Evaluating the potential benefit of adjuvant chemotherapy for small bowel a... | Recruiting
Evaluating the potential benefit of... | Recruiting
Evaluating the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma
BALLAD

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Medical Conditions
  • Small bowel adenocarcinoma
Primary Contact Details
Mrs Judith Dixon-Hughes
0141 301 7540
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN15070952
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
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-after-surgery-for-small-bowel-cancer-ballad
Research Details
  • Adjuvant fluoropyrimidine chemotherapy results in an improved outcome (DFS and OS) over observation alone after potentially curative surgery for stage I, II and III SBA2. Adjuvant fluoropyrimidine and oxaliplatin chemotherapy results in an improved outcome (DFS and OS) over fluropyrimidine alone after potentially curative surgery for stage I, II and III small bowel adenocarcinoma.
Phase
Phase III
Study Design
Open-label randomised controlled multi-centre global trial
Study Type
Interventional
Intervention

Group 1: Patients will be randomised between observation and chemotherapy. Those patients who draw the chemotherapy arm and who have consented to this can go on to be randomised into the group 2 question. This is to be encouraged as it will add significant value and improve efficiency of the trial.
Group 2: Patients will be randomised to receive therapy with a fluoropyrimidine regimen or combination therapy of fluoropyrimidine plus oxaliplatin. Investigators must specify the fluoropyrimidine regimen at the time of randomisation for each individual patient. Any accepted institutional standard IV 5-FU/Folinic Acid regimen or oral capecitabine regimen may be used. The combination regimen is specified as oxaliplatin delivered as part of a standard institutional fluoropyrimidine combination regimen. Treatment will continue for up to 24 weeks

Intervention Type
Drug
Primary Outcome Measures
    Disease free survival is the primary end point for the trial. This is defined at time from randomisation to the first occurrence of the following events:
    1. Disease relapse (confirmed by imaging)
    2. Incidence of a new primary (confirmed by imaging and histology/cytology)
    3. Death from any cause
    Patients who experience none of these events are censored at the last date known to be alive.
Secondary Outcome Measures
    1. Overall survival: The patient’s survival status is determined at each follow-up visit. After the mandated clinic visits survival status data will come from responsible cancer centres, cancer registries and national databases and include long-term passive follow-up data such as that collected through collaboration with the National Cancer Intelligence Network in the U.K.
    2. Toxicity of chemotherapy: Toxicity will be assessed using CTCAE version 4.0. Only toxicities that are at least grade 2 will be recorded on the CRF
    3. Quality of life: This is assessed using the EORTC QLQ-C30, EORTC QLQ-CR29 v2.1 and EQ-5D scales
    Health Economics: Assess the cost-effectiveness of 24 weeks adjuvant chemotherapy in comparison to observation alone; and assess the cost-effectiveness of 24 weeks adjuvant 5FU/Capecitabine monotherapy compared to 5FU/Capecitabine plus Oxaliplatin. Outcomes will be reported as incremental cost per DFS and incremental cost per QALY. 4. Establishment of a central tissue bank for patients with SBA
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
880
Participant Inclusion Criteria
    1. R0 resected stage I, II or III SBA
    2. No evidence of residual or metastatic disease at laparotomy or on CT/MRI imaging of chest, abdomen and pelvis
    3. Patients must be registered and randomised within 12 weeks of surgery and commence chemotherapy within 14 weeks of surgery
    4. ECOG Performance Status of 0 or 1
    5. Absolute neutrophil account ≥ 1.5 x109/l
    6. Platelet count ≥ 100 x 109/l
    7. Haemoglobin ≥90 g/l (previous transfusion is allowed)
    8. AST and ALT ≤ 2.5 x upper limit of normal (ULN). (At least one of ALT or AST MUST be performed)
    9. Creatinine clearance > 50 ml/min (calculated by Cockcroft Gault or Wright equation) or measured by EDTA
    10. Serum bilirubin ≤ 1.5 x ULN
    11. Signed and dated informed consent indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment
    12. Age ≥ 16 years
    13. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
Participant Exclusion Criteria
    1. Non-adenocarcinoma histology of small bowel tumour which includes but is not confined to lymphoma, GIST, carcinoid or other neuroendocrine tumour, squamous carcinoma, melanoma or sarcoma
    2. Previous neo-adjuvant chemo(radio)therapy for SBA
    3. Clinically significant cardiovascular disease (i.e. active or < 12 months since cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association [NYHA] grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension)
    4. Pregnancy/lactation or of child bearing potential and not using medically approved contraception. (Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
    5. Previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 3 years and treatment was with curative intent
    6. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
    7. Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction
    8. Grade ≥ 2 peripheral neuropathy
    9. Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment
    10. Previous hypersensitivity to platinum salts
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)
-
Trial Contact(s)
Primary Trial Contact
Mrs Judith Dixon-Hughes
0141 301 7540
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
France, Japan, 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
A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma
EudraCT Number
2013-003047-29
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
BALLAD 2013
Sponsor(s)
Greater Glasgow and Clyde Healthboard and University of Glasgow
Key Dates

Recruitment Start Date

01 Mar 2015

Recruitment End Date

01 Mar 2020

Trial Start Date

01 Mar 2015

Trial End Date

30 Aug 2022

Date added to source

16 Dec 2014

Date updated in source

05 Apr 2016