Chemotherapy for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Malignant Neoplasms+2 More
Chemotherapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a prospective multi-center randomized clinical trial designed to demonstrate that daily online adaptive radiotherapy with concomitant chemotherapy for stage III non-small cell lung cancer (NSCLC) will result in decreased acute respiratory and esophageal toxicity compared with non-adaptive radiotherapy with concomitant chemotherapy. The timepoint for this assessment will be 1 month following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Eligible Conditions

  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasms

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: From randomization to 30 days after completion of chemoradiotherapy

Month 12
Local progression
Radiation pneumonitis
Month 12
Overall response rate
Month 2
Mean normal tissue doses
Normal lung tissue radiation exposure
Month 12
Global quality of life
Lung cancer specific quality of life
Day 30
Acute toxicity

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasms

Trial Design

2 Treatment Groups

Non-Adaptive Arm
1 of 2
Adaptive Arm
1 of 2
Active Control
Experimental Treatment

244 Total Participants · 2 Treatment Groups

Primary Treatment: Chemotherapy · No Placebo Group · N/A

Adaptive ArmExperimental Group · 3 Interventions: Adaptive Radiotherapy, Immunotherapy, Chemotherapy · Intervention Types: Device, Drug, Drug
Non-Adaptive ArmActiveComparator Group · 3 Interventions: Non-Adaptive Radiotherapy, Immunotherapy, Chemotherapy · Intervention Types: Device, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adaptive Radiotherapy
2007
Completed Phase 2
~160
Immunotherapy
2016
Completed Phase 4
~1020
Chemotherapy
2003
Completed Phase 4
~2960

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to 30 days after completion of chemoradiotherapy
Closest Location: University of Alabama at Birmingham · Birmingham, AL
Photo of university of alabama at birmingham 1Photo of university of alabama at birmingham 2Photo of university of alabama at birmingham 3
1991First Recorded Clinical Trial
0 TrialsResearching Malignant Neoplasms
1070 CompletedClinical Trials

Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor
17 Previous Clinical Trials
5,791 Total Patients Enrolled
Dennis Stanley, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Andrew McDonald, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient must have a whole body FDG PET-CT scan performed within 60 days prior to enrollment.
Patients who refuse surgery must have a clear indication for surgery.
You have a primary tumor in the lung that is stage IIIC due to contralateral mediastinal lymph node involvement only.
Brain MRI or contrast enhanced CT within 60 days prior to enrollment.
You are considered clinically fit for chemoradiotherapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.