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NRG ONCOLOGY NRGBN001 ClinicalTrials.gov NCT02179086. RANDOMIZED PHASE II TRIAL OF HYPOFRACTIONATED DEESCALATED PHOTON MRT OR PROTON BEAM THERAPY VERSUS CONVENTIONAL PHOTON IRRADIATION WITH CONCOMITANT

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What is a prospective phase ii?

A prospective phase II refers to a specific designation in clinical research that aims to assess the efficacy and safety of a treatment after initial phase I trials have demonstrated safety.

Who is required to file a prospective phase ii?

Researchers and sponsors who are conducting clinical trials that progress from Phase I to Phase II must file a prospective phase II.

How to fill out a prospective phase ii?

To fill out a prospective phase II, provide detailed information about the study design, objectives, methodology, subject population, and statistical analysis plan as required by regulatory guidelines.

What is the purpose of a prospective phase ii?

The purpose is to evaluate the effectiveness of the treatment in a larger group and to further assess its safety profile.

What information must be reported on a prospective phase ii?

Information that must be reported includes study objectives, design, participant eligibility criteria, treatment regimens, and outcomes to be measured.

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