Chemotherapy +/- vitamin supplementation in advanced Oesophagogastric cancer

ISRCTN	ISRCTN77284975
DOI	https://doi.org/10.1186/ISRCTN77284975
Secondary identifying numbers	NTR470

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 12/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr N. Groeningen, van
Scientific

VU Medical Center
Department of Medical Oncology
3 A 20
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 4441295
Email	n.gronveld@vumc.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Vitamine study
Study hypothesis	Primary objective: Does supplementation of vitamins to the combination of gemcitabine and cisplatin increase the response rate in patients with oesophagogastric cancer? Secondary objectives: 1. To assess the relationship between plasma homocysteine and plasma folic acid concentrations 2. To assess whether genetic polymorphisms in folate metabolising enzymes are related to folate homeostasis and efficacy 3. To determine the relationship between response and biomarkers for either gemcitabine and cisplatin 4. To determine whether vitamin supplementation affects pharmacokinetics of gemcitabine and cisplatin 5. To assess the time to progressive disease and overall survival 6. To assess the hematopoietic response of darbepoetin alfa
Ethics approval(s)	Received from local medical ethics committee
Condition	Oesophagogastric cancer
Intervention	Group A: patients will be treated with gemcitabine 1250 mg/m2 IV on days 1 and 8 in combination with Cisplatin 80 mg/m2 on day 1 with vitamin supplementation (Folic acid 450 ug/24 hours PO, starting at least one week prior to chemotherapy and finishing at least 3 weeks after the last treatment dose. Vitamin B12 1000 ug approximately every 9 weeks, starting 1 week before chemotherapy and finishing at least 3 weeks after the last treatment dose). Group B: patients will be treated with gemcitabine 1250 mg/m2 on days 1 and 8 in combination with Cisplatin 80 mg/m2 on day 1 without vitamin supplementation. Cycles will be administered every 21 days. A maximum of 6 cycles will be administered to every patient, although this number could be increased if the patient may benefit from it, based on investigator's criteria.
Intervention type	Other
Primary outcome measure	Response rate
Secondary outcome measures	1. Time to progression 2. Overall survival
Overall study start date	01/03/2004
Overall study end date	01/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	82
Participant inclusion criteria	1. Patients must have histologically or cytologically confirmed metastatic or locally advanced unresectable advanced oesophagogastric carcinoma (squamous or adenocarcinoma), not amenable for curative treatment 2. Patients may have received prior surgery, and chemotherapy and/or radiotherapy in neo-adjuvant or adjuvant setting as long as the chemotherapy was completed at least 6 months prior to study entry 3. Patients should have measurable disease according to RECIST criteria 4. Age of at least 18 5. Performance status (ECOG) 0, 1 or 2 6. Life expectancy of at least 12 weeks 7. Adequate bone marrow function, defined by a neutrophil count above 1.5 x 10^9/l, platelet count above 100 x 10^9/l and hemoglobin above 5.6 mmol/l 8. Adequate renal and hepatic function, defined by bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <3 x ULN (<5 x ULN is acceptable in case of liver metastasis) and creatinine <120 umol/l and/or creatinine clearance >60 ml/min (calculated by using the Cockcroft and Gault formula) 9. Patients must not already be taking vitamin supplements as defined in the protocol 10. Patients with childbearing potential must use an adequate contraceptive method 11. Patients must be able to comply with protocol procedures, able to swallow pills and have adequate geographical proximity to the study site 12. Patients must sign written informed consent
Participant exclusion criteria	1. Active infection or cardiac disease, at the investigators criteria 2. Pregnancy or breast-feeding 3. Known symptomatic metastasis in the central nervous system (CNS) 4. Treatment with any investigational agent in the month prior to inclusion 5. Other serious disease, at the investigators discretion 6. Prior diagnosis of other malignant disease, excluding adequately treated in situ carcinoma of the cervix and skin cancer other than melanoma, low grade prostate carcinoma (gleason score <6) or any other non-relapsed malignancy that was treated more than five years before diagnosis 7. Received any RBC transfusions within 14 days before first dose of Aranesp or received rHuEPO or darbepoetin alfa therapy within 4 weeks before study day 1
Recruitment start date	01/03/2004
Recruitment end date	01/03/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

VU Medical Center

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Centre (Netherlands)
Hospital/treatment centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Industry

Eli Lilly Nederland B.V. (Netherlands)

No information available

Amgen B.V. (Netherlands)

No information available

VU University Medical Center (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan