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Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study

18 Years
70 Years
Not Enrolling
Rectal Neoplasm

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Trial Information

Role of Preoperative Chemoradiotherapy in Clinically T3No Mid and Low Rectal Cancer : Multi-Institute Clinical Study

It is known that 20-60% of the rectal cancer patients treated with radical resection have
the local recurrence. Therefore, chemo-radiotherapy before or after operation have been the
standard treatment protocol in the rectal cancer patients to reduce the local recurrence,
preserve more surrounding pelvic viscera, improve the prognosis and eventually quality of
life. The preoperative chemo-radiotherapy was introduced by the German Rectal Cancer study,
which compared pre- and postoperative chemo and radiotherapy. In this study, the authors
reported that preoperative chemo-radiotherapy reduced local recurrent rate and 3 or 4 degree
toxicity and improved the compliance for treatment. Since the introduction of chemo and
radiotherapy in the treatment of rectal cancer, there have been numerous controversies on
the guidelines or protocols of chemo-radiotherapy. In 1990, National Institute of Health
(NIH) recommended postoperative chemo- radiotherapy to all the pT3 or pN1 rectal cancer
patients at the consensus conference. In some studies, they reported that good clinical
outcome and low local recurrence rate were obtained by only surgical treatment in the pT3N0
rectal cancer patients with favourable pathological characteristics. They also insisted that
the effectiveness of postoperative chemo- radiotherapy was not evident. Gunderson, et al.
retrospectively evaluated the five-year survival rate of the pT3N0 patients. They reported
that the patients with surgery and chemotherapy showed the similar survival rate with the
patients who underwent surgery and postoperative chemo-radiotherapy. National Cancer Data
Base showed the similar report. However, there are some problems to apply theses results to
the decision of preoperative therapeutic options. Moreover, some papers showed the low local
recurrent rate (less than 5%) in the stage II without the supplement therapy, when the TME
was precisely performed. All these results present the controversies on the
radio-chemotherapy on all the T3N0 patients in terms of the clinical outcomes and the
prognosis. In Korea, numerous clinical trials have been performed on the rectal cancer
patients, however there has been no clinical study for preoperative chemo- radiotherapy in
the T3N0 rectal cancer patients. In this reason, the protocols are different among
institutions without unified standard treatment protocol. In this study, the authors compare
the accuracy of diagnosis, the functional differences according to the preoperative chemo-
radiotherapy, the local recurrent rate and survival rate between the two groups of T3N0
patients; one group with preoperative chemo-radiotherapy vs. the other without. In addition,
the authors evaluate the advantage of the laparoscopic surgery, such as an extensive vision,
so that laparoscopy can help rectal surgery as well as the surgical outcome.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

5 year

Safety Issue:


Principal Investigator

Gyu-Seog Choi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

School of Medicine, Kyungpook National University


Korea: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

December 2016

Related Keywords:

  • Rectal Neoplasm
  • Rectal neoplasm
  • Clinical stage
  • T3N0
  • Preoperative chemoradiotherapy
  • Laparoscopic
  • Open resection
  • Neoplasms
  • Rectal Neoplasms