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Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment. A phase III trial

Laufzeit: 01.01.2015 - 31.12.2022

Kurzfassung


Randomized, parallel group, multicenter phase III trial.
First-line treatment for metastatic colorectal cancer (mCRC) should be administered according to the individual situation, patient’s needs, therapeutic preconditions (e.g. neurotoxicity following adjuvant treatment with oxaliplatin), biomarkers and aggressiveness of the disease.
Continuation of the initial combination chemotherapy beyond 3-6 months is not recommended for most patients, in particular if using drugs causing cumulative...
Randomized, parallel group, multicenter phase III trial.
First-line treatment for metastatic colorectal cancer (mCRC) should be administered according to the individual situation, patient’s needs, therapeutic preconditions (e.g. neurotoxicity following adjuvant treatment with oxaliplatin), biomarkers and aggressiveness of the disease.
Continuation of the initial combination chemotherapy beyond 3-6 months is not recommended for most patients, in particular if using drugs causing cumulative toxicity such as oxaliplatin. Depending
on the physician’s and patient’s choice, as well as on the local pattern of practice and aim of treatment, the original induction therapy might then either be completely discontinued or be continued without any change until progression of disease or be continued using fewer and less toxic agents (e.g. single agent
fluoropyrimidine and/or bevacizumab).
Within the IMPALA trial, patients who de-escalate or completely halt all induction treatments should be re-challenged with the same initial regimen as soon as tumor progression becomes evident. In contrast, patients who continued the original induction treatment will start an appropriate second-line treatment
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