Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204).

Background: The addition of bevacizumab to chemotherapy improved outcomes for patients with metastatic colon cancer. E5204 was designed to test whether the addition of bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery, could improve overall survival (OS) in patients with stage II/III adenocarcinoma of the rectum.

Subjects, Materials, And Methods: Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled.

A Comparison of white and African American outcomes from a three-arm, randomized, phase III multicenter trial of advanced or metastatic non-small cell lung cancer.

Purpose: To investigate the effect of race on the efficacy and safety of standard chemotherapy doublet regimens in African American patients, we conducted a subgroup analysis of a phase III randomized trial.

Patients And Methods: Chemonaïve patients with a performance status of 0 or 1 and stage IIIB or IV non-small cell lung cancer were randomized to arm A: gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1; arm B: the same schedule of gemcitabine plus paclitaxel 200 mg/m2 on day 1; or arm C: paclitaxel 225 mg/m2 on day 1 plus carboplatin area under the curve 6.

A retrospective analysis of outcomes by age in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel vs. paclitaxel plus carboplatin for advanced non-small cell lung cancer.

Purpose: Sufficient data are currently unavailable to assist in defining suitable regimens for patients ≥ 70 years with advanced non-small cell lung cancer (NSCLC).

Methods: Chemonaïve patients with a performance status (PS) of 0 or 1 and stage IIIB or IV NSCLC were randomized to gemcitabine 1000mg/m(2) on days 1 and 8 plus carboplatin area under the curve (AUC) 5.5 on day 1; the same schedule of gemcitabine plus paclitaxel 200mg/m(2) on day 1; or paclitaxel 225mg/m(2) on day 1 plus carboplatin AUC 6.

American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical trial sites.

Purpose: To describe both minimum requirements for a site conducting quality clinical trials and attributes of an exemplary site.

Methods: Minimum requirements and exemplary attributes were selected based on literature review, prevailing regulatory requirements, and consensus among a group of community and academic clinical researchers.

Results: To provide guidance to oncologists who wish to conduct patient-oriented research, recommendations are made to assist in the development and implementation of high-quality research programs with the priority of protecting the welfare and rights of trial participants.

Recommended guidelines for the treatment of cancer treatment-induced diarrhea.

Purpose: To update and expand on previously published clinical practice guidelines for the treatment of cancer treatment-induced diarrhea.

Methods: An expert multidisciplinary panel was convened to review the recent literature and discuss recommendations for updating the practice guidelines previously published by this group in the Journal of Clinical Oncology in 1998. MEDLINE searches were performed and the relevant literature published since 1998 was reviewed by all panel members.

Informed consent: a crucial step in cancer patient education.

Informed consent is an issue of major importance for cancer patients and for the practitioners who treat them. Recently, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research emphasized the educational goals of the consent process. Nevertheless, past research confirms that these goals are difficult to attain.