Stage III Rectal Cancer Clinical Trial
Official title:
A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
Verified date | February 2019 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 90 days | |
Secondary | 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. | 9 to 11 weeks |
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