Lung CancerPhase 2NCT00984997
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
A Phase 2 study testing Surgery, Chest Irradiation and Cisplatin in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
1. To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy. 2. To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Surgery, Chest Irradiation and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1993to Jun 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No previous treatment.
- Tumor must be resectable.
- >/= 18 and </= 70 years of age.
- Zubrod performance status </= or higher performance status if based only on pain.
- Must have adequate bone marrow, liver and renal function as defined in 3.6.
Who cannot join
- Cytological or histological proof of N3 disease.
- Evidence of metastatic disease to distant sites.
- Patients with impending cord compression will be ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
- To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy.
- To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.
Read the detailed description
Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy.
Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29.
If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks.
- Conditions
- Lung Cancer
- Keywords
- Superior Sulcus Tumor, Lung Cancer, Non-Small Cell, Multimodality Treatment, Surgery, Segmentectomy, Lobectomy, Cisplatin, CDDP, Etoposide, VP-16, VePesid, Radiation Therapy, Radiotherapy, Chest Irradiation, Prophylactic Cranial Irradiation, PCI
- Medical subject headings
- Lung Neoplasms, Pancoast Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Segmentectomy or lobectomy with en bloc resection of the involved chest.
Chest IrradiationRadiation
Also called Radiotherapy
Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week.
CisplatinDrug
Also called Platinol, CDDP
50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.
EtoposideDrug
Also called VePesid, VP-16
given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29.
Prophylactic Cranial IrradiationRadiation
Also called PCI
25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.
| Study group | Role | What they receive |
|---|---|---|
| Surgery + Radiotherapy + Chemotherapy | Experimental | Surgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy. Segmentectomy or lobectomy with en bloc resection of the involved chest. Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week. Cisplatin 50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.
Etoposide given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29. Prophylactic Cranial Irradiation 25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional. Receives: Procedure: Surgery; Radiation: Chest Irradiation; Drug: Cisplatin; Drug: Etoposide; Radiation: Prophylactic Cranial Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy
Locoregional control (LRC) defined as disease non-recurrence in a localized area for patients with resectable superior sulcus tumors treated with surgical resection followed by adjuvant chemoradiation. LRC measured as percentage of participants without recurrence at rates of local control as measured Years 2, 5, and 10.
Measured: Assessed from one month after completion of chemotherapy to year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startOct 1993
- Primary completionJun 2007
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ritsuko Komaki, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984997
- Sponsor's protocol ID
- ID92-038
- Status last verified
- Jun 2016
- First submitted
- 24 Sep 2009
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
- ClinicalTrials.gov ID
- NCT00984997
- Acronym / sponsor ID
- ID92-038
- Conditions
- Lung Cancer
- Keywords
- Superior Sulcus Tumor, Lung Cancer, Non-Small Cell, Multimodality Treatment, Surgery, Segmentectomy, Lobectomy, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 1993
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Sep 2009 (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.
- To determine the outcome of patients with potentially resectable superior sulcus tumors of non-small cell histology treated by surgery followed by accelerated radiation therapy and chemotherapy.
- To evaluate toxicity, the initial local-regional control rate, sites of and time to local and distant failures.
Detailed description
Eligible (surgically resectable and medically operable) patients will have surgery followed by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2 weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed by external radiotherapy.
Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10 days. The cycle will be repeated start day 29.
If the patients are considered to have no evidence of disease in one month after completion of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions once daily for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery + Radiotherapy + Chemotherapy | Experimental | Procedure: Surgery, Radiation: Chest Irradiation, Drug: Cisplatin, Drug: Etoposide, Radiation: Prophylactic Cranial IrradiationSurgery followed by radiotherapy and chemotherapy started at the beginning of radiotherapy. Segmentectomy or lobectomy with en bloc resection of the involved chest. Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week. Cisplatin 50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29. Etoposide given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29. Prophylactic Cranial Irradiation 25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No previous treatment.
- Tumor must be resectable.
- >/= 18 and </= 70 years of age.
- Zubrod performance status </= or higher performance status if based only on pain.
- Must have adequate bone marrow, liver and renal function as defined in 3.6.
Key exclusion criteria (3 listed)
- Cytological or histological proof of N3 disease.
- Evidence of metastatic disease to distant sites.
- Patients with impending cord compression will be ineligible.
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 |
|---|---|---|
| SurgerySegmentectomy or lobectomy with en bloc resection of the involved chest. | Procedure or surgery | Surgery + Radiotherapy + Chemotherapy |
| Chest IrradiationAlso: RadiotherapyRadiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week. | Radiation | Surgery + Radiotherapy + Chemotherapy |
| CisplatinAlso: Platinol, CDDP50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29. | Drug | Surgery + Radiotherapy + Chemotherapy |
| EtoposideAlso: VePesid, VP-16given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29. | Drug | Surgery + Radiotherapy + Chemotherapy |
| Prophylactic Cranial IrradiationAlso: PCI25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional. | Radiation | Surgery + Radiotherapy + Chemotherapy |
Primary outcome
Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy
Time frame: Assessed from one month after completion of chemotherapy to year 10
Locoregional control (LRC) defined as disease non-recurrence in a localized area for patients with resectable superior sulcus tumors treated with surgical resection followed by adjuvant chemoradiation. LRC measured as percentage of participants without recurrence at rates of local control as measured Years 2, 5, and 10.
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 30 Jun 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ritsuko Komaki, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery, Chest Irradiation and Cisplatin in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site 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?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Rates of Locoregional control (LRC) [Response] Following Surgery and Accelerated Radiation Therapy/Chemotherapy (time frame: Assessed from one month after completion of chemotherapy to year 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2016.