MDACC Study Summary 2004-0977

Study Summary
No. 2004-0977:.......Lung......Joe Y. Chang......Radiation Oncology

Study Summary Title



Study Summary Number:	2004-0977

Study Title:	Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) 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:	.

Treatment Agents:	Proton Therapy	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can help to control NSCLC. The safety of this treatment will also be studied.

Study Objectives / Outcomes

To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with inoperable centrally/superiorly located stage Ia (T1, N0, M0), any stage Ib (T2, N0M0) and selected stage II (T3N0M0) non-small cell lung cancer (NSCLC).

Primary goals:
1. Improve the 2 year local control rate at the primary site over historical results
2. Reduce acute and chronic toxicity (according to the NCI Common Terminology Criteria for Adverse Events version 3.0 [CTCAE v3.0]

Secondary goals:
1. Improve the disease specific survival rate at 2 years over historical results.
2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.
3. Study the role of biomarkers in predicting therapeutic response and toxicities.

Study Status Information



Study Activation / Registration Date:	05/04/2006

IRB Review and Approval Date:	03/21/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	40

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) Patients with inoperable centrally/superiorly located tumors, defined as those (with any tumor edge measured within 30 days by the CT image using lung window level including simulation CT or MRI or PET/CT) located within 2 cm of the bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi);

3) Cont. from 2: major vessels (aorta, pulmonary artery trunk, left/right pulmonary artery/vein main branches, superior/inferior vena cava, brachiocephalic artery trunk or left/right brachiocephalic vein, left/right subclavian artery/vein), esophagus, heart, tracheal, pericardium, mediastinal pleural and brachial plexus and vetebral body, but no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0 (selected stage II with chest wall involvement) NSCLC.

4) Performance score KPS 60-100.

5) Negative pregnancy test for women of child bearing potential.

Exclusion Criteria:

1) Prior radiotherapy to the chest.

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 2 years for cure with life expectance more than 5 years .

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

Links

Registration Number: NCT00495040
Study Information on Clinical Trials Registry (clinicaltrials.gov)