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

NCT01659424 | Withdrawn Phase 2

• 1 other identifier: HDRBT for Rectal cancer
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer

Outcome Measures

Primary Outcomes (1)

• Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) Improve Compliance

  Investigator propose combining pre-operative FOLFOX chemotherapy with high dose rate endorectal brachytherapy followed by surgery and then additional FOLFOX chemotherapy to further improve compliance.

  five years

Secondary Outcomes (4)

• Locoregional failure

  5 years

• Distant Metastasis

  5 years

• Toxicity

  1 year

• 4) Quality of Life

  5 year

Study Arms (1)

Single Arm

OTHER

This is a single arm study.

Radiation: High Dose Rate Endorectal Brachytherapy (HDR-ERBT)

Interventions

High Dose Rate Endorectal Brachytherapy (HDR-ERBT) RADIATION

Combining pre-operative FOLFOX chemotherapy with HDR-ERBT (Radiation therapy) followed by surgery then additional FOLFOX chemotherapy to decrease the risk of distant metastasis and to maintain excellent locoregional control with decreased morbidity.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Beth Israel Medical Center: lead
• St. Luke's-Roosevelt Hospital Center: collaborator

Study Sites (2)

Beth Isael Medical Center

New York, New York, 10003, United States

Location

St-Lukes Roosevelt Hospital Medical Center

New York, New York, 10018, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kenneth Hu, MD

  Beth Israel Medical Center NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: August 7, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (2)