Alternative chemotherapy for frail or elderly patients with advanced gastri... | Not Recruiting
Alternative chemotherapy for frail ... | Not Recruiting
Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer
GO2

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Upper Gastro-Intestinal Cancer
  • Disease: Oesophagus
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN44687907
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-at-chemotherapy-for-frail-or-elderly-patients-with-advanced-cancer-of-the-stomach-or-food-pipe-go2
Research Details
  • The GO2 study is a randomised controlled trial (RCT) of palliative chemotherapy using oxaliplatin and capecitabine (OxCap) in frail/elderly patients with advanced GO cancer who are not fit to receive standard full-dose chemotherapy, but who are suitable for lower-dose chemotherapy. The trial will compare 3 dose levels of OxCap chemotherapy and a best supportive care (BSC) arm.

    The aims of doing this study are:
    1. To find out which dose of OxCap achieves the best balance of cancer control,toxicity, patient acceptability and quality of life for frailer patients with advanced cancer of the gullet or stomach.
    2. To find out if there are any patient characteristics that could predict better orworse outcomes with chemotherapy at different doses.
    3. To find out whether there is any benefit to giving chemotherapy to patients for whom there is substantial uncertainty about the role of chemotherapy.

    Eligible and consenting participants will undergo a Comprehensive Health Assessment (CHA). Patients considered likely to benefit from chemotherapy will be randomised to receive one of three dose intensities of OxCap. Patients considered as uncertain to benefit from chemotherapy will be randomised to one of the three dose intensities of OxCap or a BSC arm.

    GO2 aims to recruit a minimum of 500 patients across the UK over a 3 year period. It will provide the first RCT evidence to guide the use of palliative chemotherapy in elderly/frail patients with advanced GO cancer, and has the potential to have significant impact upon clinical practice.
Phase
Phase III
Study Design
Randomised interventional treatment trial
Study Type
Interventional
Intervention

GO2 has no fixed sample size. The trial aims to recruit a minimum of 500 participants to the chemotherapy arms, and an additional 30 participants to the BSC arm over 3 years. However, should accrual rates exceed expectations and 750 participants be recruited prior to 3 years. trial closure would then be considered.

Best supportive care (BSC): Participants randomised to receive best supportive care (BSC) will be treated according to local policy.
OxCap 100%: Oxaliplatin 130mg/m^2 day 1 Capecitabine 625mg/m^2 bd x 21 days
OxCap 80%: Oxaliplatin 104mg/m^2 day 1 Capecitabine 500mg^m2 bd x 21 days
OxCap 60%: Oxaliplatin 78mg/m^2 day 1 Capecitabine 375mg/m^2 bd x 21 days

Follow Up Length: 12 months

Study Entry : Single Randomisation only

Intervention Type
Other
Primary Outcome Measures
    Chemotherapy intensity comparison:
    1. Progression free survival

    Chemotherapy vs best supportive care comparison
    1. Overall survival
Secondary Outcome Measures
    Chemotherapy intensity comparison:
    1. Participant reported fatigue
    2. Time to deterioration of participant reported fatigue
    3. Overall treatment utility
    4. Quality of life and symptoms
    5. Toxicity
    6. Overall survival
    7. Quality adjusted survival
    8. Best response

    Chemotherapy vs best supportive care comparison:
    1. Participant reported fatigue
    2. Quality of life


    Comprehensive Health Assessment (CHA) – pre-randomisation
    EQ-VAS – weekly until week 18
    Short follow-up questionnaire – 3-weekly until week 18, then weeks 27, 36 and 52
    Limited Health Assessment – week 9
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 780; UK Sample Size: 780
Participant 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
Participant 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Leeds
LS2 9JT
-
Trial Contact(s)
Primary Trial Contact
Mrs Sharon Ruddock
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
GO2 - Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer: a randomised controlled trial
EudraCT Number
2013-000009-21
Funder(s)
  • Cancer Research UK (UK)
Other Study ID Numbers
15037
Sponsor(s)
University of Leeds (UK)
Key Dates

Recruitment Start Date

08 Jan 2014

Recruitment End Date

31 Oct 2017

Trial Start Date

01 Sep 2013

Trial End Date

31 Dec 2018

Date added to source

10 Sep 2013

Date updated in source

10 Aug 2017