Trial Outcomes & Findings for Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer (NCT NCT00068575)
NCT ID: NCT00068575
Last Updated: 2012-02-15
Results Overview
Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Participants followed till disease progression or death (approximately 6 years)
Results posted on
2012-02-15
Participant Flow
Recruitment Period: May 31, 2002 to January 14, 2010. All recruitment was done at UT MD Anderson Cancer Center.
Of the 29 participants who were enrolled, one patient dropped out prior to receiving study treatment.
Participant milestones
| Measure |
Postoperative Chemoradiation Regimen
Postoperative Cisplatin 30 mg/m\^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
|
|---|---|
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Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Postoperative Chemoradiation Regimen
n=28 Participants
Postoperative Cisplatin 30 mg/m\^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
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|---|---|
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Age Continuous
|
60.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Participants followed till disease progression or death (approximately 6 years)Population: Analysis by protocol.
Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.
Outcome measures
| Measure |
Postoperative Chemoradiation Regimen
n=28 Participants
Postoperative Cisplatin 30 mg/m\^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
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|---|---|
|
Median Overall Survival (OS)
|
42 months
Interval 32.1 to 64.5
|
Adverse Events
Postoperative Chemoradiation Regimen
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Postoperative Chemoradiation Regimen
n=28 participants at risk
Postoperative Cisplatin 30 mg/m\^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
|
|---|---|
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Blood and lymphatic system disorders
Leukopenia
|
53.6%
15/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
12/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Infections and infestations
Febrile (Non-neutropenic)
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Metabolism and nutrition disorders
Elevated alkaline phosphate
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Metabolism and nutrition disorders
Elevated Alanine transaminase (ALT)
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
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Investigations
Abdominal Pain
|
7.1%
2/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
General disorders
Fatigue
|
28.6%
8/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Skin and subcutaneous tissue disorders
Hand/foot syndrome
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Gastrointestinal disorders
Anorexia
|
28.6%
8/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Gastrointestinal disorders
Dehydration
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
7.1%
2/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
32.1%
9/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
General disorders
Abdominal abscess
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
|
Investigations
Overdose of interferon alfa-2b (IFN)
|
3.6%
1/28 • Toxicity assessed for participants while on 6 week chemoradiation treatment period with a one week break (equivalent 7 weeks). Data collected over 7 years and 4 months through on-going follow up.
Only adverse events during treatment for Common Toxicity Criteria (CTC) Grade 3 events and above were collected. Toxicities graded by the National Cancer Institute (NCI) 1998 CTC.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place