Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiation/chemotherapy | Experimental | Hypofractionated radiation：Patients receive accelerated hypofractionated radiation: three-dimensional conformal radiation therapy (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. Chemotherapy: Regimen 1 is as follows: vinorelbine (NVB) was administered by intravenous infusion at a dose of 25 mg/m2 on day 1 (d1) and day 8 (d8), and carboplatin (CBP) is administered at a concentration-time curve (AUC) of 5 mg/ml on d8. This treatment was repeated every 28 days. One cycle of chemotherapy is performed concurrently with the radiotherapy. Chemotherapy: Regimen 2 is as follows: paclitaxel at 30 mg/m2 and cisplatin at 20 mg/m2 (TP) are administrated every week for 5 weeks continuously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiation/chemotherapy | Radiation | Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Progression Free Survival (PFS) at 1 Year | Baseline and 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Qiang Lin, Dr | North China Petroleum Bureau General Hospital of Hebei Medical University | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21351269 | Background | Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. | |
| 25333036 | Background | Chen W, Zheng R, Zhang S, Zhao P, Zeng H, Zou X. Report of cancer incidence and mortality in China, 2010. Ann Transl Med. 2014 Jul;2(7):61. doi: 10.3978/j.issn.2305-5839.2014.04.05. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 28, 2016 | |
| Reset | Nov 17, 2016 | |
| Release | Mar 3, 2021 | |
| Reset | Mar 31, 2021 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 28, 2016 | Nov 17, 2016 | |||
| Mar 3, 2021 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 24373738 | Background | 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. |
| 20351327 | Background | Auperin A, Le Pechoux 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. |
| 16168827 | Background | Kong FM, Ten Haken RK, Schipper MJ, Sullivan MA, Chen M, Lopez C, Kalemkerian GP, Hayman JA. High-dose radiation improved local tumor control and overall survival in patients with inoperable/unresectable non-small-cell lung cancer: long-term results of a radiation dose escalation study. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):324-33. doi: 10.1016/j.ijrobp.2005.02.010. |
| 23957889 | Background | 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. |
| 25601342 | Background | 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. |
| 8567332 | Background | Koukourakis M, Hlouverakis G, Kosma L, Skarlatos J, Damilakis J, Giatromanolaki A, Yannakakis D. The impact of overall treatment time on the results of radiotherapy for nonsmall cell lung carcinoma. Int J Radiat Oncol Biol Phys. 1996 Jan 15;34(2):315-22. doi: 10.1016/0360-3016(95)02102-7. |
| 20423316 | Background | Beli I, Koukourakis G, Platoni K, Tolia M, Kelekis N, Kouvaris J, Syrigos C, Mystakidou K, Varveris C, Kouloulias V. Hypofractionated radiotherapy in non small cell lung cancer: a review of the current literature. Rev Recent Clin Trials. 2010 May;5(2):103-11. doi: 10.2174/157488710791233608. |
| 23584294 | Background | Oh D, Ahn YC, Kim B, Pyo H. Hypofractionated three-dimensional conformal radiation therapy alone for centrally located cT1-3N0 non-small-cell lung cancer. J Thorac Oncol. 2013 May;8(5):624-9. doi: 10.1097/JTO.0b013e31828cb6db. |
| 17078878 | Background | 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. doi: 10.1186/1748-717X-1-42. |
| 22420631 | Background | Amini A, Lin SH, Wei C, Allen P, Cox JD, Komaki R. Accelerated hypofractionated radiation therapy compared to conventionally fractionated radiation therapy for the treatment of inoperable non-small cell lung cancer. Radiat Oncol. 2012 Mar 15;7:33. doi: 10.1186/1748-717X-7-33. |
| 23643277 | Background | McPartlin AJ, Chaudhry S, Swindell R, Bayman N, Burt P, Chittalia A, Cootes J, Faivre Finn C, Harris M, Lander H, Lee L, Sheikh H, Pemberton L. The largest UK single centre series using hypofractionated radical radiotherapy for NSCLC in the very elderly. Lung Cancer. 2013 Jul;81(1):144. doi: 10.1016/j.lungcan.2013.03.010. Epub 2013 May 2. No abstract available. |
| 20056350 | Background | Bral S, Duchateau M, Versmessen H, Engels B, Tournel K, Vinh-Hung V, De Ridder M, Schallier D, Storme G. Toxicity and outcome results of a class solution with moderately hypofractionated radiotherapy in inoperable Stage III non-small cell lung cancer using helical tomotherapy. Int J Radiat Oncol Biol Phys. 2010 Aug 1;77(5):1352-9. doi: 10.1016/j.ijrobp.2009.06.075. Epub 2010 Jan 7. |
| 18986800 | Background | Tho LM, Mahmood R, Leitch M, Brisbane I, Kakumanu S, Mohammed N. Oesophageal toxicity and hypofractionated concurrent chemoradiotherapy for non-small cell lung cancer. Clin Oncol (R Coll Radiol). 2009 Feb;21(1):74. doi: 10.1016/j.clon.2008.10.003. Epub 2008 Nov 5. No abstract available. |
| 25304298 | Background | 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. |
| 25333733 | Background | Kim JO, Chu KP, Fairchild A, Ghosh S, Butts C, Chu Q, Gabos Z, Joy AA, Nijjar T, Robinson DM, Sangha R, Scrimger R, Smylie M, Yee D, Roa WH. Dose-escalated Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy for Inoperable or Unresectable Non-Small Cell Lung Cancer. Am J Clin Oncol. 2017 Jun;40(3):294-299. doi: 10.1097/COC.0000000000000140. |
| 17972527 | Background | Koukourakis MI, Patlakas G, Froudarakis ME, Kyrgias G, Skarlatos J, Abatzoglou I, Bougioukas G, Bouros D. Hypofractionated accelerated radiochemotherapy with cytoprotection (Chemo-HypoARC) for inoperable non-small cell lung carcinoma. Anticancer Res. 2007 Sep-Oct;27(5B):3625-31. |
| 17084621 | Background | Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. doi: 10.1016/j.ejca.2006.09.005. Epub 2006 Nov 3. |
| 24176164 | Background | Bearz A, Minatel E, Rumeileh IA, Borsatti E, Talamini R, Franchin G, Gobitti C, Del Conte A, Trovo 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. |
| 19856048 | Background | 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. |
| 22265460 | Background | 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. |
| 21345508 | Background | Zhu ZF, Fan M, Wu KL, Zhao KL, Yang HJ, Chen GY, Jiang GL, Wang LJ, Zhao S, Fu XL. A phase II trial of accelerated hypofractionated three-dimensional conformal radiation therapy in locally advanced non-small cell lung cancer. Radiother Oncol. 2011 Mar;98(3):304-8. doi: 10.1016/j.radonc.2011.01.022. Epub 2011 Feb 21. |
| 27108080 | Derived | Ren XC, Wang QY, Zhang R, Chen XJ, Wang N, Liu YE, Zong J, Guo ZJ, Wang DY, Lin Q. Accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) combined with concurrent chemotherapy for patients with unresectable stage III non-small cell lung cancer: preliminary results of an early terminated phase II trial. BMC Cancer. 2016 Apr 23;16:288. doi: 10.1186/s12885-016-2314-1. |
| Mar 31, 2021 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |