Understanding Heterogeneity in the Classification of Locally Advanced Cancer: Analysis of Clinical Trial Records From the Past 2 Years (2023-2025)
Author(s)
Tess Moore, BSc, MSc, Rhian Kilty, BSc, Grace G Goldsmith-Martin, PhD, Angaja Phalguni, PhD.
Genesis Research Group, London, United Kingdom.
Genesis Research Group, London, United Kingdom.
OBJECTIVES: Consistent definition of locally advanced cancers in trial records would aid the screening process and potentially reduce bias in systematic literature reviews. We analysed reporting of staging for locally advanced cancer in recent trial registration records to identify frequency of comprehensive reporting.
METHODS: Clinicaltrials.gov was searched for phase II/III trials including adult patients with locally advanced cancer (records available between April 2023-2025). All cancer types were eligible. Records including more than one cancer type, multiple solid tumours or not differentiating locally advanced from metastatic cancers were excluded.
RESULTS: Overall, 33 cancer types were identified in 507 clinical-trial records. The seven most-reported cancers (lung, gastric, rectal, oesophageal, breast, pancreatic, and cervical) reported in ≥20 trial records (n=379) were analysed. Forty percent of records did not report any staging reference or system to identify locally advanced cancer (40.9%). A quarter (27.7%) reported only Tumor, Node, Metastasis (TNM) staging (17.4%), numerical staging (7.9%), or both in combination (2.4%) without detail of their reference source. The most frequently reported staging system was the American Joint Committee on Cancer (AJCC), either alone (17.9%) or with Union for International Cancer Control (UICC) (2.9%). Tumor-specific staging systems were reported in 8.9% of records and included International Association for the Study of Lung Cancer (IASLC), the International Federation of Gynaecology and Obstetrics (FIGO), Chinese Society of Clinical Oncology, National Comprehensive Cancer Network (NCCN) guidelines for pancreatic cancer, and European Society for Medical Oncology (ESMO) guidelines for rectal cancer. Records of cervical cancer were most likely to report staging criteria (86%), least likely were pancreatic cancer (12%) and breast cancer (20%).
CONCLUSIONS: Phase II/III cancer-trial records often fail to report or report-poorly the staging criteria for locally advanced cancers. Improving reporting would assist systematic reviewers to correctly identify trials and potentially reduce bias and time taken to screen trials.
METHODS: Clinicaltrials.gov was searched for phase II/III trials including adult patients with locally advanced cancer (records available between April 2023-2025). All cancer types were eligible. Records including more than one cancer type, multiple solid tumours or not differentiating locally advanced from metastatic cancers were excluded.
RESULTS: Overall, 33 cancer types were identified in 507 clinical-trial records. The seven most-reported cancers (lung, gastric, rectal, oesophageal, breast, pancreatic, and cervical) reported in ≥20 trial records (n=379) were analysed. Forty percent of records did not report any staging reference or system to identify locally advanced cancer (40.9%). A quarter (27.7%) reported only Tumor, Node, Metastasis (TNM) staging (17.4%), numerical staging (7.9%), or both in combination (2.4%) without detail of their reference source. The most frequently reported staging system was the American Joint Committee on Cancer (AJCC), either alone (17.9%) or with Union for International Cancer Control (UICC) (2.9%). Tumor-specific staging systems were reported in 8.9% of records and included International Association for the Study of Lung Cancer (IASLC), the International Federation of Gynaecology and Obstetrics (FIGO), Chinese Society of Clinical Oncology, National Comprehensive Cancer Network (NCCN) guidelines for pancreatic cancer, and European Society for Medical Oncology (ESMO) guidelines for rectal cancer. Records of cervical cancer were most likely to report staging criteria (86%), least likely were pancreatic cancer (12%) and breast cancer (20%).
CONCLUSIONS: Phase II/III cancer-trial records often fail to report or report-poorly the staging criteria for locally advanced cancers. Improving reporting would assist systematic reviewers to correctly identify trials and potentially reduce bias and time taken to screen trials.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
SA99
Topic
Study Approaches
Topic Subcategory
Literature Review & Synthesis
Disease
Oncology