MDACC Study Summary 2003-0424

Study Summary
No. 2003-0424:.......Cancer Prevention; Head And Neck; Lung......Waun Ki Hong......Thoracic and Head and Neck Med

Study Summary Title



Study Summary Number:	2003-0424

Study Title:	A Phase IIb Vanguard Study Characterizing the Occurrence of Recurrent or Second Primary Tumors in Patients with a Prior History of a Definitively Treated Stage I/II Head and Neck or Non-Small Cell Lung Cancer who are Current or Former Smokers

Physician

New Patient Referral



Name:	Waun Ki Hong	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic and Head and Neck Med	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention Head And Neck Lung	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Participants will return to the clinic every 6 months.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help predict the likelihood of lung cancer occurrence in this population. This will be done by studying characteristics of tissue and bodily fluids (including blood).

Study Objectives / Outcomes

To assess the smoking-related disease-free survival in patients who are current or former smokers with a prior definitively-treated stage I/II lung or head and neck cancer.

To develop a risk model to help predict the likelihood of lung cancer development both imaging and biomarker based in this high-risk population.

Study Status Information



Study Activation / Registration Date:	08/25/2004

IRB Review and Approval Date:	01/21/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	63 enrolled; 50 evaluable

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) Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).

2) HNSCC patients:Definitive local treatment </= 12 months prior to trial enrollment. NSCLC patients: Surgery </= 12 months prior to trial enrollment.

3) No evidence residual cancer

4) Age > = 18 years

5) Performance status of 0- 2 (Zubrod)

6) Patients must have no contraindications for undergoing bronchoscopy.

7) Patients must have no active pulmonary infections.

8) Participants must have the following blood levels: total granulocyte count >1500; platelet count > 100,000; total bilirubin < = 1.5 mg. %; and creatinine < = 1.5 mg %.

9) Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.

10) All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (b) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (c) side effects and health risks may occur, as described in the informed consent form.

11) Smoking history of at least 10 pack years. May be current or former smoker.

12) Subject must be considered legally capable of providing his or her own consent for participation in this study.

13) HNSCC patients only: Must have no contraindications for undergoing laryngoscopy.

Exclusion Criteria:

1) History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.

2) History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.

3) Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required).

4) Participants with active pulmonary infections or recent history of pulmonary infection (within one month).

5) Participants with acute intercurrent illness.

6) Participants requiring chronic ongoing treatment with NSAIDs except aspirin.

7) Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris.

8) Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.

9) Patients may not take high dose synthetic or natural Vitamin A derivatives (> 10,000 IU per day). "High dose" is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician.

10) History of biologic therapy.

Links

Registration Number: NCT00352391
Study Information on Clinical Trials Registry (clinicaltrials.gov)