Clinical trial · Interventional
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During During Neoadjuvant Chemoradiation With Capecitabine and Irinotecan
- 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)
This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dosimetric limitation of pelvic bone and peritoneal space during radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental arm
- description
- peritoneal space V15\<850cc，pelvic bone V10\<80% and normal dosimetric limitation
- interventionNames
- Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy
- type
- NO_INTERVENTION
- label
- control arm
- description
- normal dosimetric limitation
Primary outcomes (1)
- measure
- Number of Participants Experiencing Adverse Events
- timeFrame
- up to 3 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with rectal adenocarcinoma 2. Clinical staged T3/4 or any node-positive disease 3. Age of 18-75 years 4. Karnofsky Performance Status \> 80 5. Adequate bone marrow reserve, renal and hepatic functions 6. Without previous antitumoural chemotherapy 7. No evidence of metastatic disease 8. Written informed consent before randomization 9. UGT1A1's genotype of 6/6 or 6/7 Exclusion Criteria: 1. Clinical staged I or IV 2. Age of \<18 or \>75 years 3. Karnofsky Performance Status \< 80 4. Previous pelvis radiotherapy 5. Previous antitumoural chemotherapy 6. Clinically significant internal disease 7. Refuse to write informed consent before randomization 8. UGT1A1's genotype of 7/7
References
Publications (0)
Data not yet available