Completed NA Results posted Last updated 2 June 2020

What this trial tests

NA trial testing Radiation Therapy in Diffuse Large B-cell Lymphoma in 63 participants. Completed in 4 June 2019.

Timeline

20 September 2010

Primary endpoint
4 June 2019

4 June 2019

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	20 September 2010
Primary completion	4 June 2019
Estimated completion	4 June 2019
Sites	3 locations across United States

Drugs / interventions tested

Radiation Therapy — full drug profile →

Conditions studied

Diffuse Large B-cell Lymphoma — all drugs for Diffuse Large B-cell Lymphoma →

Sponsor

Duke University

Who can join

Adults 18 to 80, any sex, with Diffuse Large B-cell Lymphoma. 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 Local Control Primary · 5 years

This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.

Group	Value	95% CI
Single Arm	61

Percentage of Participants With Progression-free Survival at 5 Years Secondary · 5 years

Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first.

Group	Value	95% CI
Single Arm	83	67 – 93

Percentage of Participants With Overall Survival Secondary · 5 years

Overall survival will be defined as the number of participants who are alive

Group	Value	95% CI
Single Arm	90	73 – 98

Number of Participants With Local, Distant, or Local+Distant Failure Secondary · 5 years

To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only.

Local failure

Group	Value	95% CI
Single Arm	1

Distant failure

Group	Value	95% CI
Single Arm	6

Local+distant failure

Group	Value	95% CI
Single Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm

Serious: 4/63 (6%)

Deaths: 3/63

Serious adverse events (3 terms)

Reaction	System	Single Arm
Squamous cell carcinoma	Skin and subcutaneous tissue disorders	—
Papillary thyroid cancer	Endocrine disorders	—
Papillary carcinoma of the kidney	Renal and urinary disorders	—

Other adverse events (16 terms — click to expand)

Reaction	System	Single Arm
Nausea	Gastrointestinal disorders	—
Non-cardiac chest pain	Respiratory, thoracic and mediastinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Odynophagia	Gastrointestinal disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Vomiting	Gastrointestinal disorders	—
Ear fullness	Ear and labyrinth disorders	—
Dental caries	Gastrointestinal disorders	—
Dysgeusia	General disorders	—
Gastroesophageal reflux	Gastrointestinal disorders	—
Oral mucositis	Gastrointestinal disorders	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—
Post-nasal drip	Respiratory, thoracic and mediastinal disorders	—
Leukopenia	Blood and lymphatic system disorders	—
Idiopathic cardiomyopathy	Cardiac disorders	—
Depressed ejection fraction	Cardiac disorders	—

Most-reported serious reactions: Squamous cell carcinoma, Papillary thyroid cancer, Papillary carcinoma of the kidney.

Data from ClinicalTrials.gov NCT01186978 adverse events section.

Sponsor's own description

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity. Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.

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 trials of Radiation Therapy

Trials testing the same drug.

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NCT07466316 — A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Ove · Phase 3 · not yet recruiting

Other recruiting trials for Diffuse Large B-cell Lymphoma

Currently open trials in the same condition.

NCT06977711 — Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large · Phase 1 · recruiting
NCT06846463 — Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+ · Phase 2 · recruiting
NCT06870487 — A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers · Phase 1 · active not recruiting
NCT06651853 — Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL · Phase 2 · recruiting
NCT06503263 — Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL · Phase 2 · recruiting

Other Duke University trials

Trials by the same sponsor.

NCT07216456 — Vaginal Dilator Therapy After Pelvic Radiation · NA · not yet recruiting
NCT07519317 — Dosing and Deployment Trial: A Home-based Optokinetic Treatment · NA · not yet recruiting
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · 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 NCT01186978 (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 Duke University
Last refreshed: 2 June 2020

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/NCT01186978.

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