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Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Enrollment increased: 22 → 35 participants
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 3 of 8 entries
    • Publications: details revised at 7 of 7 entries
  2. Minor Study completion date: Nov 1, 2025 to Nov 1, 2026v3
  3. Notable Phase: Not applicable to Phase 2
    • Interventions: Oligometastasis Treatment (Other) to Oligometastasis Treatment (Combination Product)
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Postoperative chemotherapy, as an important adjuvant therapy, is widely used in CRC patients aiming to reduce the risk of recurrence. Despite extensive research on the efficacy of postoperative chemotherapy in CRC, the mechanisms of postoperative recurrence, predictive factors, and strategies to enhance chemotherapy effectiveness remain unclear. For colorectal cancer patients who have achieved NED (No Evidence of Disease), the decision to either reinitiate or change the systemic chemotherapy regimen for newly developed pulmonary oligometastases remains controversial. Local treatment options for diagnosing oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic treatment should be added after local treatment in patients who have achieved NED remains uncertain , and this issue requires urgent resolution.
Trial Details
NCT Number NCT06778382
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions
(from sponsor)
Colorectal Neoplasms Malignant
Related terms Colonic Neoplasms
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov