Randomized Phase II Trial of Induction Chemotherapy Followed by Concurrent Chemotherapy and Dose-Escalated Thoracic Conformal Radiotherapy (74 Gy) in Stage III Non–Small-Cell Lung Cancer: CALGB 30105

Socinski, Mark A.; Blackstock, A. William; Bogart, Jeffrey A.; Wang, Xiaofei; Munley, Michael T.; Rosenman, Julian G.; Gu, Lin; Masters, Gregory A.; Ungaro, Peter C.; Sleeper, A. M.; Green, Mark; Miller, Antonius A.; Vokes, Everett E.

doi:10.1200/jco.2007.14.7371

Cited by 163 publications

(101 citation statements)

References 37 publications

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“…43 Compared with dose-escalated concurrent chemoradiation, the overall RTOG grade !3 late lung toxicity was equal to the 25% reported using CRT. 44 The reported 14% in DCs I, II, and III was in line with a retrospective analysis of IMRT for concurrent chemoradiation that even demonstrated an advantage over CRT. 32 Therefore, we decided that the MTD should be set at 2.24 Gy per fraction.…”

Section: Discussionsupporting

confidence: 67%

Toxicity report of a phase 1/2 dose‐escalation study in patients with inoperable, locally advanced nonsmall cell lung cancer with helical tomotherapy and concurrent chemotherapy

Bral

Duchateau

Versmessen

et al. 2009

Cancer

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BACKGROUND:The objective of the current study was to evaluate the feasibility and toxicity of radiation dose escalation with concurrent chemotherapy using helical tomotherapy (HT) in patients with inoperable, locally advanced, stage III nonsmall cell lung cancer (LANSCLC) (grading determined according to the American Joint Committee on Cancer 6th edition grading system).METHODS:This phase 1/2 study was designed to determine the maximum tolerated dose (MTD) of radiotherapy in patients with LANSCLC administered concurrently with docetaxel and cisplatin. Radiotherapy was delivered using HT. A dose per fraction escalation was applied starting at 2 grays (Gy), with an increase of 6% per dose cohort (DC). The Radiation Therapy Oncology Group acute radiation morbidity score was used to monitor pulmonary, esophageal, and cardiac toxicity.RESULTS:Dose escalation was performed in 34 patients over 5 DCs to a dose per fraction of 2.48 Gy. No differences were observed in acute toxicity between the different DCs. However, a significant increase in late lung toxicity in DC IV, which received a fraction size of 2.36 Gy, necessitated a halt in further dose escalation with the MTD defined as 2.24 Gy per fraction. The overall incidence of acute grade ≥3 esophageal and pulmonary toxicity was 24% and 3%, respectively (grading determined according to the Radiation Therapy Oncology Group‐European Organisation for Research and Treatment of Cancer toxicity scoring system). The overall incidence of late lung toxicity was 21%, but the incidence was an acceptable 13% in DCs I, II, and III. The local response rate was 61% on computed tomography images.CONCLUSIONS:The use of HT to 67.2 Gy with concurrent cisplatin/docetaxel was feasible and resulted in acceptable toxicity. A full phase 2 study has been initiated to establish the true local response rate at the MTD of 2.24 Gy per fraction. Cancer 2010. © 2010 American Cancer Society.

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Section: Discussionsupporting

confidence: 67%

Toxicity report of a phase 1/2 dose‐escalation study in patients with inoperable, locally advanced nonsmall cell lung cancer with helical tomotherapy and concurrent chemotherapy

Bral

Duchateau

Versmessen

et al. 2009

Cancer

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“…In comparison with photons, PBT plans may deliver lower doses to the adjacent organs at risk, such as the esophagus, lungs and bone marrow, thus improving the therapeutic ratio (15). The early clinical outcome of PBT in lung cancer patients (16)(17)(18)(19)(20)(21)(22)(23) demonstrated that proton beam therapy combined with chemotherapy may relatively reduce the rates of toxicity and achieve a possible survival benefit compared with photon beam therapy and 3DCRT (24). Early results (25)(26)(27)(28)(29) suggested that PBT has the advantage of dose escalation, which may prolong patient survival, lower the risk of recurrence and severe toxicity, and intensify chemotherapy (15).…”

Section: Pbt For Different Cancersmentioning

confidence: 99%

The evolution of proton beam therapy: Current and future status (Review)

et al. 2017

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Abstract. Proton beam therapy (PBT) has been increasingly used in a variety of cancers due to its excellent physical properties and superior dosimetric parameters. PBT may improve patient survival by improving the local tumor treatment rate while reducing injury to normal organs, which may result in fewer radiation-induced adverse effects. However, the significant cost of establishing and maintaining proton facilities cannot be overlooked. In addition, there has been significant controversy regarding routine application of this treatment in certain types of cancer. The challenges of PBT in the future mainly include the lack of basic clinical trials, unclear biological effects, immature imaging technology and miniaturization of imaging guidance. Overcoming these limitations may promote the rapid development of PBT. We herein provide an overview of the existing literature on the efficacy and toxicity of common oncological applications of proton beam therapy.

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“…The results of this study encouraged performance of further Phase II studies of concurrent chemoradiotherapy at a dose of 74 Gy. The results of these studies were also favorable with the median survival of 18-37 months and >grade 3 esophagitis and pulmonary toxicity in only 11-17% and 0-30% of the patients, respectively [38][39][40][41][42][43].…”

Section: Clinical Results Of Pbt For Advanced Nsclcmentioning

confidence: 68%

The use of proton-beam therapy in the treatment of non-small-cell lung cancer

Oshiro¹,

Sakurai

2013

Expert Review of Medical Devices

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Randomized Phase II Trial of Induction Chemotherapy Followed by Concurrent Chemotherapy and Dose-Escalated Thoracic Conformal Radiotherapy (74 Gy) in Stage III Non–Small-Cell Lung Cancer: CALGB 30105

Abstract: Arm A reached the primary end point with an estimated MST longer than 18 months and will be compared with a standard dose of TRT in a planned randomized phase III trial in the United States cooperative groups.

Cited by 163 publications

References 37 publications

Toxicity report of a phase 1/2 dose‐escalation study in patients with inoperable, locally advanced nonsmall cell lung cancer with helical tomotherapy and concurrent chemotherapy

Toxicity report of a phase 1/2 dose‐escalation study in patients with inoperable, locally advanced nonsmall cell lung cancer with helical tomotherapy and concurrent chemotherapy

The evolution of proton beam therapy: Current and future status (Review)

The use of proton-beam therapy in the treatment of non-small-cell lung cancer

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