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Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Marks, John, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613469
First Posted: June 7, 2012
Last Update Posted: April 3, 2015
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.
Information provided by (Responsible Party):
Marks, John, M.D.
  Purpose
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.

Condition Intervention Phase
Rectal Neoplasms Drug: 5FU/Leucovorin Radiation: external beam photon radiation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Further study details as provided by Marks, John, M.D.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 35
Study Start Date: August 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613469


Contacts
Contact: John Marks, MD 610-645-9093

Locations
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: John Marks, MD    610-645-9093      
Principal Investigator: John Marks, MD         
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: John Marks, MD    610-645-9093      
Sponsors and Collaborators
Marks, John, M.D.
Investigators
Principal Investigator: John Marks, MD Main Line Health
  More Information

Publications:
Responsible Party: Marks, John, M.D.
ClinicalTrials.gov Identifier: NCT01613469     History of Changes
Other Study ID Numbers: R12-3092L
First Submitted: June 5, 2012
First Posted: June 7, 2012
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Marks, John, M.D.:
fluorouracil
leucovorin
radiotherapy
neoadjuvant therapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases


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