Oxaliplatin Dose Modification for Colorectal Cancer Triggered by Patient Reported Toxicity: Acceptability and Effect on Chronic Chemotherapy Induced Peripheral Neuropathy

Phase 2

Recruiting

• Conditions: metastatic colorectal cancer; chemotherapy induced peripheral neuropathy; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12616001536459
• Lead Sponsor: MidCentral Regional Cancer Treatment Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Male or female patients with histologically proven colorectal adenocarcinoma
* Histological confirmation of metastatic disease or of the primary lesion where an alternative cause for metastatic disease is considered unlikely
2.Unresectable metastatic disease with radiological measurable disease according to RECIST v1.1 on computed tomography (CT)
3.Assessed as suitable for palliative XELOX chemotherapy
4.No contraindications to capecitabine or oxaliplatin chemotherapy
5.Able to complete questionnaires and comply with intervention, assessments and follow-up
6.Written, informed consent

Exclusion Criteria

1.Age < 18 years
2.Patients with a pre-existing neurological condition including established diabetic peripheral neuropathy
3.Patients who have previously been treated with neurotoxic chemotherapy agents including platinums, taxanes and vinka-alkaloids
4.Patients with contra-indications to capecitabine or oxaliplatin

Study & Design

• Study Type: Interventional
• Study Design: Not specified