Current investigations

Prospective study on chemotherapy during pregnancy: pharmacokinetics and paediatric outcome

Cancer complicates approximately 1 in 1000-1500 pregnancies. Since maternal age of pregnant women increases steadily during the last decennium, also the detection of cancer among pregnant women is expected to increase. Retrospective data on pregnancy outcome after oncological treatment during pregnancy are relatively reassuring. Although, in order to inform patients adequately about the risks of the administration of chemotherapy or radiotherapy during pregnancy, we need more solid data on the pharmacokinetics of chemotherapy during pregnancy and on the short and long term outcome of the mother and her child.

We have therefore initiated a prospective study with the intention to determine the pharmacokinetics of cytotoxic drugs during pregnancy and to evaluate the short and long term outcome of the children. This trial is currently open for inclusion.

End-points

Primary end-points

  • Short term outcome of children after in utero exposure to chemo/radiotherapy (till the age of 18 months)
  • Determination of pharmacokinetic distribution of cytotoxic drugs when administered during pregnancy

Secondary end-points

  • Long term outcome of children after in utero exposure to chemo/radiotherapy
  • Set up of a database for the registration of oncological problems during pregnancy (diagnosis, treatment, outcome)

Study population

Inclusion Criteria

Patients must meet all of the following inclusion criteria:

  • Histological proven cancer
  • Patients must be fit to receive chemotherapy or radiotherapy during pregnancy
  • Targeted treatment administered during pregnancy is allowed
  • Patients must have adequate bone marrow, renal, hepatic and pulmonary function
  • WHO performance status 0 or 1
  • > 18 years of age
  • Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
  • Women receiving any cytotoxic drug during pregnancy are allowed for the assessment of the maternal and fetal outcome

  • Patients are allowed to opt for the pharmacokinetic part or clinical follow-up part of the study only and do not need to participate in both; however, preferentially both study parts should be performed

Exclusion criteria

  • Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent

Documents that can be obtained*

* Please use the form name as the subject of the mail, so we can easily send the correct form to you.

Contact

Frédéric Amant MD PhD
Verloskunde-Gynaecologie
UZ Gasthuisberg
Herestraat 49
3000 Leuven
Tel: +32-16-344634
Fax: +32-16-344629
frederic.amant@uz.kuleuven.ac.be

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