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Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Phase 2
18 Years
Open (Enrolling)
Rectal Neoplasms

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Trial Information

Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.

Outcome Description:

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.

Outcome Time Frame:

One year from the time of chemoradiation

Safety Issue:


Principal Investigator

John Marks, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Main Line Health


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

August 2014

Related Keywords:

  • Rectal Neoplasms
  • fluorouracil
  • leucovorin
  • radiotherapy
  • neoadjuvant therapy
  • Neoplasms
  • Rectal Neoplasms



Lankenau Medical Center Wynnewood, Pennsylvania  19096