Results of a Multicentric In Silico Clinical Trial (ROCOCO): Comparing Radiotherapy with Photons and Protons for Non-small Cell Lung Cancer

Roelofs, Erik; Engelsman, Martijn; Rasch, Coen R. N.; Persoon, L.; Qamhiyeh, Sima; Ruysscher, Dirk De; Verhaegen, Frank; Pijls‐Johannesma, Madelon

doi:10.1097/jto.0b013e31823529fc

Cited by 89 publications

(58 citation statements)

References 59 publications

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“…gov/show/NCT01255748) have proceeded. In silico trials, such as those from the rococo consortium 88 , could help to guide clinical trial development.…”

Section: Discussionmentioning

confidence: 99%

Recommendations for the Referral of Patients for Proton-Beam Therapy, an Alberta Health Services Report: A Model for Canada?

et al. 2014

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able and willing to travel abroad to a proton facility. Commonly accepted indications for referral include chordoma and chondrosarcoma, intraocular melanoma, and solid tumours in children and adolescents who have the greatest risk for long-term sequelae. Current data do not provide sufficient evidence to recommend routine referral of patients with most head-and-neck, breast, lung, gastrointestinal tract, and pelvic cancers, including prostate cancer. It is recommended that all referrals be considered by a multidisciplinary team to select appropriate cases.

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“…gov/show/NCT01255748) have proceeded. In silico trials, such as those from the rococo consortium 88 , could help to guide clinical trial development.…”

Section: Discussionmentioning

confidence: 99%

Recommendations for the Referral of Patients for Proton-Beam Therapy, an Alberta Health Services Report: A Model for Canada?

et al. 2014

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“…Neither induction nor consolidation chemotherapy have shown better outcomes. 29,30 Both improvement of local control by more sophisticated RT 31 and prevention of metastasis by systemic therapy are important. As the addition of cetuximab to intensified, accelerated RT and cisplatin–vinorelbine did not show DLT, this strategy, possibly strengthened by EGFR imaging or specific molecular markers, may be further pursued.…”

Section: Discussionmentioning

confidence: 99%

A Phase I Study of Concurrent Individualized, Isotoxic Accelerated Radiotherapy and Cisplatin–Vinorelbine–Cetuximab in Patients With Stage III Non–Small-Cell Lung Cancer

Dingemans

Bootsma

Baardwijk

et al. 2014

Journal of Thoracic Oncology

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Background:In this open-label phase I study, the maximum-tolerated dose of cetuximab with concurrent chemoradiotherapy (C-CRT) in stage III non–small-cell lung cancer together with individualized, isotoxic accelerated radiotherapy (RT) was investigated.Methods:Patients with stage III non–small-cell lung cancer, World Health Organization performance status 0–1, forced expiratory volume in 1 second more than 50%, carbon monoxide diffusing capacity more than 50%, weight loss less than 10%, and no severe comorbidity were enrolled. Patients without progression after one to two cycles of gemcitabine–carboplatin were included and treated with cetuximab 400 mg/kg d7 and 250 mg/kg weekly together with RT and cisplatin (50 mg/m2 d1, 8; 40 mg/m2 d22)–vinorelbine for 5 weeks. Vinorelbine was escalated in three steps; (1) 10 mg/m2 d1, 8 and 8 mg/m2 d22, 29; (2) 20 mg/m2 d1, 8 and 8 mg/m2 d22, 29; (3) 20 mg/m2 d1, 8; 15 mg/m2 d22, 29. An individualized prescribed RT dose based on normal tissue dose constraints was applied (e.g., mean lung dose 19 Gy). The primary endpoint was the maximum-tolerated dose 3 months after the end of C-CRT; secondary endpoints were toxicity and metabolic response as assessed by positron emission tomography.Results:Between September 2007 and October 2010, 25 patients (12 men, 13 women, mean age 59 years) were included. The mean RT dose was 62 ± 6.6 Gy. The vinorelbine dose could be escalated to dose level 3. Twelve of 25 patients experienced greater than or equal to grade 3 toxicity (esophagitis 3, rash 1, diarrhea 1, cough 1, dyspnea 1, vomiting 1, and pulmonary embolism 1). No dose-limiting toxicities were observed. One patient with a complete pathological response in dose level 3 developed a fatal hemoptysis 4 months after RT. Metabolic remissions were observed in 19 of 22 patients.Conclusion:C-CRT with cetuximab and cisplatin–vinorelbine is safe to deliver at full dose. The recommended phase II dose is therefore cetuximab 400 mg/m2 d7 and 250 mg/m2 weekly, cisplatin 50 mg/m2 d1, 8; 40 mg/m2 d22 and vinorelbine 20 mg/m2 d1, 8; 15 mg/m2 d22, 29 for 5 weeks together with RT.

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“…Few studies have compared the dose distribution between proton and photon beams for stage III NSCLC compared with those for early stage NSCLC, however, the advantage of PBT for stage III NSCLC seems to be more significant than that for early NSCLC [49,50]. Roelofs et al investigated if PBT reduces the dose and irradiated volume of normal tissue with dose escalation in 25 patients with stage IA-IIIB disease, including 20 cases of stage IIB-IIIB disease [49].…”

Section: Clinical Results Of Pbt For Advanced Nsclcmentioning

confidence: 99%

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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Results of a Multicentric In Silico Clinical Trial (ROCOCO): Comparing Radiotherapy with Photons and Protons for Non-small Cell Lung Cancer

Cited by 89 publications

References 59 publications

Recommendations for the Referral of Patients for Proton-Beam Therapy, an Alberta Health Services Report: A Model for Canada?

Recommendations for the Referral of Patients for Proton-Beam Therapy, an Alberta Health Services Report: A Model for Canada?

A Phase I Study of Concurrent Individualized, Isotoxic Accelerated Radiotherapy and Cisplatin–Vinorelbine–Cetuximab in Patients With Stage III Non–Small-Cell Lung Cancer

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

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