Clinical trial · Interventional
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
NCT01586117CI-TRIAL-00011771unknownPhase 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 purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.
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 |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Amifostine
- description
- intrarectal Amifostine assign to the Amifostine arm
- interventionNames
- Drug: Amifostine
Primary outcomes (1)
- measure
- Acute radiation-induced toxicity: daily diarrhea frequency
- timeFrame
- about 3 months from chemo-raditherapy to operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0). * tumor distance from anus less than 12 cm. * KPS score not less than 70 * can be tolerated chemotherapy and radiotherapy. * pelvic who had no history of radiation therapy. * Non-allergic history of fluorouracil or platinum-based chemotherapy drugs. * blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90). * a 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.