NCT00819559

Brief Summary

Hypothesis

  • Pre operative radio-chemotherapy might be not mandatory to improve local recurrent rate and survival rate in the mid-lower rectal cancer patients with T3N0 clinical stage, if surgical principals were kept.
  • Laparoscopic resection is not inferior to Open surgery in the treatment of rectal cancer.

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
1,160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

1.9 years

First QC Date

January 7, 2009

Last Update Submit

January 8, 2009

Conditions

Rectal Neoplasm

Keywords

Rectal neoplasmClinical stageT3N0Preoperative chemoradiotherapyLaparoscopicOpen resection

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    5 year

Secondary Outcomes (1)

  • Overall survival Local recurrence Early or late complication associated with preoperative radiotherapy Quality of life Accuracy of clinical staging Difference of surgical outcome between laparoscopic and open surgery

    Up to 2 years

Study Arms (4)

Open PCRT group

ACTIVE COMPARATOR

Patients who underwent preoperative chemoradiotherapy and open resection

Radiation: PCRT

Open no PCRT group

EXPERIMENTAL

Patients who did not undergo preoperative chemoradiotherapy and open resection

Radiation: PCRT

LAP PCRT group

ACTIVE COMPARATOR

Patients who underwent preoperative chemoradiotherapy and laparoscopic resection

Radiation: PCRT

LAP no PCRT group

EXPERIMENTAL

Patients who did not undergo preoperative chemoradiotherapy and laparoscopic resection

Radiation: PCRT

Interventions

PCRTRADIATION

Preoperative chemoradiotherapy

Also known as: preoperative chemoradiotherapy
LAP PCRT groupLAP no PCRT groupOpen PCRT groupOpen no PCRT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically demonstrated and cytologically evident rectal cancer (Glandular carcinoma: located on 4-12cm from anus), the case without remote metastasis
  • Age: 18-70 years old
  • The patients who did not undergo radiation therapy, surgery or antitumor agent therapy with the same disease medical history
  • The patients with clinical stage of T3N0 identified by ultrasound or MRI
  • Appropriate bone marrow, liver and renal function as follow; granulocyte ≥ 1500, platelet ≥ 80,000, bilirubin \< 1.5 mg/dl , Serum Creatinine \< 1.5 mg/dl, BUN \< 30,
  • The patients who understood the rights to withdraw the agreement at any time and signed on the informed consent form with or without their legal representatives.

You may not qualify if:

  • Remote metastatic disease
  • When the patient is concerned about the local recurrence if the preoperative chemo-radiation therapy is not undergone, or when the patient expects that the possibility of conservation of sphincter is improved owing to the preoperative chemo-radiotherapy.
  • Pregnancy
  • Radiotherapy, the past history of operation or chemotherapy
  • Familial multiple polyp
  • Uncontrolled psychiatric disorder, chronic alcohol disease or drug addiction and CNS(Central Nervous System) disorder
  • Other malignant disorder
  • After the radiotherapy or the case which remote metastasis is detected during the surgery
  • The case which has splanchnemphraxis or the risk of progression to occlusion during the examination period
  • Those patients who do not agree to participate in this study
  • The patients who seemed to be likely to stop in the middle of clinical study.
  • The patients who cannot undergo the regular follow-up owing to the following reasons. For instance, the patients who have psychologic, social, family or geographic reason or the patients who have difficulties in observing proper follow-up or clinical examination plan. Also, the patient who the doctor considers them as improper subjects of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korean Rectal Cancer Study Group

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gyu-Seog Choi, M.D.

    School of Medicine, Kyungpook National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

InJa Park, M.D.

CONTACT

82-2-519-8975ijpark7@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 9, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2011

Study Completion

December 1, 2016

Last Updated

January 12, 2009

Record last verified: 2009-01

Locations

KR(1)