Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy and FOLFOX Chemotherapy for Rectal Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Rectal Cancer

In brief

Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy given with chemotherapy at the same time. External beam radiation can increase side effects both short and long-term by exposing normal tissue nearby the tumor such as the bladder, bowel and sexual organs. Instead, this study will use a different way of delivering radiation called brachytherapy to decrease normal tissue radiation exposure. Patient will be given three chemotherapy medications both before and after surgery: oxaliplatin (also called EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic Acid). The purpose of this study is to find out whether giving chemotherapy and brachytherapy before surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of tumor recurrence 3) avoid patient having the side effects related to chemotherapy and external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.

Key facts

Study ID

NCT01659424

Run by

Beth Israel Medical Center

People needed

0

Starts

2011-06-01

Expected to finish

2014-11-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the rectum
• T2/3 tumors at ≤ 12cm from the A-V margin (below the peritoneal reflection)
• Tumors with a lumen to allow the positioning of the rectal applicator.
• Tumor of less than 3.5cm thickness documented at the CT Simulator
• Patient should be a suitable candidate for surgery and chemotherapy
• ECOG/WHO performance status 0-1
• Age 18 or older
• No previous history of pelvic radiation or chemotherapy
• Adequate marrow reserve, with absolute neutrophil count greater than or equal to 1.5 x 109/L and platelets greater than or equal to 100 x 109/L.
• Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN
• Non pregnant, non-lactating females under active contraception
• No peripheral neuropathy > grade 2

You may not qualify if…

• Evidence of necrotic pelvic nodes or ≥ 1 cm
• Evidence of distant metastasis
• Previous pelvic radiation
• Other cancer except for non-melanomatous carcinoma of the skin or CIS of the cervix.
• Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
• Use of any investigational agent within the 4 weeks preceding enrolment
• Exposure to chemotherapy during the neoadjuvant phase
• Documented distant metastases
• Significant neuropathy
• History of allergic reactions to platin compounds or 5-FU or leucovorin
• Uncontrolled intercurrent illness such as active infection, congestive heart failure or coronary artery disease.
• Psychiatric illness that would limit compliance with study requirements
• Pregnancy or lactation
• HIV infection

Where it is running

• Beth Isael Medical Center — New York, New York, United States
• St-Lukes Roosevelt Hospital Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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