MDACC Study Summary 2004-0976

Study Summary
No. 2004-0976:.......Lung......Joe Y. Chang......Radiation Oncology

Study Summary Title



Study Summary Number:	2004-0976

Study Title:	Phase II Concurrent proton and chemotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Physician

New Patient Referral



Name:	Joe Y. Chang	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Lung	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Follow up recommended 6 weeks after completion of radiotherapy, then required every 3 months (+ 1 month) x 2 year, then every 6 months (+ 1 month) x 3 years, then yearly. Long term toxicity for esophagus and lung is evaluated using CTC criteria.

Treatment Agents:	Carboplatin Proton Therapy Taxol	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to learn if proton radiotherapy given with standard chemotherapy (paclitaxel and carboplatin) can help to control locally advanced NSCLC. The safety of this treatment will also be studied.

Study Objectives / Outcomes

To assess therapeutic efficacy and toxicities of proton radiotherapy with concurrent chemotherapy for patients with inoperable stages IIIA/B non-small cell lung cancer (NSCLC).

Primary goal: Improve median survival.

Secondary goals:
1. Improve local control, progression free survival, disease specific survival and disease free survival.
2. Decrease grade 3 and above toxicities.
3. Pre- and post treatment PET/CT in predicting clinic outcome.
4. Biomarker for predicting treatment response and toxicities.

Study Status Information



Study Activation / Registration Date:	04/14/2006

IRB Review and Approval Date:	07/06/2005

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically or cytologically documented NSCLC.

2) Inoperable stage IIIA (T1--3N2MO, T3N1MO) and IIIB (T1-3N3MO, T4NO-3MO) disease excluding malignant pleural effusion.

3) Performance score KPS 70-100, Weight loss: less or equal to 10% in 6 months prior to diagnosis.

4) Patient consented for the protocol

5) Induction chemotherapy is allowed.

Exclusion Criteria:

1) Prior chest radiotherapy.

2) Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated more than 3 years ago for cure.

3) Pregnancy. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.

4) Off study criteria: a) If a patient is found to have distant metastasis during treatment and/or immediate after the treatment (<60 days) indicating inaccurate cancer stage, he or she will be taken off study. b) If a patient does not follow up at MD Anderson and does not forward his or her medical records such as CT, PET/CT, PFT or pathology report as required by protocol, he or she will be taken off study. c) If a patient does not have any required post-treatment evaluation such as images, he or she will be taken off study.

Links

Registration Number: NCT00495170
Study Information on Clinical Trials Registry (clinicaltrials.gov)