MDACC Study Summary SWOG0809 (Archived)

Study Summary
No. SWOG0809:.......Gastrointestinal......Christopher H. Crane......Radiation Oncology

Study Summary Title



Study Summary Number:	SWOG0809

Study Title:	A PhaseII Trial Of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy In Extrahepatic Cholangiocarcinoma (EHCC)

Physician

New Patient Referral



Name:	Christopher H. Crane	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal	Supported By:	Southwest Oncology Group

Phase of Study:	Phase I/Phase II	Return Visit:

Treatment Agents:	Capecitabine Gemcitabine Radiotherapy	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of EHCC patients treated with adjuvant capecitabine/gemcitabine followed by capecitabine and radiotherapy.

To estimate the 2-year stratum-specific and overall disease-free survival and local disease-free survival attained with this regimen.

To assess the frequency and severity of toxicity associated with this regimen.

Study Status Information



Study Activation / Registration Date:	06/16/2010

IRB Review and Approval Date:	06/16/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	80

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient must have a histopathological diagnosis of extrahepatic cholangiocarcinoma (gallbladder or bile duct).

2) Patient must have at least one of the following: a) pathological T2-4 disease b) pathological N1 disease c) positive margins (any T or N stage)

3) Patient must have received a potentially curative radical resection with negative (R0) or microscopically positive (R1) margins. Resection must have been performed within 56 days prior to registration and patient must have recovered from any complications.

4) Patient must have adequate bone marrow function as defined by absolute neutrophil count > 1,500/mcl and platelets > 100,000/mcl, obtained within 28 days prior to registration.

5) Patient must have adequate renal function as defined by serum creatinine < 1.5 mg/dl obtained within 28 days prior to registration.

6) Patient must have adequate hepatic function as defined by total bilirubin < 1.5 x the institutional upper limit of normal (IULN) and either SGOT or SGPT < 2.5 x IULN, obtained within 28 days prior to registration.

7) Patient must have a Zubrod performance status of 0 - 1

8) Specimens must be available to be submitted for pathology review. Sites must seek additional patient consent for the use of tissue for future research.

9) Patient must be able to swallow enteral medications.

10) All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

11) At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.

Exclusion Criteria:

1) Patient must not have ampullary cancer.

2) Patient must not have distant metastatic disease as indicated by a CT or MRI of the chest, abdomen, and pelvis within 42 days prior to registration. Positive resected regional lymph nodes are allowed.

3) Patient must not have received any prior chemotherapy or radiotherapy for this disease.

4) Patient must have had no previous upper abdominal radiation therapy for any reason at any time.

5) Patient must not require feeding tube. Patient must not have intractable nausea or vomiting, GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).

6) Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of myocardial infarction or cerebrovascular accident within 3 months prior to registration, uncontrolled diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements.

7) Patients must not be pregnant or nursing because of the risk of fetal or nursing infant harm. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.

8) No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer from which the patient has been disease-free for five years.

Links

Registration Number: NCT00789958
Study Information on Clinical Trials Registry (clinicaltrials.gov)