MDACC Study Summary CALGB30610-RTOG0538

Study Summary
No. CALGB30610-RTOG0538:.......Lung......Ritsuko R. Komaki......Radiation Oncology

Study Summary Title



Study Summary Number:	CALGB30610-RTOG0538

Study Title:	Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide

Physician

New Patient Referral



Name:	Ritsuko R. Komaki	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:	Cancer and Leukemia Group B (CALGB)

Phase of Study:	Phase III	Return Visit:	Every 3 months for 2 years, every 6 months for 3 years, then at least every year for 5 years.

Treatment Agents:	Cisplatin Etoposide Radiation	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to compare the effectiveness and safety of 2 different ways to give radiation therapy (1 experimental, 1 standard) in combination with chemotherapy to patients with small-cell lung cancer. The safety of these therapies and their effects on your quality of life will also be studied.

Study Objectives / Outcomes

Primary Objective
To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3 weeks) in patients with limited stage small cell lung cancer.

Secondary Objectives

To compare treatment related toxic effects of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer.
To compare response rates, failure-free survival and toxicity of thoracic radiotherapy regimens in patients with limited stage small cell lung cancer.
To compare rates of local relapse, distant metastases and brain metastases with these regimens.
To compare patient's quality of life between these treatment regimens in terms of their physical symptoms, physical functioning and psychological state.
To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT) in patients with limited stage small cell lung cancer.
To examine blood-based biomarkers of response and resistance to cisplatin and etoposide.
To evaluate the correspondence between increases in plasma ProGRP concentrations and disease progression/recurrence.
To evaluate the potential for plasma ProGRP concentrations at baseline, after each cycle of chemotherapy and at first evaluation following completion of chemotherapy to predict PFS and OS.
To evaluate the correspondence between longitudinal decreases in plasma ProGRP concentrations and clinical response.

Study Status Information



Study Activation / Registration Date:	01/06/2009

IRB Review and Approval Date:	01/06/2009

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	729

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 small cell lung cancer.

2) Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases including ipsilateral hilar, ipsilateral and contralateral mediastinal and ipsilateral supraclavicular lymph nodes.

3) Patients must have measurable disease. *Measurable Disease- Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 2cm with conventional techniques or as >/= 1 cm with spiral CT scan.

4) Cont. from inclusion #3: Non measurable Disease- All other lesions, including small lesions (longest diameter < 20 mm with conventnional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions. a)Bone lesions b)Leptomeningeal disease c)Ascites d)Pleural/pericardial effusion e)Inflammatory breast disease f)Lymphangitis cutis/pulmonis g)Abdominal masses that are not confirmed and followed by imaging techniques h)Cystic lesions

5) Age >/= 18 years of age

6) ECOG Performance Status 0-2

7) Required Initial Laboratory Values: Granulocytes >/= 1,500/microL Platelet Count >/= 100,000/microL Total Bilirubin </= 1.5 x ULN AST (SGOT) </= 2.0 x ULN Serum Creatinine </= 1.5x ULN or Calculated Creatinine Clearance >/= 70 ml/min

Exclusion Criteria:

1) Prior Treatment: a) No prior radiotherapy or chemotherapy for SCLC b)No prior mediastinal or thoracic radiotherapy c)Patients with complete surgical resection of disease are not eligible

2) No patients that are known to be pregnant or nursing

3) Patients with disease involevement of the contralateral hilar or supraclavicular lymph nodes are not eligible.

4) Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible.

5) Patients with cytologically positive pleural or pericardial fluid, regrdless of the appearance on plain x-ray, are not eligible.

Links

Registration Number: NCT00632853
Study Information on Clinical Trials Registry (clinicaltrials.gov)