Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613469
Recruitment Status : Unknown
Verified April 2015 by Marks, John, M.D..
Recruitment status was:  Recruiting
First Posted : June 7, 2012
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):
Marks, John, M.D.

June 5, 2012
June 7, 2012
April 3, 2015
August 2011
August 2017   (Final data collection date for primary outcome measure)
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer. [ Time Frame: One year from the time of chemoradiation ]
Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.
Same as current
Complete list of historical versions of study NCT01613469 on Archive Site
The proportion of subjects with complete pathological response at surgical resection [ Time Frame: One year from chemoradiation therapy ]
At surgical intervention for incomplete clinical response or recurrence, complete pathological response is no evidence of residual disease at pathological examination of the resected specimen.
Same as current
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Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.
Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of 5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good success in achieving complete clinical response, avoiding surgical intervention. If at follow-up remaining disease is found or if there is recurrent disease, surgery can be performed.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rectal Neoplasms
  • Drug: 5FU/Leucovorin
    450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles during radiation (one cycle is the administration every day for 3 consecutive days, a cycle is 21 days)followed by 450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles after completion of radiation.
  • Radiation: external beam photon radiation
    45 Gy in 25 fractions (1.8Gy per fraction, 5 fractions per week)over 5 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2017
August 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • over 18 years old
  • tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
  • clinical/radiological stages T2,T3,or T4, N0-1
  • ANC >1500, PLT>100,000
  • AST and alkaline phosphatase < 2.5 X ULN
  • bilirubin < 1.5 X ULN
  • CrCl > 50 ml/min using Cockcroft-Gault formula
  • KPS >60
  • ECOG Performance Scale 0-2
  • No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer
  • no evidence of metastatic disease

Exclusion Criteria:

  • initial tumor fixation to pelvic bone or side wide; technically unresectable disease
  • any evidence of distant metastasis
  • perforation
  • obstruction
  • hereditary non-polyposis colorectal cancer
  • synchronous primary colon carcinomas except T1 lesions
  • known dihydropyrimidine dehydrogenase deficiency
  • prior radiation therapy to the pelvis
  • prior chemotherapy for malignancies
  • known existing uncontrolled coagulopathy
  • pregnancy or lactation
  • women of childbearing potential not using reliable and appropriate contraceptive method
  • serious, uncontrolled concurrent infection(s)
  • participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • clinically significant heart disease
  • other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion)
  • major surgery within 4 weeks prior to the study treatment
  • lack of physical integrity of the upper GI tract or malabsorption syndrome
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Marks, John, M.D.
Marks, John, M.D.
Not Provided
Principal Investigator: John Marks, MD Main Line Health
Marks, John, M.D.
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP