Platinum and etoposide chemotherapy, durvalumab with thoracic radiotherapy in the first-line treatment of patients with extensive-stage small-cell lung cancer: CHEST-RT (TROG 20.01) Trial – protocol for a phase II study
Year: 2025
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer. METHODS: A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT). ETHICS AND DISSEMINATION: This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).
Source: BMJ Open
Authors: Sagun Parakh, Harriet Gee, Adeline Lim, Shalini Vinod, Courtney Wheeler, Bridget Rooney, Rebecca Montgomery, Susan Harden, Melissa Moore, Margot Lehman, Catherine Bettington, Trevor Moodie, Jeffrey Barber, Laurel Schmidt, Jason Dizon, Lucy Leigh, Christopher Oldmeadow, Paul Mitchell, Eric Hau
Institutions: Austin Hospital, Olivia Newton-John Cancer Wellness & Research Centre, Austin Health, The University of Sydney, Children's Medical Research Institute, Western Sydney Local Health District, Liverpool Hospital, UNSW Sydney, Trans Tasman Radiation Oncology Group, The University of Melbourne, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, St Vincent's Hospital Melbourne, The University of Queensland, Princess Alexandra Hospital, Royal Brisbane and Women's Hospital, Westmead Hospital, Blacktown & Mount Druitt Hospital, Hunter Medical Research Institute, University of Newcastle Australia, Olivia Newton-John Cancer Research Institute, Westmead Institute for Medical Research
Language: English
Topic: Lung Cancer Research Studies
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
Funder: AstraZeneca
Award: G3253266293
OpenAlex ID: W4412077970