Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

Rectal Neoplasms Clinical Trial

Official title:

Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930942
• Other study ID #: D0905001040531
• Status: Recruiting
• Phase: Phase 2
• First received: August 14, 2013
• Last updated: January 4, 2016
• Start date: January 2006
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, MD
• Phone: +86-13601365130
• Email: jingjin1025[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to find some genetic factors in predicting the sensibility of preoperative chemoradiotherapy for locally advanced rectal carcinoma.

Description:

For locally advanced rectal carcinoma,preoperative chemoradiotherapy(CRT) achieved similar overall survival and better local control compared with postoperative therapy,so it was considered to be one of the standard therapy of these patients.But,not every one will be cured,the possible reason is the difference gene expression and mutation status among patients.So,we performed this trial to study the relationship between genetic factors and response of preoperative CRT for locally advanced rectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Radiation:
• preoperative concurrent chemoradiation
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.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	toxicity	any G3/4 toxicities according to CTC 3.0	during concurrent chemoradiation	Yes
Primary	gene expression in different response groups		6 months after radical surgery	No
Secondary	overall survival, disease free survival and local-regional free survival		3 years after pre-operative chemoradiotherapy	No