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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Chinese Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01930942
First received: August 14, 2013
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Rectal Neoplasms
Radiation: preoperative concurrent chemoradiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Genetic Profile on Predicting Sensibility of Preoperative Chemoradiotherapy on Locally Advanced Rectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • gene expression in different response groups [ Time Frame: 6 months after radical surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival, disease free survival and local-regional free survival [ Time Frame: 3 years after pre-operative chemoradiotherapy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • toxicity [ Time Frame: during concurrent chemoradiation ] [ Designated as safety issue: Yes ]
    any G3/4 toxicities according to CTC 3.0


Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930942

Contacts
Contact: Jing Jin, MD +86-13601365130 jingjin1025@163.com

Locations
China
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Recruiting
Beijing, China, 100021
Contact: Jing Jin, MD    +8613601365130    jingjin1025@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jing Jin, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  More Information

No publications provided

Responsible Party: Jing Jin, M.D., Vice Director of Abdomen Division, Radiation Oncology Department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01930942     History of Changes
Other Study ID Numbers: D0905001040531
Study First Received: August 14, 2013
Last Updated: August 26, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chinese Academy of Medical Sciences:
rectal carcinoma
preoperative concurrent chemoradiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Carcinoma
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014