Randomised phase III study of docetaxel versus active symptom control in patients with relapsed gastric adenocarcinoma

Phase 3

Completed

• Conditions: Advanced gastric cancer; Cancer; Gastric cancer

• Registration Number: ISRCTN13366390
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24332238

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-14
• Study Completion: 2010-10-10
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Patients with histologically confirmed adenocarcinoma of the stomach (including Siewert-Stein type II and III adenocarcinoma of the oesophago-gastric junction)
2. Age 18 years or older
3. Advanced disease not amenable to curative treatment
4. Documented progressive disease while receiving or within 6 months of completion of first line chemotherapy with a platinum and fluoropyrimidine based therapy either for advanced disease or as neoadjuvant/perioperative therapy
5. Estimated life expectancy greater than or equal to 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
7. Satisfactory haematologic (haemoglobin [Hb] greater than or equal to 10 g/dL, White Blood Cells [WBC] greater than or equal to 3.0 x 10^9/L, Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^9/L, Platelets (Plt) greater than or equal to 100 x10^9/L), renal (creatinine less than or equal to Upper Limit of Normal [ULN]) and hepatic (total Bilirubin less than or equal to ULN, Alanine aminotransferase (ALT) less than or equal to 1.5 x ULN, Alkaline Phosphatase (ALP) less than or equal to 5 x ULN) function
8. Ability to give informed consent
9. Completion of baseline questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and EORTC-QLQ-STO22 [gastric cancer-specific QLQ] and EuroQoL (EQ-5D) questionnaire)
10. Patients of both sexes with reproductive potential must be willing to employ barrier contraceptives whilst on treatment and for 3 months after completion of treatment

Exclusion Criteria

1. Cerebral or leptomeningeal metastasis
2. Prior chemotherapy with taxanes
3. Peripheral neuropathy
4. More than one prior chemotherapy regimen in advanced setting
5. Previous malignancy except for curatively treated basal cell carcinoma of the skin or cervical intraepithelial neoplasia
6. Pregnant or breastfeeding female patient
7. Any medical or psychiatric condition which would influence the ability to provide informed consent
8. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified