NCT00881712 — Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02) · CancerIndex
Clinical trial · Interventional
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
Why stopped (as posted): projected enrollment rate not feasible
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
PET positive nodal disease measuring 15 mm or greater
Radiation
—
UNRESOLVED
PET positive nodal disease measuring less than 15 mm
Radiation
—
UNRESOLVED
Design
Arms and outcomes
Arms (3)
type
EXPERIMENTAL
label
PET positive nodal disease measuring 15 mm or greater
description
Proton radiation with concomitant chemotherapy
interventionNames
Radiation: PET positive nodal disease measuring 15 mm or greater
type
EXPERIMENTAL
label
PET positive nodal disease measuring less than 15 mm
description
Proton radiation
interventionNames
Radiation: PET positive nodal disease measuring less than 15 mm
type
EXPERIMENTAL
label
Patients considered resectable
description
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
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.
References
Publications (26)
BACKGROUNDCancer Facts and Figures 2008 - American Cancer Society http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf
BACKGROUNDDelaney, Kooy editors: Proton and Charged particle Radiotherapy; LWW, 2008
BACKGROUNDChang JY, Zhang X, Wang X, Kang Y, Riley B, Bilton S, Mohan R, Komaki R, Cox JD. Significant reduction of normal tissue dose by proton radiotherapy compared with three-dimensional conformal or intensity-modulated radiation therapy in Stage I or Stage III non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1087-96. doi: 10.1016/j.ijrobp.2006.01.052. Epub 2006 May 6. PMID 16682145
BACKGROUNDAuberger T, Seydl K, Futschek T, Sztankay A, Sweeney RA, Lukas P. Photons or protons: precision radiotherapy of lung cancer. Strahlenther Onkol. 2007 Dec;183 Spec No 2:3-6. doi: 10.1007/s00066-007-2002-9. No abstract available. PMID 18166995
BACKGROUNDNichols 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
BACKGROUNDGraham MV, Purdy JA, Emami B, Harms W, Bosch W, Lockett MA, Perez CA. Clinical dose-volume histogram analysis for pneumonitis after 3D treatment for non-small cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):323-9. doi: 10.1016/s0360-3016(99)00183-2. PMID 10487552
BACKGROUNDLee HK, Vaporciyan AA, Cox JD, Tucker SL, Putnam JB Jr, Ajani JA, Liao Z, Swisher SG, Roth JA, Smythe WR, Walsh GL, Mohan R, Liu HH, Mooring D, Komaki R. Postoperative pulmonary complications after preoperative chemoradiation for esophageal carcinoma: correlation with pulmonary dose-volume histogram parameters. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1317-22. doi: 10.1016/s0360-3016(03)01373-7.
Proton radiation plus surgery
interventionNames
Radiation: Patients considered resectable
Primary outcomes (1)
measure
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
timeFrame
Six months after end of radiation therapy
Secondary outcomes (4)
measure
Percentage of Patients With Disease Control
timeFrame
Following treatment every 6 months for 2 years, then annually for 4 years.
description
Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."), as accurate.
measure
Percentage of Patients Alive at 5 Years
timeFrame
Five years following radiation treatment
measure
Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy
timeFrame
Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually
measure
Correlation of Functional CT-PET Imaging With Treatment Outcomes
timeFrame
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
BACKGROUNDKomaki 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.
BACKGROUNDCurran 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).
BACKGROUNDFuruse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692. PMID 10561343
BACKGROUNDRosenzweig KE, Sim SE, Mychalczak B, Braban LE, Schindelheim R, Leibel SA. Elective nodal irradiation in the treatment of non-small-cell lung cancer with three-dimensional conformal radiation therapy. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):681-5. doi: 10.1016/s0360-3016(01)01482-1. PMID 11395236
BACKGROUNDMartel 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.
BACKGROUNDNichols RC, Huh SN, Hoppe BS, Henderson RH, Li Z, Mendenhall NP. Protons Safely Allow Coverage of High Risk Nodes for Patients with Regionally Advanced NSCLC, University of Florida Proton Therapy Institute. Submitted for consideration. American Radium Society, 2009.
BACKGROUNDRosenman JG, Halle JS, Socinski MA, Deschesne K, Moore DT, Johnson H, Fraser R, Morris DE. High-dose conformal radiotherapy for treatment of stage IIIA/IIIB non-small-cell lung cancer: technical issues and results of a phase I/II trial. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):348-56. doi: 10.1016/s0360-3016(02)02958-9. PMID 12243807
BACKGROUNDPerez CA, Pajak TF, Rubin P, Simpson JR, Mohiuddin M, Brady LW, Perez-Tamayo R, Rotman M. Long-term observations of the patterns of failure in patients with unresectable non-oat cell carcinoma of the lung treated with definitive radiotherapy. Report by the Radiation Therapy Oncology Group. Cancer. 1987 Jun 1;59(11):1874-81. doi: 10.1002/1097-0142(19870601)59:113.0.co;2-z. PMID 3032394
BACKGROUNDFletcher GH. Clinical dose-response curves of human malignant epithelial tumours. Br J Radiol. 1973 Jan;46(541):1-12. doi: 10.1259/0007-1285-46-541-1. No abstract available. PMID 4630323
BACKGROUNDAlbain 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.
BACKGROUNDLau D, Leigh B, Gandara D, Edelman M, Morgan R, Israel V, Lara P, Wilder R, Ryu J, Doroshow J. Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: a California Cancer Consortium phase II trial. J Clin Oncol. 2001 Jan 15;19(2):442-7. doi: 10.1200/JCO.2001.19.2.442. PMID 11208837
BACKGROUNDChoy H, Akerley W, Safran H, Graziano S, Chung C, Williams T, Cole B, Kennedy T. Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J Clin Oncol. 1998 Oct;16(10):3316-22. doi: 10.1200/JCO.1998.16.10.3316. PMID 9779707
BACKGROUNDVokes 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.
BACKGROUNDBradley 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.
BACKGROUNDBlackstock 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.
BACKGROUNDRoth JA, Atkinson EN, Fossella F, Komaki R, Bernadette Ryan M, Putnam JB Jr, Lee JS, Dhingra H, De Caro L, Chasen M, Hong WK. Long-term follow-up of patients enrolled in a randomized trial comparing perioperative chemotherapy and surgery with surgery alone in resectable stage IIIA non-small-cell lung cancer. Lung Cancer. 1998 Jul;21(1):1-6. doi: 10.1016/s0169-5002(98)00046-4. PMID 9792048
BACKGROUNDBelani CP, Choy H, Bonomi P, Scott C, Travis P, Haluschak J, Curran WJ Jr. Combined chemoradiotherapy regimens of paclitaxel and carboplatin for locally advanced non-small-cell lung cancer: a randomized phase II locally advanced multi-modality protocol. J Clin Oncol. 2005 Sep 1;23(25):5883-91. doi: 10.1200/JCO.2005.55.405. Epub 2005 Aug 8. PMID 16087941
BACKGROUNDChvetsov AV, Palta JJ, Nagata Y. Time-dependent cell disintegration kinetics in lung tumors after irradiation. Phys Med Biol. 2008 May 7;53(9):2413-23. doi: 10.1088/0031-9155/53/9/013. Epub 2008 Apr 17. PMID 18421118
BACKGROUNDChapet O, Kong FM, Quint LE, Chang AC, Ten Haken RK, Eisbruch A, Hayman JA. CT-based definition of thoracic lymph node stations: an atlas from the University of Michigan. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):170-8. doi: 10.1016/j.ijrobp.2004.12.060. PMID 16111586