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Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

Primary Purpose

Stage II Rectal Cancer, Stage III Rectal Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capecitabine
5-FU
Leucovorin
Oxaliplatin
radiation
total mesorectal excision
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II Rectal Cancer focused on measuring rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed study-specific informed consent form
  2. Age > 18 years old
  3. Zubrod performance status 0-1
  4. Biopsy proven primary malignancy
  5. AJCC Stage II or III disease (T3-4 and/or N1-2 disease) as determined by endoscopic ultrasound and/or MRI staging
  6. Pretreatment rectal endoscopic ultrasound and pelvic MRI, colonoscopy, CT of chest, abdomen, and pelvis, and laboratory values as discussed below

Exclusion Criteria:

  1. History of inflammatory bowel disease
  2. Previous pelvic radiotherapy
  3. A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process.
  4. Men and women of reproductive potential must agree to use an effective contraception method
  5. Pregnant or lactating women

  6. Severe, active co-morbidity, defined as

    • Unstable angina and/or CHF requiring hospitalization within the last six months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  7. Presence of metastatic disease, including liver metastases
  8. Laboratory values out of range

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

arm one

Arm Description

RT + Chemo + surgery

Outcomes

Primary Outcome Measures

The primary study endpoint for the phase I portion of this study is to assess surgical complications through the Clavien grading system.
The adverse events will be followed prospectively from the date of surgery for 90 days. Dose-limiting toxicity (DLT) will be defined as > grade 3 anastomotic stricture or leak, infection (including pelvic abscess or wound infection), small bowel obstruction, or fistualization. Any other post-operative complication thought related directly to the surgical intervention that is a grade 3 or higher Clavien complication will also be considered dose-limiting toxicity.

Secondary Outcome Measures

The primary endpoint of the phase II portion of the study is complete pathologic response.
9 to 11 weeks after the completion of the initial chemoradiotherapy.

Full Information

First Posted
February 21, 2011
Last Updated
August 19, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01302613
Brief Title
Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
Official Title
A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Drug shortage
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the pilot portion of this study is to establish the safety and tolerability of an extended treatment break period in patients who have undergone neoadjuvant chemoradiotherapy as well as use of systemic therapy during this break.
Detailed Description
The proposed protocol aims to continue tumor-directed therapy during the typical "break period" in an effort to improve on both local tumor response as well as distant disease control. First, the duration from completion of chemoradiotherapy would increase from 6-8 weeks to 9-11 weeks. As noted above, this may allow for further cell death with resultant pathologic downstaging. Secondly, the protocol calls for continued systemic therapy during the 9-11 week period, thus allowing continuation of therapies directed towards both the primary as well as distant sites of disease. The primary aim of this pilot study would be to establish the feasibility of this intensified neoadjuvant approach, especially with respect to tolerability of the subsequent pelvic surgery. A subsequent phase II portion will evaluate the efficacy of this treatment approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Rectal Cancer, Stage III Rectal Cancer
Keywords
rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm one
Arm Type
Other
Arm Description
RT + Chemo + surgery
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine will be delivered concurrently with the radiation therapy, at a dose of 1650 mg/m2 divided in even BID doses. It will only be taken on the days of radiation treatment (Monday-Friday, except for holidays). The A.M. dose of the capecitabine must be taken at least one hour prior to the radiation treatment.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
5-FU 400 mg/m2, iv bolus on day 1 followed by 2400 mg/m2 iv over 46 hours of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Leucovorin 400 mg/m2, IV, over 2 hours before 5-FU on day 1 of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 85mg/m2 IV on day 1 of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
28-30 fractions of radiation, given once a day, five days per week (Monday-Friday, except for holidays). The prescribed fraction dose is 180 cGy; the total radiation dose is thus 5040-5400 cGy. The primary treatment fields will be treated with 25 fractions of 180 cGy/fraction with a "boost" of 3-5 fractions of 180 cGy subsequently delivered.
Intervention Type
Procedure
Intervention Name(s)
total mesorectal excision
Intervention Description
Optimal surgical technique involving use of total mesorectal excision (TME) is mandated. The type of surgery, either low anterior resection with sparing of the sphincter mechanism or sphincter-eliminating abdominoperineal resection (APR), will be at the discretion of the attending surgeon.
Primary Outcome Measure Information:
Title
The primary study endpoint for the phase I portion of this study is to assess surgical complications through the Clavien grading system.
Description
The adverse events will be followed prospectively from the date of surgery for 90 days. Dose-limiting toxicity (DLT) will be defined as > grade 3 anastomotic stricture or leak, infection (including pelvic abscess or wound infection), small bowel obstruction, or fistualization. Any other post-operative complication thought related directly to the surgical intervention that is a grade 3 or higher Clavien complication will also be considered dose-limiting toxicity.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The primary endpoint of the phase II portion of the study is complete pathologic response.
Description
9 to 11 weeks after the completion of the initial chemoradiotherapy.
Time Frame
9 to 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed study-specific informed consent form Age > 18 years old Zubrod performance status 0-1 Biopsy proven primary malignancy AJCC Stage II or III disease (T3-4 and/or N1-2 disease) as determined by endoscopic ultrasound and/or MRI staging Pretreatment rectal endoscopic ultrasound and pelvic MRI, colonoscopy, CT of chest, abdomen, and pelvis, and laboratory values as discussed below Exclusion Criteria: History of inflammatory bowel disease Previous pelvic radiotherapy A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process. Men and women of reproductive potential must agree to use an effective contraception method Pregnant or lactating women Severe, active co-morbidity, defined as Unstable angina and/or CHF requiring hospitalization within the last six months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Presence of metastatic disease, including liver metastases Laboratory values out of range
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

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