Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

This study is currently recruiting participants.
Verified June 2013 by Marks, John, M.D.
Sponsor:
Information provided by (Responsible Party):
Marks, John, M.D.
ClinicalTrials.gov Identifier:
NCT01613469
First received: June 5, 2012
Last updated: June 11, 2013
Last verified: June 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: August 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 5, 2012
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Levoleucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014