Pancreatic Cancer
Conditions
Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer
Brief summary
To seek preliminary evidence of antitumor activity (progression free survival) of Erlotinib in combination with standard adjuvant chemoradiation and chemotherapy in patients with resected adenocarcinoma of the pancreas.
Detailed description
This study is a phase II trial of erlotinib in combination with chemoradiation in patients with stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. This study is a phase II trial of erlotinib in combination with chemoradiation in patients with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for capecitabine and erlotinib was amended after considering the toxicity profile of the first 6 patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus daily erlotinib 100 mg. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off) and External Beam Radiation Therapy (EBRT) to the tumor bed plus adjacent lymph nodes at doses of 50.4 Gy in 28 fractions after surgery. For patients with close or positive margins after resection, they will be able to receive 54.0 Gy over 30 fractions. Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15 every 28 days plus erlotinib 100 mg/daily.
Interventions
DRUGerlotinib hydrochloride
Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Resection of a stage I/II pancreatic adenocarcinoma of the pancreas (R0/R1) and a candidate to receive postoperative adjuvant chemoradiation. R2 (laparoscopic resection) based on the surgeons operative note will be excluded from the study. 2. Aged 18 years or older. 3. ECOG performance status \< 1. 4. The effects of Erlotinib and Capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5. Patients must have normal organ and marrow function. 6. Provision of written informed consent 7. Patients must have a working knowledge of English in order to complete the quality of life questionnaires. Patients that do not meet this requirement will be exempt from the QoL assessment, but remain eligible for all other components of the study.
Exclusion criteria
1. Known severe hypersensitivity to Erlotinib any of the excipient of this product. Hypersensitivity to Capecitabine, doxifluridine, or 5-FU. 2. Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, non-invasive early stage bladder cancer (\<T1), and cervical cancer in situ. 3. Uncontrolled, intercurrent illness including (but not limited to) ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort. Careful monitoring of PT/INR must be done for patients taking Warfarin. 5. Incomplete healing from previous oncologic or other major surgery. 6. Gastrointestinal tract disease resulting in an inability to take oral medication. 7. Pregnant women are excluded from this study because Erlotinib is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Erlotinib, breastfeeding should be discontinued if the mother is treated with Erlotinib. Capecitabine is also potentially teratogenic and its metabolites can be found in breast milk. 8. Patients with known AIDS or who are HIV-positive on anti-retroviral therapy are excluded since patients' immune deficiency are at increased risk of lethal infection when treated with marrow-suppressive therapy, and interactions between Erlotinib and anti-retroviral therapy are unknown. If patients have known risk factors of HIV they should be tested based on the discretion of the treating oncologist. 9. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded). 10. Previous radiation to the abdomen. 11. Previous chemotherapy for pancreatic cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival | Up to 3 years | Time from surgery to recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | up to 3 years | Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile. |
| Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Up to 3 months after completion of maintenance chemotherapy | Quality of life (QOL) was assessed before chemoradiation therapy (CRT) was started or during the first week of its administration \[baseline (BL)\], between completion of CRT and starting maintenance chemotherapy \[time 1 (t1)\], and within 3 months after completion of maintenance chemotherapy \[time 2 (t2)\]. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses quality of life on three domains: symptoms (score ranges from 7-14); function (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes. |
| Change in QoL as Assessed by QLQ-PAN 26 | 3 months | Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline \[BL\]), between completion of CRT and starting maintenance chemotherapy (time 1 \[t1\]), and within 3 months after completion of maintenance chemotherapy (time 2 \[t2\]). QLQ-PAN 26 questionnaire includes 26 questions, organized into 7 scales, with scores for each ranging from 0-100. Higher scores indicate worse health state. Therefore, decreasing (negative) scores indicate a better outcome. |
| Time to Death as Assessed by Median Overall Survival (Months) | up to 5 years | — |
Countries
United States
Participant flow
Recruitment details
All patients enrolled at Johns Hopkins
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib and EBRT After Pancreatectomy All patients received RT, Erlotinib and Capecitabine, followed by gemcitabine/erlotinib | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Erlotinib and EBRT After Pancreatectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 48 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 48 |
| other Total, other adverse events | 31 / 48 |
| serious Total, serious adverse events | 16 / 48 |
Outcome results
Primary
Recurrence Free Survival
Time from surgery to recurrence
Time frame: Up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib and EBRT After Pancreatectomy | Recurrence Free Survival | 15.6 months |
Secondary
Change in QoL as Assessed by QLQ-PAN 26
Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline \[BL\]), between completion of CRT and starting maintenance chemotherapy (time 1 \[t1\]), and within 3 months after completion of maintenance chemotherapy (time 2 \[t2\]). QLQ-PAN 26 questionnaire includes 26 questions, organized into 7 scales, with scores for each ranging from 0-100. Higher scores indicate worse health state. Therefore, decreasing (negative) scores indicate a better outcome.
