NCT04751409 Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities
| NCT ID | NCT04751409 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 227 participants |
| Start Date | 2020-12-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 227 participants in total. It began in 2020-12-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.
Eligibility Criteria
IInclusion Criteria: * ≥18 years old * Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment * Willingness to complete surveys x 2 years Exclusion Criteria: * Documented metastatic disease at the time of enrollment * Non-English-speaking patients Pregnant women will be included in this clinical trial.
Contact & Investigator
Christina L Roland, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04751409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04751409 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04751409 currently recruiting?
Yes, NCT04751409 is actively recruiting participants. Contact the research team at clroland@mdanderson.org for enrollment information.
Where is the NCT04751409 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04751409 clinical trial?
NCT04751409 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Christina L Roland, MD at M.D. Anderson Cancer Center. The trial plans to enroll 227 participants.