Clinical trial · Interventional
Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer
A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum
- 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)
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown. PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent 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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant followed by operation | Procedure | — | UNRESOLVED |
| surgical resection and adjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgical resection and adjuvant therapy
- description
- Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation
- interventionNames
- Procedure: surgical resection and adjuvant therapy
- type
- EXPERIMENTAL
- label
- Neoadjuvant followed by operation
- description
- Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.
- interventionNames
- Procedure: Neoadjuvant followed by operation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of Adenocarcinoma of the rectum 2. Age:18-80 years old 3. Received curative resection when diagnosed as rectal cancer 4. Local recurrence happened \>6 months after operation,without distant metastasis 5. Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria: * Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hepatic * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * AST ≤ 2.5 times ULN * ALT ≤ 2.5 times ULN * No hepatic disease that would preclude study treatment or follow-up * No uncontrolled coagulopathy * Renal * Creatinine clearance \> 50 mL/min * No renal disease that would preclude study treatment or follow-up 7.ECOG status: 0～1 Exclusion Criteria: 1. Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma) 2. Synchronous colon cancer 3. Hypersensitivity to fluorouracil 4. No More than 4 weeks since prior participation in any investigational drug study 5. Clear indication of involvement of the pelvic side walls by imaging With distant metastasis 6. History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception 7. Uncontrolled hypertension 8. Cardiovascular disease that would preclude study treatment or follow-up 9. Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding 10. Pregnant or nursing, Fertile patients do not use effective contraception 11. Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum 12. No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
References
Publications (0)
Data not yet available