Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus; Cancer; Malignant neoplasm of oesophagus

• Registration Number: ISRCTN44687907
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

2019 Abstract results in https://doi.org/10.1093/annonc/mdz394.037 quality of life results presented at ESMO (added 04/02/2020) 2019 Abstract results in https://doi.org/10.1200/JCO.2019.37.15_suppl.4006 results presented at ASCO (added 04/02/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33983395/ (added 17/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-10
• Study Completion: 2018-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

1. Histologically or cytologically confirmed carcinoma of the oesophagus, GO junction or stomach
2. With or without distant metastases, but if M0, being treated with palliative intent
3. Considered by the treating physician to be fit/suitable for any of the GO2 regimens.
4. Renal function: estimated or measured GFR >=30 ml/min (if in the range 3050ml/min, reduced doses of both drugs must be used)
5. Hepatic function: bilirubin <3 times upper limit of normal (xULN) (if in the range 1.53xULN, reduced doses of both drugs must be used)
6. Bone marrow function: absolute neutrophil count >=1.5 x10^9/l; white blood cell count >=3 x10^9/l; platelets >=100 x10^9/l.
7. Written informed consent
8. Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Fit, suitable (as judged by the treating clinician) and willing for standard full dose combination chemotherapy with EOX or equivalent
2. Previous palliative chemotherapy for GO cancer
3. Medical or psychiatric condition impairing ability to consent or comply with oral chemotherapy or trial assessments (including patient reported outcome measures)
4. Other malignancy if, in the opinion of the treating physician, this would significantly impede interpretation of the outcome of the trial treatment
5. Age <18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified