Study start date: August 1, 2003Actual date on which the first participant was enrolled.
The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.
Official TitleEfficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.
Other Ways to Assign Participants Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias. None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments Parallel assignment: Participants are split into separate groups, each receiving a different treatment. Cross-over assignment: Participants switch between treatments during the study. Factorial assignment: Participants receive different combinations of treatments. Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses. Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information Single-blind: Participants do not know which treatment they are receiving, but researchers do. Double-blind: Neither participants nor researchers know which treatment is given. Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given. Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Sarcoma, Soft Tissue
Criteria
9 inclusion criteria required to participate
Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease
Target tumors outside prior radiation field(s)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count
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12 exclusion criteria prevent from participating
Subject has a diagnosis of gastrointestinal stromal tumors
Concurrent serious medical illness unrelated to tumor within the past 6 months
Known chronic infectious disease, such as AIDS or hepatitis
Positive screening pregnancy test or is breast-feeding
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.