A phase III trial evaluating both erlotinib and chemoradiation as adjuvant treatment for patients withresected head of pancreas adenocarcinoma.

• Conditions: Patients with resected head of pancreas adenocarcinoma; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 14.1Level: PTClassification code 10052747Term: Adenocarcinoma pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-000618-20-ES
• Lead Sponsor: EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 950

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 nmust 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.
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. 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/mm3
- Platelets ? 100,000 cells/mm3
- 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.
- 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 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 HIV infection are eligible if their CD4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of HAART is allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 as 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified