Box 122 Circumstances in which international planning is needed

♦ To achieve adequately large and sufficiently rapid intakes into trials in rare cancers

♦ To study uncommon treatment situations in common cancers

♦ To achieve rapid intakes into large trials in centres' programmes of trials, avoiding undesirable duplication, and collaboration in a single trial or a joint analysis of trials to be run in parallel (see Box 12.2).

International collaboration is essential for achieving rapid, adequately sized intakes into randomized trials in uncommon cancers, and has been highly productive in trials in advanced bladder cancer, testicular cancer, gliomas, ovarian cancer, osteosarcoma and lymphoma. International collaboration is also helpful in studying uncommon therapeutic situations related to common cancers and in achieving rapid intakes into large trials. For example, colorectal cancer is common, but only occasionally is it thought that resection of an isolated liver or lung metastasis should be undertaken. When such resection is considered desirable, it is not known whether giving post-operative chemotherapy might benefit the patient. The European Organization for Research and Treatment of Cancer, the National Cancer Institute of Canada, and the Gruppo Interdis-ciplinare Valutazione Interventi in Oncologia therefore collaborated in a comparison of chemotherapy versus no chemotherapy following potentially curative resection of liver or lung metastases from colorectal cancer (EORTC protocol 40923); 478 patients were randomized during forty-four months.

An example of a large pragmatic trial involving international collaboration is the ICON3 trial. This compared paclitaxel plus carboplatin versus non-paclitaxel control chemotherapy as first-line treatment for advanced ovarian cancer; 2074 patients were randomized from 132 hospitals in eight countries during forty-three months [1].

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