A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01586117

Enrollment

Registered

2012-04-26

Start date

2012-02-29

Completion date

2014-12-31

Last updated

2013-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer, amifostine, pre-operative chemo-radiation

Brief summary

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.

Detailed description

To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Interventions

DRUGAmifostine

intrarectal Amifostine administration 1500mg QD x 5 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Acute radiation-induced toxicity: daily diarrhea frequency	about 3 months from chemo-raditherapy to operation

Countries

China

Contacts

Primary ContactNing Li, MD

lee_ak@163.com86-13810381399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026