MDACC Study Summary RTOG0848 (Archived)

Study Summary
No. RTOG0848:.......Gastrointestinal......Christopher H. Crane......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG0848

Study Title:	A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

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:	The Radiation Therapy Oncology Group

Phase of Study:	Phase III	Return Visit:

Treatment Agents:	Capecitabine Erlotinib Gemcitabine	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Primary Objectives

To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy improves survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process).
To determine whether the use of concurrent fluoropyrimidine and radiotherapy following

adjuvant gemcitabine based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy.

Secondary Objectives

To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and

concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 cycles of adjuvant chemotherapy.

To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and

without erlotinib for patients with resected head of pancreas adenocarcinoma.

To evaluate the disease-free and overall survival of standard adjuvant treatment with and
without erlotinib for patients with resected head of pancreas adenocarcinoma by wild-type and mutant K-Ras status.
To evaluate adverse events with and without erlotinib for patients with resected head of
pancreas adenocarcinoma.
To evaluate adverse events of adjuvant chemotherapy ą radiation therapy and concurrent
fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy.
To evaluate preoperative cross-sectional imaging of the primary head of pancreas
adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present.
To determine the predictive roles of K-Ras mutations and epithelial to mesenchymal transition (EMT) phenotype in response to epidermal growth factor receptor (EGFR) tyrosine kinase inhibition in early-stage pancreas cancer.
To determine the frequency of EGFR activated pathway and its influence on outcome in
patients treated with gemcitabine and/or erlotinib, the association between developmental
molecular markers and outcome of therapy, the phenotype and genotype of tumors in patients with recurrence after resection.
To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy–Fatigue(FACIT-Fatigue), predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival.

Study Status Information



Study Activation / Registration Date:	08/23/2011

IRB Review and Approval Date:	08/23/2011

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	950

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) Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy. Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved. The pathology report must include documentation of the margin status and the size of the tumor. The pathology report must also include the status of the three major margins - bile duct, pancreatic parenchyma, and retroperitoneal (uncinate).

2) Interval between definitive tumor-related surgery and 1st step registration between 21-56 days.

3) Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible. Pathologic reporting using the College of American Pathologists (CAPS) format is strongly encouraged

4) Age >/= 18

5) Zubrod performance status 0 or 1.

6) Complete history and physical examination including weight and Zubrod status within 31 days of study entry.

7) Before starting therapy the patient should be able to maintain adequate oral nutrition of >/= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting.

8) Complete blood count (CBC)/differential obtained within 21 days of registration on study, with adequate bone marrow function defined as follows: *Absolute neutrophil count (ANC) >/= 1,500 cells/mm^3, Platelets >/= 100,000 cells/mm^3, *Hemoglobin >/= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >/= 8.0 g/dl is acceptable.)

9) Post resection serum CA19-9 </= 180 units/mL within 21 days of registration on study.

10) Patients must have: *Serum total bilirubin </= twice the institutional upper limit of normal within 21 days of registration on study. *Creatinine levels </= twice the institutional upper limit of normal within 21 days of registration on study. *Serum glutamic oxaloacetic transaminase (SGOT) must be </= 2.5 x the institutional upper limit of normal within 21 days of registration on study.

11) Negative serum pregnancy test for women of childbearing potential within 14 days of study registration.

12) Abdominal/pelvic computed tomography (CT) scan with contrast and chest CT/x-ray (CT of chest preferred) within 31 days of registration on study. Patients allergic to IV contrast can have MRI of the abdomen/pelvis instead.

13) Signed study-specific informed consent

14) Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol.

15) Women of childbearing potential and male participants must practice adequate contraception.

16) Patients with active human immunodeficiency virus (HIV) infection are eligible if their CD4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active antiretroviral therapy (HAART) is allowed.

Exclusion Criteria:

1) Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.

2) Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy.

3) Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable.

4) Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

5) Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (Patients with a previous history of carcinoma in situ are eligible.

6) Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. *Transmural myocardial infarction within the 3 months of study registration. *Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. *Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

7) Pregnant or lactating women

8) Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

9) If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible.

Links

Registration Number: NCT01013649
Study Information on Clinical Trials Registry (clinicaltrials.gov)