Clinical Trials in Progress

Published: Monday, Aug 20, 2012
The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Gastrointestinal Cancer

Capecitabine or observation after surgery for biliary tract cancer

This phase III study is comparing adjuvant chemotherapy with capecitabine versus expectant treatment alone following surgery for biliary tract cancer. Study participants are stratified according to surgical center, disease site (hilar/extrahepatic cholangiocarcinoma vs intrahepatic cholangiocarcinoma vs gallbladder vs intrapancreatic/common bile duct), type of resection (R0 vs R1), and ECOG performance status (0 vs 1 vs 2). Afterward, they are randomized to observation only or to treatment with oral capecitabine twice a day on days 1-14, with treatment repeated every 3 weeks for eight courses in the absence of disease progression or unacceptable toxicity. The primary outcome measure is survival at 2 years. Secondary outcome measures are survival at 5 years, relapse-free survival, toxicity, quality of life, and cost-effectiveness. The investigators aim to recruit 360 patients.

Sponsor: Southampton University Hospitals NHS Trust

ClinicalTrials.gov Identifier: NCT00363584


Oral Cancer

Radiation therapy with cisplatin or cetuximab in oropharyngeal cancer

This phase III study will compare radiotherapy plus cetuximab versus chemoradiotherapy in oropharynx cancer associated with human papillomavirus. Approximately 706 patients will be randomized at 143 study sites to one of two treatment regimens. One group of patients will undergo image-guided, intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks; they will also receive high-dose cisplatin administered intravenously (IV) over 1-2 hours on days 1 and 22. The other group will receive cetuximab IV over 2 hours starting 1 week prior to IMRT, and will then receive cetuximab IV over 1 hour once weekly for 7 weeks; they will also undergo IMRT using the same protocol as the comparator group. The primary outcome measure is 5-year overall survival. Secondary outcome measures are progression-free survival (PFS), locoregional failure, distant metastasis, acute toxicities, overall toxicity burden at the end of treatment and at 1, 3, and 6 months after the completion of treatment, and late toxicities at 1, 2, and 5 years.

Sponsor: Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT01302834


Erlotinib for prevention of oral cancer

This phase III study will test the ability of erlotinib to prevent oral cancer in the high-risk setting of oral leukoplakia with loss of heterozygosity (LOH) in two patient cohorts. One cohort includes patients with oral intraepithelial neoplasia (IEN) with LOH in 3p and/or 9p and one other specific chromosomal locus but without cancer. The other cohort includes oral IEN patients with LOH in chromosome 3p and/or 9p associated with curatively treated oral cancer. About 150 patients will be randomized to 12-month treatment with 150 mg of oral erlotinib daily or placebo. The primary outcome measure is oral cancer–free survival in patients receiving erlotinib compared with the control group. The investigators also intend to assess the size, number, and appearance of oral IEN lesions and correlate the findings with cancer risk, examine erlotinib-associated toxicity, and evaluate a panel of molecular markers for correlations with oral cancer development in patients with oral IEN. The study’s estimated primary completion date is November 2014.

Sponsor: MD Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT00402779


Head and Neck Cancer

Radiation therapy plus cisplatin with or without 5-fluorouracil for head and neck cancer


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