Clinical trial · Interventional
Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy
Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
NCT03071198CI-TRIAL-00026309unknownN/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)
Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower 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 |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant CT | Drug | — | UNRESOLVED |
| Concurrent chemo-radiotherapy | Radiation | — | UNRESOLVED |
| neoadjuvant CT | Drug | — | UNRESOLVED |
| TME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Preoperative neoadjuvant CT
- description
- Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
- interventionNames
- Procedure: TME
- Drug: neoadjuvant CT
- Drug: adjuvant CT
- type
- EXPERIMENTAL
- label
- Preoperative neoadjuvant CT-RCT
- description
- Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
- interventionNames
- Procedure: TME
- Radiation: Concurrent chemo-radiotherapy
- Drug: neoadjuvant CT
- Drug: adjuvant CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
* Inclusion criteria
* Pathologically confirmed to be rectal adenocarcinoma.
* Distance \< 10cm from the end of the tumor to the anal verge found on colonoscopy
* Tumor in stage T3-4N0-2 (pelvic MRI evaluation)
* Patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes)
* Patients with Karnofsky score greater ≥ 70
* WBC \> 3.5 x 109/ml , PLT \> 10 x 109/ml , TBIL\<22.2 umol/l , BUN \<7.14mmol/l , Cr\<132umol/l or Ccr \> 50ml/min (Evaluated using the Cockcroft-Gault formula: Creatinine clearance (male) = {(140 - age) x LBM (kg)} / {plasma creatinine (mg/dl) x 72} ; Creatinine clearance (female) = 0.85 x {(140 - age) x LBM(kg)}/ { plasma creatinine (mg/dl) x 72})
* Patients must sign the informed consent form
* Female subjects must be contraceptive during the trial
* Patients who did not receive any form of chemotherapy and radiotherapy
* No other important related diseases (such as other tumors, severe heart disease and central nervous system diseases, etc.)
* Age must be equal or more than 20 and must be equal or less than 70
* Exclusion criteria
* Previously received radiation therapy, chemotherapy or anti-tumor biological therapy
* Previously received immuno-suppressive therapy
* Participation in interventional clinical trial over the past time
* Suffering from malignant colonic neoplasms simultaneously
* With peripheral neuropathy(above WHO I level)
* Affected cognitive abilities because of neurological or psychiatric abnormalities Including central nervous system metastasis
* Medical history of severe allergies or allergic constitution
* Severe pulmonary or heart disease history
* Female patients who are in pregnancy or lactation and refuse contraception
* Previously with other malignant tumors
* Exit criteria
* Occurrence of bleeding, obstruction, perforation and other complications
* Occurrence of distant metastasis during the period of neoadjuvant therapy
* Adverse reactions, not be tolerated and do not want to continue to receive treatment
* Patients voluntarily quit
* Capecitabine-related Grade 4 Hand-Foot SyndromeReferences
Publications (0)
Data not yet available
No reference posted for this study.