Clinical trial · Interventional
Preoperative Chemoradiotheray for Rectal Cancer
Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study
NCT00819559CI-TRIAL-00001881unknownN/AClinicalTrials.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)
Hypothesis * Pre operative radio-chemotherapy might be not mandatory to improve local recurrent rate and survival rate in the mid-lower rectal cancer patients with T3N0 clinical stage, if surgical principals were kept. * Laparoscopic resection is not inferior to Open surgery in the treatment of 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 Neoplasm | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Open PCRT group
- description
- Patients who underwent preoperative chemoradiotherapy and open resection
- interventionNames
- Radiation: PCRT
- type
- EXPERIMENTAL
- label
- Open no PCRT group
- description
- Patients who did not undergo preoperative chemoradiotherapy and open resection
- interventionNames
- Radiation: PCRT
- type
- ACTIVE_COMPARATOR
- label
- LAP PCRT group
- description
- Patients who underwent preoperative chemoradiotherapy and laparoscopic resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically demonstrated and cytologically evident rectal cancer (Glandular carcinoma: located on 4-12cm from anus), the case without remote metastasis * Age: 18-70 years old * The patients who did not undergo radiation therapy, surgery or antitumor agent therapy with the same disease medical history * The patients with clinical stage of T3N0 identified by ultrasound or MRI * Appropriate bone marrow, liver and renal function as follow; granulocyte ≥ 1500, platelet ≥ 80,000, bilirubin \< 1.5 mg/dl , Serum Creatinine \< 1.5 mg/dl, BUN \< 30, * The patients who understood the rights to withdraw the agreement at any time and signed on the informed consent form with or without their legal representatives. Exclusion Criteria: * Remote metastatic disease * When the patient is concerned about the local recurrence if the preoperative chemo-radiation therapy is not undergone, or when the patient expects that the possibility of conservation of sphincter is improved owing to the preoperative chemo-radiotherapy. * Pregnancy * Radiotherapy, the past history of operation or chemotherapy * Familial multiple polyp * Uncontrolled psychiatric disorder, chronic alcohol disease or drug addiction and CNS(Central Nervous System) disorder * Other malignant disorder * After the radiotherapy or the case which remote metastasis is detected during the surgery * The case which has splanchnemphraxis or the risk of progression to occlusion during the examination period * Those patients who do not agree to participate in this study * The patients who seemed to be likely to stop in the middle of clinical study. * The patients who cannot undergo the regular follow-up owing to the following reasons. For instance, the patients who have psychologic, social, family or geographic reason or the patients who have difficulties in observing proper follow-up or clinical examination plan. Also, the patient who the doctor considers them as improper subjects of this study
References
Publications (0)
Data not yet available
No reference posted for this study.