NCT03666442

Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

Completed Phase 2 Last updated 29 April 2022

What this trial tests

Phase 2 trial testing XELOX in Rectal Cancer in 61 participants. Completed in 1 January 2022.

Timeline

1 June 2018

Primary endpoint
1 January 2020

1 January 2022

Quick facts

Lead sponsor	West China Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	1 June 2018
Primary completion	1 January 2020
Estimated completion	1 January 2022
Sites	1 location across China

Drugs / interventions tested

• XELOX — full drug profile →

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

West China Hospital

Who can join

Adults 20 to 75, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early response to upfront neoadjuvant chemotherapy (CAPOX) alone in low- and intermediate-risk rectal cancer: a single-arm phase II trial.
   Deng X, Wu Q, Bi L, Yu Y, et al · · 2021 · cited 10× · PMID 34792107 · DOI 10.1093/bjs/znab388