← Back to Search

Alkylating agents

Paclitaxel for Lung Cancer

Phase 3
Waitlist Available
Led By Jeffrey Bradley, MD
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Nodal recurrence must be N1 or N2; N3 is not eligible.
The initial primary must have been staged as T1-2, N0, M0.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to one year
Awards & highlights

Study Summary

This trial is studying standard-dose or high-dose radiation therapy given with or without cetuximab and chemotherapy to treat patients with stage III non-small cell lung cancer.

Eligible Conditions
  • Lung Cancer
  • Radiation Poisoning

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Death During or Within 30 Days of Discontinuation of Protocol Treatment
EuroQoL (EQ5D) Visual Analog Scale (VAS) Through One Year (Area Under the Curve)
Local-regional Failure (Reported as Two-year Estimates)
+9 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 74 Gy RT + CetuximabExperimental Treatment4 Interventions
74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Group II: 74 Gy RTExperimental Treatment3 Interventions
74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Group III: 60 Gy RT + CetuximabExperimental Treatment4 Interventions
60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Group IV: 60 Gy RTActive Control3 Interventions
60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
60 Gy RT
2007
Completed Phase 3
~550
74 Gy RT
2007
Completed Phase 3
~550
Cetuximab
2011
Completed Phase 3
~2480
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
231 Previous Clinical Trials
100,280 Total Patients Enrolled
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,383 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,615 Previous Clinical Trials
40,918,153 Total Patients Enrolled

Frequently Asked Questions

~31 spots leftby Mar 2025