Clinical trial · Interventional
Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma
NCT01930942CI-TRIAL-00020418unknownPhase 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 aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.
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 Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| preoperative concurrent chemoradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- preoperative concurrent chemoradiation
- description
- Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
- interventionNames
- Radiation: preoperative concurrent chemoradiation
Primary outcomes (1)
- measure
- gene expression in different response groups
- timeFrame
- 6 months after radical surgery
Secondary outcomes (1)
- measure
- overall survival, disease free survival and local-regional free survival
- timeFrame
- 3 years after pre-operative chemoradiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed rectal adenocarcinoma, preoperative stage II / III (T3-4N0 or T1-4N + M0). * Distance from the lower bound of tumor to the anal verge is less than 12 cm. * KPS score not less than 70 * Can be tolerated chemotherapy and radiotherapy. * No history of radiation therapy to the pelvis. * Non-allergic history of fluorouracil or platinum-based chemotherapy drugs. * Full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. - Exclusion Criteria: * Other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). * Pregnant or lactating patients. * Fertility but did not use contraceptive measures. * Existing active infection. * Merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. * Concurrent treatment with other anticancer drugs. * Can not complete treatment or follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.