Unknown PHASE2 INTERVENTIONAL 2-arm NCT02288078

Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

A Study of Prophylactic Oral Steroids for Fatigue and Malaise Due to Regorafenib Treatment for Unresectable Metastatic Colorectal Cancer: a Randomized, Placebo-controlled, Double-blind Phase 2 Clinical Study (KSCC1402/HGCSG1402)

Sponsor: Clinical Research Support Center Kyush

Conditions Rectal Cancer

Interventions Adverse event Blood pressure Brain MRI Clinical findings Coagulation and fibrinolysis system Contrast-enhanced torso CT Dexamethasone General condition Hematology/blood chemistry Medication check Patient Reported Outcome Placebo Proton pump inhibitor Regorafenib Thyroid function test Urinalysis

Updated 5 times since 2017 Last updated: Nov 11, 2014 Started: Oct 31, 2014 Primary completion: Sep 30, 2015 Completion: Sep 30, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02288078, this PHASE2 trial focuses on Rectal Cancer and remains ongoing. Sponsored by Clinical Research Support Center Kyush, it has been updated 5 times since 2014, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Unknown PHASE2
Jul 2024 — Sep 2024 [monthly]

Unknown PHASE2

Status: Unknown Status → Unknown
Jan 2021 — Jul 2024 [monthly]

Unknown Status PHASE2
Jun 2018 — Jan 2021 [monthly]

Unknown Status PHASE2
Jan 2017 — Jun 2018 [monthly]

Unknown Status PHASE2

First recorded

Oct 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Clinical Research Support Center Kyush

Data source: Clinical Research Support Center Kyush

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Fukuoka, Japan