Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00881712
First received: April 13, 2009
Last updated: April 21, 2014
Last verified: April 2014

April 13, 2009
April 21, 2014
June 2009
July 2028   (final data collection date for primary outcome measure)
Record Grade 3 or higher rate of non-hematologic, acute treatment-related toxicities [ Time Frame: Six months after end of radiation therapy ] [ Designated as safety issue: Yes ]
Reduction of acute toxicity from combined concomitant chemotherapy and radiotherapy compared to previous cooperative group trials. [ Time Frame: Prestudy, weekly during treatment then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00881712 on ClinicalTrials.gov Archive Site
  • Disease control compared to previous cooperative group trials [ Time Frame: Following treatment every 6 months for 2 years, then annually for 4 years ] [ Designated as safety issue: No ]
  • Improvement of median, overall, and 5 year survival [ Time Frame: Five years following radiation treatment ] [ Designated as safety issue: No ]
  • Feasibility, safety and efficacy of delivering proton radiotherapy with concomitant chemotherapy [ Time Frame: Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually ] [ Designated as safety issue: Yes ]
  • Correlation of functional CT-PET imaging with treatment outcomes [ Time Frame: Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years ] [ Designated as safety issue: No ]
Disease control, median overall and 5 year survival, safety and efficacy of proton therapy and concomitant chemotherapy, correlation of functional PET or CT-PET imaging with treatment outcomes [ Time Frame: Prestudy, before surgery (if applicable) between days 18-22, then during follow-up every 6 months for 2 years, then annually for 4 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02)
A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer

The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Radiation: PET positive nodal disease measuring 15 mm or greater
    Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy.
    Other Name: Proton Radiation
  • Radiation: PET positive nodal disease measuring less than 15 mm
    Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy.
    Other Name: Proton Radiation
  • Radiation: Patients considered resectable
    Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed.
    Other Name: Proton Radiation
  • Experimental: PET positive nodal disease measuring 15 mm or greater
    Proton radiation with concomitant chemotherapy
    Intervention: Radiation: PET positive nodal disease measuring 15 mm or greater
  • Experimental: PET positive nodal disease measuring less than 15 mm
    Proton radiation
    Intervention: Radiation: PET positive nodal disease measuring less than 15 mm
  • Experimental: Patients considered resectable
    Proton radiation plus surgery
    Intervention: Radiation: Patients considered resectable

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
April 2035
July 2028   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
  • Patient must be at least 18 years old at the time of consent.
  • Stage III A or III B disease.
  • Patients must be able to start study treatment within 6 weeks of study enrollment.
  • Induction chemotherapy is allowed.
  • Marginally resectable or unresectable at presentation.
  • If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.

Exclusion Criteria:

  • Evidence of distant metastasis.
  • Prior thoracic radiotherapy.
  • Any history of allergic reaction to taxanes.
  • Prior tumor resection. Candidate for upfront curative surgery.
  • Pleural effusion visible on chest x-ray or the scout view of the CT chest.
  • Unintentional weight loss within the month prior to diagnosis ≥ 10%.
  • Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
  • The presence of PET positive contralateral hilar disease.
Both
18 Years and older
No
Contact: Intake Coordinator 877-686-6009
United States
 
NCT00881712
UFPTI 0802-LU02
Yes
University of Florida
University of Florida
Not Provided
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
University of Florida
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP