Pancreatic CancerPhase 2NCT00026403
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 study testing cisplatin, gemcitabine hydrochloride and radiation therapy in people with Pancreatic Cancer, run by Alliance for Clinical Trials in Oncology at 26 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- cisplatin, gemcitabine hydrochloride and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Sep 2001to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed unresectable adenocarcinoma of the pancreas
- No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
- Prior subtotal resection or gross residual disease
- No microscopic residual disease only
- No metastatic disease outside of planned study radiotherapy field
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to maintain adequate oral nutrition
- No significant infection
- No other medical condition that would preclude study
- No other malignancy within the past 5 years except non-melanoma skin cancer
- No significant nausea or vomiting
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior or concurrent biologic therapy
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy that would overlap planned study radiotherapy fields
Surgery:
- See Disease Characteristics
- At least 21 days since prior laparotomy
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
Medcenter One Health System
Bismarck, North Dakota, 58501-5505
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Altru Cancer Center
Grand Forks, North Dakota, 58201
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
CCOP - Ochsner
New Orleans, Louisiana, 70121
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
CentraCare Health Plaza
Saint Cloud, Minnesota, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.
- Conditions
- Pancreatic Cancer
- Being tested
- cisplatin, gemcitabine hydrochloride, radiation therapy
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy + gemcitabine + cisplatin | Experimental | Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Receives: Drug: cisplatin; Drug: gemcitabine hydrochloride; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 12 months
Secondary outcomes (1)
quality of life
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2001
- Primary completionJun 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael G. Haddock, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026403
- Sponsor's protocol ID
- NCCTG-N9942
- Other IDs
- NCI-2012-02426, CDR0000069026
- Status last verified
- Jul 2016
- First submitted
- 9 Nov 2001
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Haddock MG, Swaminathan R, Foster NR, Hauge MD, Martenson JA, Camoriano JK, Stella PJ, Tenglin RC, Schaefer PL, Moore DF Jr, Alberts SR. Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942. J Clin Oncol. 2007 Jun 20;25(18):2567-72. doi: 10.1200/JCO.2006.10.2111.
PubMed 17577035Haddock MG, Swaminathan R, Alberts SR, et al.: Gemcitabine (Gem), cisplatin (Cis) and radiation therapy (RT) for patients with locally advanced pancreatic adenocarcinoma (ACA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] J Clin Oncol 22 (Suppl 14): A-4121, 343s, 2004.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine, Cisplatin and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00026403
- Acronym / sponsor ID
- NCCTG-N9942
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy + gemcitabine + cisplatin | Experimental | Drug: cisplatin, Drug: gemcitabine hydrochloride, Radiation: radiation therapyPatients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | radiotherapy + gemcitabine + cisplatin |
| gemcitabine hydrochloride | Drug | radiotherapy + gemcitabine + cisplatin |
| radiation therapy | Radiation | radiotherapy + gemcitabine + cisplatin |
Primary outcome
overall survival
Time frame: 12 months
1 secondary outcome
quality of life
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Results publication: PubMed 17577035Haddock MG, Swaminathan R, Foster NR, Hauge MD, Martenson JA, Camoriano JK, Stella PJ, Tenglin RC, Schaefer PL, Moore DF Jr, Alberts SR. Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942. J Clin Oncol. 2007 Jun 20;25(18):2567-72. doi: 10.1200/JCO.2006.10.2111.
- Results publicationHaddock MG, Swaminathan R, Alberts SR, et al.: Gemcitabine (Gem), cisplatin (Cis) and radiation therapy (RT) for patients with locally advanced pancreatic adenocarcinoma (ACA): a North Central Cancer Treatment Group (NCCTG) phase II study. [Abstract] J Clin Oncol 22 (Suppl 14): A-4121, 343s, 2004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G. Haddock, MD study chair
Mayo Clinic
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, gemcitabine hydrochloride and radiation therapy in people with Pancreatic Cancer, run by Alliance for Clinical Trials in Oncology at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.