Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Docetaxel

Carboplatin

Radiation therapy

Surgical resection

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed stage IIIA or IIIB NSCLC Patients must have measurable disease No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC. Age>18 years Life expectancy >12 months ECOG performance status 0-1 Normal organ and marrow function Medically fit for surgery at time of enrollment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment. Ability to understand and willingness to sign the consent form. Exclusion Criteria: Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC. Patients receiving any other investigational agents. Known metastatic disease (brain or any other site) History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study. Peripheral neuropathy >grade 1 Uncontrolled concurrent illness Pregnant women Weight loss>10% in the past 3 months before diagnosis. Hyperglycemia - exclusion from PET analysis HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy+Radiation+Surgery

Arm Description

Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.

Outcomes

Primary Outcome Measures

2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.

Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.

Secondary Outcome Measures

Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival

The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.

Full Information

NCT ID

NCT00238615

First Posted

October 11, 2005

Last Updated

April 21, 2015

Sponsor

Stanford University

Collaborators

Aventis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00238615

Brief Title

Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

Official Title

A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

March 2003 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy+Radiation+Surgery

Arm Type

Experimental

Arm Description

Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

20 mg/m2, 75 mg/m2 infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

AUC of 2 and 6 infusion

Intervention Type

Procedure

Intervention Name(s)

Radiation therapy

Other Intervention Name(s)

radiation oncology, radiotherapy

Intervention Description

NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.

Intervention Type

Procedure

Intervention Name(s)

Surgical resection

Other Intervention Name(s)

segmentectomy, segmental resection

Intervention Description

All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.

Primary Outcome Measure Information:

Title

2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.

Description

Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.

Time Frame

Two years

Secondary Outcome Measure Information:

Title

Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival

Description

The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.

Time Frame

baseline, 5 weeks after combined chemo-radiation

Other Pre-specified Outcome Measures:

Title

Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen

Description

This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.

Time Frame

Specimen collected at time of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologically confirmed stage IIIA or IIIB NSCLC Patients must have measurable disease No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC. Age>18 years Life expectancy >12 months ECOG performance status 0-1 Normal organ and marrow function Medically fit for surgery at time of enrollment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment. Ability to understand and willingness to sign the consent form. Exclusion Criteria: Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC. Patients receiving any other investigational agents. Known metastatic disease (brain or any other site) History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study. Peripheral neuropathy >grade 1 Uncontrolled concurrent illness Pregnant women Weight loss>10% in the past 3 months before diagnosis. Hyperglycemia - exclusion from PET analysis HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather A. Wakelee

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21774104

Citation

Kozak MM, Murphy JD, Schipper ML, Donington JS, Zhou L, Whyte RI, Shrager JB, Hoang CD, Bazan J, Maxim PG, Graves EE, Diehn M, Hara WY, Quon A, Le QT, Wakelee HA, Loo BW Jr. Tumor volume as a potential imaging-based risk-stratification factor in trimodality therapy for locally advanced non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):920-6. doi: 10.1097/jto.0b013e31821517db.

Results Reference

result

PubMed Identifier

21752720

Citation

Das M, Donington JS, Murphy J, Kozak M, Eclov N, Whyte RI, Hoang CD, Zhou L, Le QT, Loo BW, Wakelee H. Results from a single institution phase II trial of concurrent docetaxel/carboplatin/radiotherapy followed by surgical resection and consolidation docetaxel/carboplatin in stage III non-small-cell lung cancer. Clin Lung Cancer. 2011 Sep;12(5):280-5. doi: 10.1016/j.cllc.2011.06.003. Epub 2011 Jul 14.

Results Reference

result

Lung Cancer, Carcinoma, Non-Small-Cell Lung

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial