Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Study of Accelerated Hypofractionated Three-dimensional Conformal Radiation Therapy Concurrent With Chemotherapy in Unresectable Stage III Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720614
• Other study ID #: NorthChinaPBGH
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2016
• Last updated: March 25, 2016
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: North China Petroleum Bureau General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.

Description:

Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.

Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer

• The Karnofsky performance status (KPS) score =70.

• The expected survival time =3 months.

• Adequate blood, liver, lungs and kidney function

• Accessible contact information

• Informed consent required before enrollment.

Exclusion Criteria:

• Pregnant or breastfeeding.

• Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years)

• Cannot receive concurrent chemotherapy due to medical reasons.

• Superior vena cava syndrome.

• Severe lung diseases that affected lung function.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• Hypofractionated radiation/chemotherapy
Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LIN QIANG

References & Publications (23)

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Aupérin A, Le Péchoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29. Review. — View Citation

Bayman N, Blackhall F, McCloskey P, Taylor P, Faivre-Finn C. How can we optimise concurrent chemoradiotherapy for inoperable stage III non-small cell lung cancer? Lung Cancer. 2014 Feb;83(2):117-25. doi: 10.1016/j.lungcan.2013.11.017. Epub 2013 Dec 1. Review. — View Citation

Bearz A, Minatel E, Rumeileh IA, Borsatti E, Talamini R, Franchin G, Gobitti C, Del Conte A, Trovò M, Baresic T. Concurrent chemoradiotherapy with tomotherapy in locally advanced Non-Small Cell Lung Cancer: a phase I, docetaxel dose-escalation study, with hypofractionated radiation regimen. BMC Cancer. 2013 Oct 31;13:513. doi: 10.1186/1471-2407-13-513. — View Citation

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Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16. — View Citation

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Faria SL, Souhami L, Portelance L, Duclos M, Vuong T, Small D, Freeman CR. Absence of toxicity with hypofractionated 3-dimensional radiation therapy for inoperable, early stage non-small cell lung cancer. Radiat Oncol. 2006 Nov 1;1:42. — View Citation

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Lin Q, Liu YE, Ren XC, Wang N, Chen XJ, Wang DY, Zong J, Peng Y, Guo ZJ, Hu J. Dose escalation of accelerated hypofractionated three-dimensional conformal radiotherapy (at 3 Gy/fraction) with concurrent vinorelbine and carboplatin chemotherapy in unresectable stage III non-small-cell lung cancer: a phase I trial. Radiat Oncol. 2013 Aug 17;8(1):201. doi: 10.1186/1748-717X-8-201. — View Citation

Maguire J, Khan I, McMenemin R, O'Rourke N, McNee S, Kelly V, Peedell C, Snee M. SOCCAR: A randomised phase II trial comparing sequential versus concurrent chemotherapy and radical hypofractionated radiotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer and good performance status. Eur J Cancer. 2014 Nov;50(17):2939-49. doi: 10.1016/j.ejca.2014.07.009. Epub 2014 Oct 7. — View Citation

Matsuura K, Kimura T, Kashiwado K, Fujita K, Akagi Y, Yuki S, Murakami Y, Wadasaki K, Monzen Y, Ito A, Kagemoto M, Mori M, Ito K, Nagata Y. Results of a preliminary study using hypofractionated involved-field radiation therapy and concurrent carboplatin/paclitaxel in the treatment of locally advanced non-small-cell lung cancer. Int J Clin Oncol. 2009 Oct;14(5):408-15. doi: 10.1007/s10147-009-0889-0. Epub 2009 Oct 25. — View Citation

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Ohri N, Dicker AP, Lawrence YR. Can drugs enhance hypofractionated radiotherapy? A novel method of modeling radiosensitization using in vitro data. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):385-93. doi: 10.1016/j.ijrobp.2011.06.1990. Epub 2012 Jan 19. Review. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Severe and Life-threatening Adverse Events (AE)	intolerable toxicities: severe and life-threatening adverse events (Grade III/IV in Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3.0))	Baseline to the time of intolerable toxicity(up to 1 year) or measured Progressive Disease (PD)
Secondary	Percentage of Participants with Progression Free Survival (PFS) at 1 Year		Baseline and 1 year