Lung CancerPhase 3NCT00003317
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
A Phase 3 study testing carboplatin, paclitaxel and radiation therapy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 16 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, paclitaxel 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
- 480 participants
- Where
- 16 sitesUnited States
- Study dates
- May 1998to Aug 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed stage IIIA non-small cell lung cancer that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video assisted resection is acceptable) No known residual disease present Involvement in N2 nodes must have been determined only at the time of surgical exploration or by postoperative pathologic diagnosis All grossly involved nodes must be removed at surgery No positive mediastinoscopy (if lymph nodes on CT scan are greater than 1.5 cm in diameter, mediastinoscopy is required)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ZUBROD 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors Chemotherapy: No prior chemotherapy for non-small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure Hormones for nondisease related conditions Dexamethasone as an antiemetic Radiation therapy: No prior radiotherapy for non-small cell lung cancer Surgery: See Disease Characteristics
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, 58501
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
CCOP - Duluth
Duluth, Minnesota, 55805
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Altru Health Systems
Grand Forks, North Dakota, 58201
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
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, 57105-1080
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: A Phase III Study of Surgical Resection and Chemotherapy (Paclitaxel and Carboplatin) With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.
Read the detailed description
OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. II. Compare failure free survival of these patients. III. Describe the patterns of local and distant recurrence in these patients. IV. Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, paclitaxel, radiation therapy, surgery
- Keywords
- stage IIIA non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
paclitaxelDrug
radiation therapyRadiation
surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery + paclitaxel + carboplatin | Active comparator | Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Receives: Drug: carboplatin; Drug: paclitaxel; Procedure: surgery |
| Surgery + paclitaxel + carboplatin + radiotherapy | Experimental | Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Receives: Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 5 years
Disease-free survival
Measured: Up to 5 years
Patterns of local and distant recurrence in these patients
Measured: Up to 5 years
Toxicities associated with chemotherapy with or without adjuvant radiotherapy in patients.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2004 (estimated)
- Study startMay 1998
- Primary completionJun 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 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
- Leslie J. Kohman, MD, Study chair, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003317
- Sponsor's protocol ID
- CALGB-9734
- Other IDs
- U10CA031946, CDR0000066266
- Status last verified
- Jul 2016
- First submitted
- 1 Nov 1999
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Perry MC, Kohman LJ, Bonner JA, Gu L, Wang X, Vokes EE, Green MR. A phase III study of surgical resection and paclitaxel/carboplatin chemotherapy with or without adjuvant radiation therapy for resected stage III non-small-cell lung cancer: Cancer and Leukemia Group B 9734. Clin Lung Cancer. 2007 Jan;8(4):268-72. doi: 10.3816/CLC.2007.n.005.
PubMed 17311692
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Surgical Resection and Chemotherapy (Paclitaxel and Carboplatin) With or Without Adjuvant Radiotherapy for Resected Stage IIIA Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00003317
- Acronym / sponsor ID
- CALGB-9734
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- Jun 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 24 Jun 2004 (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 more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.
Detailed description
OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. II. Compare failure free survival of these patients. III. Describe the patterns of local and distant recurrence in these patients. IV. Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery + paclitaxel + carboplatin | Active comparator | Drug: carboplatin, Drug: paclitaxel, Procedure: surgeryFour to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are followed at least every 4 months for 2 years, then every 6 months thereafter. |
| Surgery + paclitaxel + carboplatin + radiotherapy | Experimental | Drug: carboplatin, Drug: paclitaxel, Radiation: radiation therapy, Procedure: surgeryFour to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| carboplatin | Drug | Surgery + paclitaxel + carboplatin, Surgery + paclitaxel + carboplatin + radiotherapy |
| paclitaxel | Drug | Surgery + paclitaxel + carboplatin, Surgery + paclitaxel + carboplatin + radiotherapy |
| radiation therapy | Radiation | Surgery + paclitaxel + carboplatin + radiotherapy |
| surgery | Procedure or surgery | Surgery + paclitaxel + carboplatin, Surgery + paclitaxel + carboplatin + radiotherapy |
Primary outcome
Overall survival
Time frame: Up to 5 years
Disease-free survival
Time frame: Up to 5 years
Patterns of local and distant recurrence in these patients
Time frame: Up to 5 years
Toxicities associated with chemotherapy with or without adjuvant radiotherapy in patients.
Time frame: Up to 5 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 13 Jul 2016.
- Results publication: PubMed 17311692Perry MC, Kohman LJ, Bonner JA, Gu L, Wang X, Vokes EE, Green MR. A phase III study of surgical resection and paclitaxel/carboplatin chemotherapy with or without adjuvant radiation therapy for resected stage III non-small-cell lung cancer: Cancer and Leukemia Group B 9734. Clin Lung Cancer. 2007 Jan;8(4):268-72. doi: 10.3816/CLC.2007.n.005.
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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.
Leslie J. Kohman, MD study chair
State University of New York - Upstate Medical University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, paclitaxel and radiation therapy in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 16 sites in United States.
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 13 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 16 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Up to 5 years). The study lists 4 primary outcomes in all. 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 NCT00003317, which also lists 1 linked publication.
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 13 Jul 2016.