Time frame: 3 months
Population: QoL data was only available for 33 participants. Paired data for time 1 was only available for 30/33 participants, and only 20/33 participants at time 2.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Pancreatic Pain (t1 vs. BL) | -1.9 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Pancreatic Pain (t2 vs. BL) | -3.8 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Pancreatic Pain (t2 vs. t1) | 2.4 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Digestive (t1 vs. BL) | -0.9 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Digestive (t2 vs. BL) | -4.6 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Digestive (t2 vs. t1) | -1.4 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Altered Bowel Habits (t2 vs. t1) | -4.9 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Jaundice (t1 vs. BL) | -1.3 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Jaundice (t2 vs. BL) | -2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Jaundice (t2 vs. t1) | 0 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Body Image (t1 vs. BL) | -6.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Body Image (t2 vs. BL) | -3.1 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Body Image (t2 vs. t1) | -0.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Satisfaction with healthcare (t1 vs. BL) | 4.1 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Satisfaction with health care (t2 vs. BL) | 3.1 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Satisfaction with health care (t2 vs. t1) | 0 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Sexual function (t1 vs. BL) | -0.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Sexual function (t2 vs. BL) | 14.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Altered Bowel Habits (t1 vs. BL) | 14.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Altered Bowel Habits (t2 vs. BL) | 7.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in QoL as Assessed by QLQ-PAN 26 | Sexual function (t2 vs. t1) | 14.1 score on a scale |
Secondary
Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)
Quality of life (QOL) was assessed before chemoradiation therapy (CRT) was started or during the first week of its administration \[baseline (BL)\], between completion of CRT and starting maintenance chemotherapy \[time 1 (t1)\], and within 3 months after completion of maintenance chemotherapy \[time 2 (t2)\]. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses quality of life on three domains: symptoms (score ranges from 7-14); function (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.
Time frame: Up to 3 months after completion of maintenance chemotherapy
Population: QoL data was only available for 33 participants. Paired data for time 1 was only available for 30/33 participants, and only 20/33 participants at time 2.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Global (Time 2 vs. BL) | -1.8 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Global (Time 2 vs. Time 1) | 4.6 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Functional (F) - Physical (Time 1 vs. BL) | 0.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Physical (Time 2 vs. BL) | -3.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Physical (Time 2 vs. Time 1) | -6.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Role (Time 1 vs. BL) | -3.1 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Role (Time 2 vs. BL) | -0.3 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Role (Time 2 vs. Time 1) | -4.4 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Cognition (Time 1 vs. BL) | -2.6 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Cognition (Time 2 vs. BL) | 1.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Cognition (Time 2 vs. Time 1) | -1.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Emotional (Time 1 vs. BL) | -0.4 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Global (Time 1 vs. BL) | 1 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Emotional (Time 2 vs. BL) | 2.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Emotional (Time 2 vs. Time 1) | -0.6 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Social (Time 1 vs. BL) | 3.9 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Social (Time 2 vs. BL) | 4.4 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | F - Social (Time 2 vs. Time 1) | -3.8 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Financial (Time 1 vs. BL) | 1.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Financial (Time 2 vs. BL) | 2.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | Financial (Time 2 vs. Time 1) | 0 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | General Symptoms (GS) - Fatigue (Time 1 vs. BL) | 5.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Fatigue (Time 2 vs. BL) | 5.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Fatigue (Time 2 vs. Time 1) | 1.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Nausea/Vomiting (Time 1 vs. BL) | 2.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Nausea/Vomiting (Time 2 vs. BL) | 0 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Nausea/Vomiting (Time 2 vs. Time 1) | 1.9 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Pain (Time 1 vs. BL) | 2.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Pain (Time 2 vs. Time 1) | 5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Dyspnea (Time 1 vs. BL) | 1.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Dyspnea Time 2 vs. BL) | 3.8 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Dyspnea (Time 2 vs. Time 1) | 1.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Insomnia (Time 1 vs. BL) | -2.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Insomnia (Time 2 vs. BL) | 0 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Insomnia (Time 2 vs. Time 1) | 2.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Appetite Loss (Time 1 vs. BL) | -2.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Appetite Loss (Time 2 vs. BL) | -15 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Appetite Loss (Time 2 vs. Time 1) | -5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Constipation (Time 1 vs. BL) | -4.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Constipation (Time 2 vs. BL) | -2.5 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Constipation (Time 2 vs. Time 1) | 0 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Diarrhea (Time 1 vs. BL) | 14.7 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Diarrhea (Time 2 vs. BL) | 8.8 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Diarrhea (Time 2 vs. Time 1) | -6.2 score on a scale |
| Erlotinib and EBRT After Pancreatectomy | Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0) | GS - Pain (Time 2 vs. BL) | 7.2 score on a scale |
Secondary
Number of Participants Experiencing Adverse Events
Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile.
Time frame: up to 3 years
Population: 39/48 total participants received maintenance chemotherapy after chemoradiation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erlotinib and EBRT After Pancreatectomy | Number of Participants Experiencing Adverse Events | Grade 2 | 24 Participants |
| Erlotinib and EBRT After Pancreatectomy | Number of Participants Experiencing Adverse Events | Grade 3 | 15 Participants |
| Erlotinib and EBRT After Pancreatectomy | Number of Participants Experiencing Adverse Events | Grade 4 | 1 Participants |
| Adjuvant Gemcitabine Plus Erlotinib | Number of Participants Experiencing Adverse Events | Grade 2 | 15 Participants |
| Adjuvant Gemcitabine Plus Erlotinib | Number of Participants Experiencing Adverse Events | Grade 3 | 14 Participants |
| Adjuvant Gemcitabine Plus Erlotinib | Number of Participants Experiencing Adverse Events | Grade 4 | 3 Participants |
Secondary
Time to Death as Assessed by Median Overall Survival (Months)
Time frame: up to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib and EBRT After Pancreatectomy | Time to Death as Assessed by Median Overall Survival (Months) | 24.39 months |