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Related Concept Videos

Clinical Trials01:16

Clinical Trials

11.0K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
11.0K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.2K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Treatment Resistant Cancers02:56

Treatment Resistant Cancers

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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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Related Experiment Video

Updated: Mar 5, 2026

Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma
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Establishment of a Primary Culture of Patient-derived Soft Tissue Sarcoma

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Phase III Soft Tissue Sarcoma Trials: Success or Failure?

Alexander T J Lee1,2, Seth M Pollack3,4, Paul Huang2

  • 1Sarcoma Unit, The Royal Marsden NHS Foundation Trust, London, UK.

Current Treatment Options in Oncology
|March 24, 2017
PubMed
Summary

New systemic therapies for advanced soft tissue sarcoma (STS) show promise, but phase III trials highlight the need for better patient subgroup identification. Further research is needed to validate surrogate endpoints like progression-free survival (PFS).

Keywords:
Clinical trial designSoft tissue sarcomaSystemic therapyTrial endpoints

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Area of Science:

  • Oncology
  • Clinical Trials
  • Pharmacology

Background:

  • Recent phase III trials have led to new systemic therapies for advanced soft tissue sarcoma (STS).
  • Phase II data guided trial design, identifying sensitive STS diagnoses and demonstrating subtype-specific benefits.
  • However, many recent phase III trials have failed to replicate earlier efficacy signals in heterogeneous patient cohorts.

Purpose of the Study:

  • To emphasize the need for identifying specific histological and molecular subgroups in STS for targeted treatment.
  • To discuss the increasing importance of surrogate efficacy endpoints in STS drug trials due to prolonged overall survival.
  • To advocate for progression-free survival (PFS) as a primary endpoint in first-line STS studies and explore advanced response assessment techniques.

Main Methods:

  • Review of recently reported phase III randomized control trials (RCTs) in advanced soft tissue sarcoma.
  • Analysis of trial designs informed by phase II data and their outcomes.
  • Discussion of efficacy signals, patient cohort heterogeneity, and endpoint selection in STS drug development.

Main Results:

  • Two new systemic therapies for advanced STS have been registered based on phase III RCTs.
  • A pattern of lost efficacy signals in large, heterogeneous cohorts has been observed in several recent phase III trials.
  • Overall survival (OS) in advanced STS has improved, increasing the importance of surrogate endpoints.

Conclusions:

  • Greater efforts are required to identify patient subgroups with differential treatment responses to avoid costly phase III trial failures.
  • Progression-free survival (PFS) may be a more appropriate primary endpoint for first-line STS studies, pending further validation.
  • Development of sophisticated radiological response assessment and inclusion of quality-of-life endpoints are crucial for future STS trials.