Challenges and Solutions in the Design and Execution of the PROSPECT Phase II/III Neoadjuvant Rectal Cancer Trial (NCCTG N1048/Alliance)
- Citation:
- Clin Trials vol 16 (2) 165-175
- Year:
- 2019
- Type:
- Manuscript
- Funding:
- NCTN
- Endpoint:
- Secondary-not-in-original
- Analysis:
- Primary
- Data Sharing:
- No-Data-Sharing
- Status:
- Presented/Published
- Citation Status:
- pmc-release
- Note:
- Methodological:
- No
- Biospecimen:
- No
- SDC:
- Yes
- Book Volume:
- 8
- Parents:
- None
- Children:
- None
- Pharmas:
- Grants:
- U10CA180821, U10CA180882, HHS-N261201000063C, U10CA180791, U10CA180838, U10CA180867
- Corr. Author:
- Authors:
- Deborah Schrag Martin Weiser Leonard Saltz Harvey Mamon Marc Gollub Ethan Basch Alan Venook Qian Shi
- Networks:
- CA136, LAPS-MA036, LAPS-NC007, LAPS-NY016
- Study
- NCCTG-N1048
- Multiple Studies, or Legacy Studies in Alliance Study:
- Phases:
- 2/3
- Keywords:
- Locally advanced rectal cancer, neoadjuvant FOLFOX, total mesorectal excision, combined modality treatment, chemoradiation, patient-reported outcomes and symptom burden using PRO-CTCAE, central radiology review of pelvic MRIs, phase II/III hybrid design, co-primary endpoints, pragmatic design elements in cooperative group cancer clinical trials