Clinical trial · Interventional
A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
NCT02941562CI-TRIAL-00024409unknownPhase 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)
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
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, Radiotherapy | Malignant Rectal Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemotherapy of neo-adjuvant therapy | Drug | — | UNRESOLVED |
| FOLFOX4 chemotherapy,post-operative | Drug | — | UNRESOLVED |
| FOLFOX4 chemotherapy,preoperative | Drug | — | UNRESOLVED |
| Radical rectal cancer resection | Procedure | — | UNRESOLVED |
| Radiotherapy of neo-adjuvant therapy | Radiation | — | UNRESOLVED |
| Short-course radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative chemotherapy with short-course radiotherapy
- description
- Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
- interventionNames
- Radiation: Short-course radiotherapy
- Drug: FOLFOX4 chemotherapy,preoperative
- Procedure: Radical rectal cancer resection
- Drug: FOLFOX4 chemotherapy,post-operative
- type
- ACTIVE_COMPARATOR
- label
- Preoperative neo-adjuvant therapy
- description
- Preoperative treatment:neo-adjuvant therapy
- interventionNames
- Radiation: Radiotherapy of neo-adjuvant therapy
- Drug: Concurrent chemotherapy of neo-adjuvant therapy
- Procedure: Radical rectal cancer resection
- Drug: FOLFOX4 chemotherapy,post-operative
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Consent to this study * 2\. Histological or cytological confirmed diagnostic of rectal carcinoma * 3\. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI) * 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction * 5.With no presence of other organ metastasis or extra-regional lymph node involvement * 6.With no history of chemotherapy * 7.ECOG score is 0 or 1 * 8.Adequate ability of bone marrow, liver and kidney function * 9.No pregnancy Exclusion Criteria: 1. Unable to intake oral medicine 2. Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe 3. HIV infection or Active chronic HBV or HCV 4. Severe clinical infection at active stage 5. Epileptic seizure need treatment 6. History of organ transplantation 7. Renal failure or intaking renal dialysis 8. Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics 9. Severe unhealed wound or skin ulcer or bone fraction 10. Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years 12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.