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A Randomized Trial Comparing Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer

Phase 3
18 Years
75 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Randomized Trial Comparing Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer

This project is in continuation of our previous study (NTUH92-S044) and is focused on the
comparison of the advantage and disadvantage of the following two treatment modalities: (1)
preoperative neoadjuvant therapy (CCRT) followed by conventional surgery; (2) the
Japanese-style of wide pelvic lymphadenectomy, for the treatment of potentially operable
locally advanced rectal cancer. It is well-known that the keypoint for the surgical
treatment of rectal cancer is to achieve a balance between ‘radical resection of the tumor’
and ‘functional preservation for the pelvic organs’. Primary adenocarcinoma of the rectum is
generally characterized by localized and comparatively slow-growing, as compared to the
fast-growing tumors of other gastrointestinal malignancies. Thus, extended systemic pelvic
lymphadenectomy has been considered the best choice for cure. However, there is major
difference of concept between the Western and Oriental colorectal surgeons regarding the
appropriate extent of lymphadenectomy for the treatment of rectal cancers lying below the
peritoneal reflection. Theoretically, there are two major pathways for the lymphatic
drainage of lower rectal cancers: one is upward to the root of inferior mesenteric artery
(IMA); the other is along the middle hemorrhoidal artery to the obturator fossa. Because the
American people tend to be very fatty and the pelvic lymphadenectomy is difficult to
perform, most rectal cancer patients receive conventional limited resection combined with
aggressive chemotherapy and pelvic irradiation. In contrast, because the Oriental people
are thinner and pelvic lymphadenectomy is easier to perform, and most important of all, the
Japanese surgeons were very meticulous in cancer surgery, the extended pelvic
lymphadenectomy has become the routine procedure for the advanced lower rectal cancer in
Japan. However, extended pelvic lymphadenectomy can inevitably cause the autonomic nerve
damage, which thereafter result in the disturbance of micturition and sexual function. To
overcome this genitourinary complication, the Japanese surgeon developed the autonomic
nerve-sparing surgery. Generally speaking, pelvic autonomic nerves consist of sympathetic
signals via the paired hypogastric nerves and paired sacral splanchnic nerves, and the
parasympathetic signals via the pelvic splanchnic nerves. The sympathetic and
parasympathetic fibers intermingled with each other to form the pelvic plexus, which is
located at the lateral side of the lateral ligament. Pelvic plexus then send the composite
autonomic signals to innervate distal rectum and genitourinary organs. Thus, the injury of
autonomic nerve can reflect the functional disorder of the anorectum and genitourinary
organs. Based on the neurophysiology, it is well known that sympathetic nerves control the
ejaculatory function and bladder neck closure. In contrast, the parasympathetic nerves
control penile erection and bladder wall contraction. Because of the difference in cultural
background of the patients and training background of the physicians between Western and
Oriental Countries, the Western people did not believe in the efficacy of wide pelvic
lymphadenectomy. In the Oriental countries, due to the shortage of standardized facilities,
treatment protocol, and manpower, the concurrent preoperative chemoradiation therapy (CCRT)
of American style is currently not widely accepted. Therefore, the advantage and
disadvantage of these two treatment modalities for advanced rectal cancers need be further
clarified. In this project, we plan to randomly assign the patients into two groups: (1)
concurrent preoperative chemoradiation therapy (CCRT) + conventional surgery group; (2) wide
pelvic lymphadenectomy group. Thereafter, we plan to evaluate: (1) the anorectal function
by anorectal manometry and colonic transit time using radioopaque markers; (2) the
micturition function using urodynamic study ; (3) the penile erection by RigiScan; and (4)
the ejaculatory function by clinical interview of the patients. Moreover, the various
clinicopathologic factors, including the depth of tumor invasion and the status of lymph
node invasion, were recorded in detail according to the guidelines recommended by the
Japanese Society of Coloproctology. Furthermore, we will evaluate the oncological results
for these patients. There are 2 characteristics for this project: (1) This is a randomized,
prospective study which has not been conducted in the literature; (2) The functional
evaluation is conducted in an objective way which is different from the reported series
based only on the subjective patient interview.

During the conduction of our precious project (NTU 92-S044), we found that the response rate
of locally advanced rectal cancer after CCRT is satisfactory. The response rate is even
more increased after the addition of oxaliplatin to the traditional regimen of 5-Fu plus
leucovorin. However, there was no significance patients between these 2 allocated groups of
patients in terms of genitourinary dysfunction. These preliminary data need be further
testified by accrual of more patients with longer time of follow-up. Therefore, it is
mandatory for us to further perform this project. We believe that this study will provide a
new balance point between the ‘radical resection’ and the ‘functional preservation’ for
advanced rectal cancer patients.

Inclusion Criteria:

- 1. Primary rectal adenocarcinoma below the peritoneal reflection 2. Tumor with
suspected lateral nodes involvement and/or T4 lesion 3. ASA class Ⅰto Ⅲ patients 4.
The life expectancy was greater than 12 weeks 5. Age of the patients between 18 and
75 years

Exclusion Criteria:

- 1. Emergency operation 2. Primary tumors with distant metastasis or peritoneal
carcinomatosis 3. Primary tumors located at other anatomical sites

Type of Study:


Study Design:

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

Outcome Measure:

oncologic results

Principal Investigator

Jin-Tung Liang, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.


Taiwan: Department of Health

Study ID:




Start Date:

January 1999

Completion Date:

June 2005

Related Keywords:

  • Colorectal Cancer
  • Rectal cancer, CCRT, Pelvic lymphadenoectomy.
  • Rectal Neoplasms
  • Colorectal Neoplasms