NCT01930942

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

11.9 years

First QC Date

August 14, 2013

Last Update Submit

January 4, 2016

Conditions

Rectal Neoplasms

Keywords

rectal carcinomapreoperative concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • gene expression in different response groups

    6 months after radical surgery

Secondary Outcomes (1)

  • overall survival, disease free survival and local-regional free survival

    3 years after pre-operative chemoradiotherapy

Other Outcomes (1)

  • toxicity

    during concurrent chemoradiation

Study Arms (1)

preoperative concurrent chemoradiation

EXPERIMENTAL

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

Interventions

preoperative concurrent chemoradiationRADIATION

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.

preoperative concurrent chemoradiation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jing Jin, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Jin, MD

CONTACT

+86-13601365130jingjin1025@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Abdomen Division, Radiation Oncology Department

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 29, 2013

Study Start

January 1, 2006

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

CN(1)