Phase II Study of Conservative Treatment of Adenocarcinoma of the Distal Rectum: Local Resection Followed by Adjuvant Radiotherapy with 5-FU Radiosensitization

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCICLB-8984
E-C8984, RTOG-9109, SWOG-9306, CALGB-8984


I.  Determine whether survival among patients with T1-2 adenocarcinoma of the 
distal rectum treated conservatively with sphincter-sparing local resection 
followed by adjuvant radiotherapy plus fluorouracil is comparable to that of 
historical controls treated with radical, abdominoperineal resection.

II.  Determine whether survival among patients with T3 adenocarcinoma of the 
distal rectum treated conservatively is comparable to that of historical 
controls treated radically.

III.  Assess, as a function of stage, the locoregional recurrence rate of 
these patients treated with conservative surgery.

IV.  Determine the failure-free survival of these patients as a function of 

V.  Assess the toxicity of combining limited, sphincter-sparing surgery with 
postexcisional chemoradiotherapy in the treatment of less favorable low-lying 
adenocarcinoma of the rectum.

VI.  Determine the effects of sphincter-sparing surgery on bowel and bladder 
function and on sexual capacity.

VII.  Correlate clinical selection criteria (tumor size, circumferential 
involvement) with the ability to perform sphincter-sparing surgery.

VIII.  Refine quantitatively the following prognostically important factors 
for predicting survival and/or recurrence:  tumor size, extent of 
circumferential involvement, depth of invasion, exophytic vs. endophytic 
growth, tumor grade, endothelial-lined vs. vascular space invasion, mucin 
production, patient age, gender, and pre- and postoperative CEA levels. 

IX.  Determine the survival and failure free survival in these patients 
following abdominoperineal resection after a relapse from the original 
conservative sphincter sparing surgical procedure.

Entry Criteria

Disease Characteristics:

Biopsy-proven adenocarcinoma of the distal rectum
 Biopsy not required for patients with villous adenomas

Proximal extent of tumor resection should not extend higher
than 10 cm above the dentate line and must be below the
pelvic peritoneal reflection

Clinical Stage T1-3 disease required, as follows:
 No greater than 4 cm in diameter
 No more than 40% of the rectal circumference involved
 Clinical Stage T3 allowed only at ECOG and RTOG institutions

No clinical or imaging evidence of regional lymph node
 Biopsy of palpable perirectal nodes or nodes larger than 1 cm
  on CT scan required prior to or at the time of surgery

 If no preoperative CT scan was performed, a postoperative
  scan with biopsy of enlarged nodes is required prior to
   postoperative registration

Subtotal removal of tumors, removal of tumor in pieces, or
microscopically positive margins following resection at an
outside institution allowed provided complete transmural
re-excision is performed at a member or affiliate institution

The following disease states specifically excluded:
 Fixation to perirectal tissue
 Multifocal involvement

Clinical evaluation by all treating physicians required prior
to postoperative registration for T2 and T3 tumors (not
required for T1 tumors)

Prior/Concurrent Therapy:

Biologic therapy:
 No prior therapy

 No prior therapy

Endocrine therapy:
 No prior therapy

 No prior therapy

 See Disease Characteristics
 No prior definitive surgery
 Incomplete prior resection allowed 
 Diagnostic biopsy allowed

Patient Characteristics:

 18 and over

Performance status:
 CALGB 0-2

Life expectancy:
 At least 2 years

 WBC at least 4,000/mm3
 Platelet count at least 130,000/mm3
 Hemoglobin greater than 10 g/dL

 Bilirubin less than 1.5 times normal
 SGOT/SGPT less than 1.5 times normal

 Creatinine less than 1.8 mg/dL
 BUN less than 1.5 times normal

 No serious medical or psychiatric condition that would
  prevent informed consent
 No second malignancy within the past 5 years except:
  Inactive nonmelanomatous skin cancer
  In situ cervical cancer
 Not pregnant or nursing

Expected Enrollment

300 patients will be accrued to obtain 195 eligible patients (90 patients with 
T1-2 rectal cancer and 105 patients with T3 rectal cancer) and results 
compared to 300 historical controls for each group who underwent 
abdominoperineal resection.


All patients undergo local excision of tumor. T1 patients are followed without 
further treatment. T2 and (T3 for ECOG or RTOG institutions) patients receive 
adjuvant radiotherapy plus fluorouracil. 

Patients are followed for survival.

Published Results

Steele GD Jr, Herndon JE, Bleday R, et al.: Sphincter-sparing treatment for distal rectal adenocarcinoma. Ann Surg Oncol 6 (5): 433-41, 1999 Jul-Aug.[PUBMED Abstract]

Steele GD, Herndon JE, Burgess AM, et al.: Sphincter sparing treatment for distal rectal adenocarcinoma: a phase II intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A908, 256a, 1997.

Related Publications

Greenberg JA, Shibata D, Herndon JE 2nd, et al.: Local excision of distal rectal cancer: an update of cancer and leukemia group B 8984. Dis Colon Rectum 51 (8): 1185-91; discussion 1191-4, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Glenn Steele, MD, PhD, Protocol chair
Ph: 570-271-6168

Eastern Cooperative Oncology Group

Al Benson, MD, FACP, Protocol chair
Ph: 312-695-6180

Radiation Therapy Oncology Group

Anthony Russell, MD, FACR, Protocol chair (Contact information may not be current)
Ph: 916-454-6699 ext. 80382

Southwest Oncology Group

George Thomas Budd, MD, Protocol chair
Ph: 216-444-6480; 800-862-7798

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.