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

NCT01586117 | Unknown Phase 2 DMC

• 1 other identifier: CH-GI-022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; amifostine; pre-operative chemo-radiation

Outcome Measures

Primary Outcomes (1)

• Acute radiation-induced toxicity: daily diarrhea frequency

  about 3 months from chemo-raditherapy to operation

Study Arms (1)

Amifostine

EXPERIMENTAL

intrarectal Amifostine assign to the Amifostine arm

Drug: Amifostine

Interventions

Amifostine DRUG

intrarectal Amifostine administration 1500mg QD x 5 weeks

Amifostine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Radiation Oncology Depratment, Cancer Hospital, CAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Jing Jin, M.D

  Chinese Acedemy of Medical Scinences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD

CONTACT

86-13810381399; lee_ak@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Cancer Hospital, CAMS

Study Record Dates

• First Submitted: April 22, 2012
• First Posted: April 26, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

CN (1)