Criteria for discontinuing or modifying allocated interventions {11b}
toxicity, psychiatric
Patients meeting either of the following criteria will discontinue the study treatment:Permanent discontinuation of paclitaxel by treating physician (unacceptable toxicity or progression of underlying cancer)Completion of planned duration or 6 cycles of paclitaxelIf the investigator determines that continuation of the study treatment is not in the patient’s best interestOccurrence of an exclusion criterion affecting patient safety during the conduct of the trial, e.g., pregnancy or psychiatric illnessInitiation of concomitant treatment that is not permittedFailure to comply with the protocol. If a patient consistently fails to attend scheduled assessments in the study, the investigator will determine the reasons and document the circumstances as thoroughly and accurately as possible in the medical recordsThe patient declines subsequent treatment or withdraws consent