Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer

• Sponsor: Loma Linda University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00614484
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 142
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Non-Small Cell Lung Cancer	Radiation: Proton Radiation Therapy; Drug: Taxol; Drug: Carboplatin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma
• Study Start Date: Aug 1, 1999
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Proton therapy with chemotherapy Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks. Proton therapy - 76 Gy in 5 weeks to lung tumor.

Radiation: Proton Radiation Therapy; A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.; Drug: Taxol; 200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.; Other Names: Paclitaxel ; Drug: Carboplatin; AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.

Outcome Measures

Primary Outcome Measures

1. Overall Survival. [Monthly for duration of participant lifespan. Average lifespan 1-2 years]

   Median survival time following treatment.

Secondary Outcome Measures

1. Treatment Related Toxicities. [Monthly for duration of participant lifespan. Average lifespan 1-2 years]

   grade 3 or higher esophageal toxicity Toxicity is categorized either early or late phase. Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical stage 2, 3A or 3B (unresectable)

• Histologic evidence of non-small cell carcinoma

• Age > 18 years

• Karnofsky performance status 70 or greater

• No prior radiation to the chest

• No previous chemotherapy

Exclusion Criteria:

• Clinical stage 1 or 4

• Previous malignancies except for non-melanoma skin cancer unless disease free for > 3 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: David A. Bush, MD, Loma Linda University Department of Radiation Medicine
• Study Chair: Jerry D. Slater, MD, Loma Linda University Department of Radiation Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT00614484
• Other Study ID Numbers: OSR #49168
• First Posted: Feb 13, 2008
• Last Update Posted: May 22, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Loma Linda University: Proton; Radiation
• Additional relevant MeSH terms: Lung Neoplasms; Paclitaxel; Carboplatin

Study Results

Participant Flow

Recruitment Details	Subject were recruited from the radiation oncology clinic from 11/99 through 4/11.

Arm/Group Title	Treatment With Chemotherapy and Proton Beam Radiotherapy.
Arm/Group Description	Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Period Title: Overall Study
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment With Chemotherapy and Proton Beam Radiotherapy.
Arm/Group Description	Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 46.4%
>=65 years	15 53.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (8)
Sex: Female, Male (Count of Participants)
Female	11 39.3%
Male	17 60.7%
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival.
Description	Median survival time following treatment.
Time Frame	Monthly for duration of participant lifespan. Average lifespan 1-2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemothrapy and Proton Therapy
Arm/Group Description	Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Measure Participants	28
Median (95% Confidence Interval) [Months]	15

2. Secondary Outcome

Title	Treatment Related Toxicities.
Description	grade 3 or higher esophageal toxicity Toxicity is categorized either early or late phase. Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter
Time Frame	Monthly for duration of participant lifespan. Average lifespan 1-2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemotherapy and Proton Therapy
Arm/Group Description	Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
Measure Participants	28
Number [participants]	2 7.1%

Adverse Events

Time Frame	Participants were followed for the duration of their lifespan, an average of 1-2 years
Arm/Group Title	Treatment With Chemotherapy and Proton Beam Radiotherapy.
Arm/Group Description	Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
All Cause Mortality
	Treatment With Chemotherapy and Proton Beam Radiotherapy.
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment With Chemotherapy and Proton Beam Radiotherapy.
	Affected / at Risk (%)	# Events
Total	4/28 (14.3%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis	2/28 (7.1%)	2
Pulmonary hemorrage	1/28 (3.6%)	1
Esophageal Fistula	1/28 (3.6%)	1
Other (Not Including Serious) Adverse Events
	Treatment With Chemotherapy and Proton Beam Radiotherapy.
	Affected / at Risk (%)	# Events
Total	12/28 (42.9%)
Respiratory, thoracic and mediastinal disorders
Esophagitis	12/28 (42.9%)	12

Limitations/Caveats

Slow enrollment over a long time period limits the conclusions that can be drawn.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.