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
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Radiation: PET positive nodal disease measuring 15 mm or greater
Radiation: PET positive nodal disease measuring less than 15 mm
Radiation: Patients considered resectable
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 78
Study Start Date: June 2009
Estimated Study Completion Date: April 2035
Estimated Primary Completion Date: July 2028 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET positive nodal disease measuring 15 mm or greater
Proton radiation with concomitant chemotherapy
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
Experimental: PET positive nodal disease measuring less than 15 mm
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
Experimental: Patients considered resectable
Proton radiation plus surgery
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881712

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Bradford S Hoppe, MD, MPH         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Nichols RC, Henderson RH, Huh SN, Flampouri S, Cury JD, Pham DC, D'Agostino HJ, Louis D, Li Z, Mendenhall NP. Proton Radiotherapy Offers Reduced Bone Marrow and Normal Lung Exposure for Patients Receiving Dose Escalated Radiotherapy with Concomitant Chemotherapy for Regionally Advanced Non-Small Cell Lung Cancer. Presented at the LALCa 2008 - 3rd Latin American Conference on Lung Cancer - Tercera Conferencia Latinoamericana sobre Cancer Pulmonar - Vina del Mar, Chile - October 9 and 10, 2008
Komaki R, Sejpal S, Wei X, et al. Reduction of Bone Marrow Suppression for Patients with Stage III NSCLC Treated by Proton and Chemotherapy Compared with IMRT and Chemotherapy. Proceedings of the PTCOG 47, May 19-24, 2008.
Curran W, Scott C, Langer C, et al. Long term benefit is observed in a phase III comparison of sequential vs. concurrent chemo-radiation for patients with unresectable NSCLC: RTOG 9410. Proc Am Soc Clin Oncol 2003;61(abstr).
Martel MK, et al. Incidental doses to clinically negative nodes from conformal treatment fields for non-small cell lung cancer. Int J Rad Oncol Biol Phys. 45(3 (supplement)): 244, 1999.
Albain KS, Swann RS, Rusch VR, et al. Phase III study of concurrent chemotherapy and radiotherapy (CT/RT) vs. CT/RT followed by surgical resection for stage IIIA (pN2) non-small cell lung cancer (NSCLC): Outcomes update of North American Intergroup 0139 (RTOG 9309). Proc Am Soc Clin Oncol, abstract 7014, 2005.
Vokes E, Herndon J, Turrisi A. Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable non-small cell lung cancer (NSCLC): Initial analysis of a randomized phase III trial. Pro Amer Soc Clin Oncol. 23(616A), 2004.
Bradley J, et al. Phase I results of RTOG 0117; A phase I/II dose intensification study using 3DCRTand concurrent chemotherapy for patients with inoperable non-small cell lung cancer. Pro Amer Soc Clin Oncol. 24: p. 7063A, 2005.
Blackstock A. Cancer and Leukemia Group B: Induction plus concurrent chemotherapy with high dose (74 Gy) 3 dimensional (3-D) thoracic radiotherapy in stage III non-small cell lung cancer. Preliminary report of CALGB 30105. Pro Amer Soc Clin Oncol. 24(1): 7042, 2006.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00881712     History of Changes
Other Study ID Numbers: UFPTI 0802-LU02
Study First Received: April 13, 2009
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Non-small cell lung Cancer
Proton Radiation
Stage III

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014