drugset / Trial / NCT03280407

NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer

NCT03280407 ↗

Phase 2 Unknown 124 enrolled Zealand University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local relapse. The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery Furthermore, early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided. Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.

Timeline

Start
2017-03-01
Primary completion
2018-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 825 mg/m2 —
Comparator Capecitabine Small molecule 1000 mg/m2 —
Subject Leucovorin Small molecule 400 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject fluorouracil Small molecule 400 mg/m2 —
Subject fluorouracil Small molecule 2400 mg/m2 —

Indications