Clinical trial · Interventional
Efficacy of NeoThermo-Radio-chemotherapy for LA Rectal Cancer Before Laparoscopic TME: Prospective Phase II Trial
Efficacy of Neoadjuvant Thermo-Radio-chemotherapy for Locally Advanced Rectal Cancer Before Laparoscopic Total Mesorectal Excision: Prospective Phase II Trial
NCT02290574CI-TRIAL-00041402NEOTREATterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
The investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia with concurrent chemo-radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thermo-radio-chemotherapy arm
- description
- Hyperthermia with concurrent chemo-radiation therapy
- interventionNames
- Radiation: Hyperthermia with concurrent chemo-radiation therapy
Primary outcomes (3)
- measure
- Curative Resection Rate of Laparoscopic TME
- timeFrame
- expected average of 6 weeks after neoadjuvant treatement
- description
- Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament
- measure
- Pathologic Response of Thermo-radio-chemotherapy
- timeFrame
- expected average of 6 weeks after neoadjuvant treatement
- description
- The pathologic response was assessed according to the Dworak's system. The pathologic response grades were as follows: grade 0, no response; grade 1, dominant tumor mass with obvious fibrosis, vasculopathy, or both (minimal response); grade 2, dominant fibrotic changes with a few easy-to-find tumor cells or groups (moderate response); grade 3, few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance (near complete response); and grade 4, no viable tumor (complete response)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 20 years or older * pathologically confirmed rectal cancer * Eastern Cooperative Oncology Group performance status 0 to 2 * Candidate of laparoscopic TME * Optimal bone marrow function * Locally advanced rectal cancer confirmed by magnetic resonance imaging Exclusion Criteria: * Extrapelvic metastasis * Previous pelvic irradiation * Current status of pregnant or breast feeding * Confirmed other malignancy within two years except thyroid cancer
References
Publications (0)
Data not yet available
No reference posted for this study.