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Mutation-targeted therapy with sunitinib or everolimus in patients with advanced low-grade or intermediate-grade neuroendocrine tumours of the gastrointestinal tract and pancreas with or without cytoreductive surgery: protocol for a phase II clinical trial.

Neychev V, Steinberg SM, Cottle-Delisle C, Merkel R, Nilubol N, Yao J, Meltzer P, Pacak K, Marx S, Kebebew E - BMJ Open (2015)

Bottom Line: Using the proposed criteria, 44 patients will be accrued within each treatment group during a 48-month period (a total of 88 patients for the 2 treatments), and followed for up to an additional 12 months (a total of 60 months from entry of the first patient) to achieve 80% power in order to test whether there is an improvement in PFS compared to historically expected results, with a 0.10 α level one-sided significance test.The results will be published in a peer-reviewed journal and shared with the worldwide medical community.NCT02315625.

View Article: PubMed Central - PubMed

Affiliation: Endocrine Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.

No MeSH data available.


Related in: MedlinePlus

Study flow chart. CR, complete response; PR, partial response; SD, stable disease; PD, disease progression.
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BMJOPEN2015008248F1: Study flow chart. CR, complete response; PR, partial response; SD, stable disease; PD, disease progression.

Mentions: Patients who develop disease-progression on either sunitinib or everolimus will crossover to the other drug. Treatment will continue until disease progression, unacceptable treatment-related toxicity, or consent to withdrawal. After discontinuation from the study, the patient will be contacted at three monthly intervals to obtain information about subsequent treatment(s) and survival status (figure 1).


Mutation-targeted therapy with sunitinib or everolimus in patients with advanced low-grade or intermediate-grade neuroendocrine tumours of the gastrointestinal tract and pancreas with or without cytoreductive surgery: protocol for a phase II clinical trial.

Neychev V, Steinberg SM, Cottle-Delisle C, Merkel R, Nilubol N, Yao J, Meltzer P, Pacak K, Marx S, Kebebew E - BMJ Open (2015)

Study flow chart. CR, complete response; PR, partial response; SD, stable disease; PD, disease progression.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4442235&req=5

BMJOPEN2015008248F1: Study flow chart. CR, complete response; PR, partial response; SD, stable disease; PD, disease progression.
Mentions: Patients who develop disease-progression on either sunitinib or everolimus will crossover to the other drug. Treatment will continue until disease progression, unacceptable treatment-related toxicity, or consent to withdrawal. After discontinuation from the study, the patient will be contacted at three monthly intervals to obtain information about subsequent treatment(s) and survival status (figure 1).

Bottom Line: Using the proposed criteria, 44 patients will be accrued within each treatment group during a 48-month period (a total of 88 patients for the 2 treatments), and followed for up to an additional 12 months (a total of 60 months from entry of the first patient) to achieve 80% power in order to test whether there is an improvement in PFS compared to historically expected results, with a 0.10 α level one-sided significance test.The results will be published in a peer-reviewed journal and shared with the worldwide medical community.NCT02315625.

View Article: PubMed Central - PubMed

Affiliation: Endocrine Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.

No MeSH data available.


Related in: MedlinePlus