Clinical trial · Interventional
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
NCT04664504CI-TRIAL-00052161unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| Concurrent Chemoradiotherapy Radiotherapy | Combination Product | — | UNRESOLVED |
| Consolidation chemotherapy | Drug | — | UNRESOLVED |
| Local dose increase of Short-course Radiotherapy | Radiation | — | UNRESOLVED |
| Short-course Radiotherapy | Radiation | — | UNRESOLVED |
| TME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group CRT
- description
- concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
- interventionNames
- Combination Product: Concurrent Chemoradiotherapy Radiotherapy
- Drug: Adjuvant chemotherapy
- Procedure: TME
- type
- EXPERIMENTAL
- label
- Group SCRT
- description
- Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
- interventionNames
- Radiation: Short-course Radiotherapy
- Drug: Consolidation chemotherapy
- Procedure: TME
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Rectal adenocarcinoma confirmed by histopathology 2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+) 3. The age is 18-75 years old, no gender limit 3\) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1 Exclusion Criteria: 1. History of other malignant tumors; 2. They were allergic to 5-FU, platinum, etc; 3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred; 4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal; 5. History of gastrointestinal fistula, perforation or severe ulcer; 6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.