BALLAD- a trial to evaluate the potential benefit of adjuvant chemotherapyfor small bowel adenocarcinoma

Phase 1

• Conditions: Small Bowel Adenocarcinoma; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003047-29-DK
• Lead Sponsor: Greater Glasgow and Clyde Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

1.R0 resected stage I, II or III small bowel adenocarcinoma
2.No evidence of residual or metastatic disease at laparotomy and 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 count of = 1.5 x10(9)/l
6.Platelet count = 100 x 10 (9)/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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

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 small bowel adenocarcinoma
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified