|
| RTOG 0123 |
|---|
| Title: |
A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy +/- Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, Or Limited-Stage Small-Cell Lung Cancer |
| Eligibility: |
Stage II-IIIB non-small cell lung cancer or Stage I central NSCLC (excluding peripheral coin lesions) or limited-stage small-cell lung cancer (nonmetastatic disease that is receiving radiotherapy, and the target is confined to a single radiation treatment area); Patients must be > 18 years of age; Zubrod Performance Status of 0-1; Planned total dose of 45 Gy delivered to the target volume and > 25% of lung receiving > 20 Gy, if receiving radiotherapy alone; 3D planning CT to measure lung volume irradiated; Surgery < pneumonectomy (i.e. lobectomy or segmentectomy); Induction or concomitant chemotherapy allowed (either during radiotherapy or during therapy with captopril); Blood pressure: Systolic > 110, Diastolic > 60; absolute granulocyte count > 1,000/mm3; platelets > 75,000/mm3; Hg > 9.0 g/dl; BUN < 25 mg/dl; serum creatinine < 1.6/dl; serum bilirubin < 1.5 mg/dl; SGOT < 2X normal; Serum Na+ and serum K + within institutional normal; urine protein < 10 mg/dl; urine glucose negative; negative serum pregnancy test for women of childbearing potential; No requirement for ACE inhibitor for hypertension or congestive heart failure; No collagen vascular disease, i.e., lupus and scleroderma; patients with rheumatoid arthritis are eligible; No known hypersensitivity to ACE inhibitors; Not on lithium, methotrexate, or procainamide medication; No current pregnancy as radiation and captopril are contraindicated in pregnancy; Signed study-specific informed consent prior to registration.
|
| Observation Vs. Captopril |
- Register within 7 days prior to start of radiation therapy or during radiation therapy up to 48 hours prior to observation or captopril.
- Pre-randomization evaluations within 2 weeks prior to randomization.
- Randomization within 48 hours prior to start of observation or captopril
|
| Study Size: | 205 |
| RTOG L-0127 (ECOG E5597 - Coordinating Group) |
|---|
| Title: |
Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage I Non-Small Cell Lung Cancer |
| Eligibility: |
Patients who have undergone complete resection of a histologically proven stage 1A (pT1N0) or stage 1B
(pT2N0) non-small cell lung cancer (except carcinoid) who are currently free of disease. To be pathologic stage N0, at least one mediastinal lymph node must have been sampled at resection.;
NOTE: CALGB and SWOG patients must be stage T1N0 to be eligible for this study;
CALGB patients who are stage T2N0 are eligible only if they have undergone complete resection prior to June 1, 2001 and have previously refused participation in CALGB 9633 if offered.;
Eligible patients are those between 6 months and 36 months from date of surgical resection. Pathology material from the initial diagnosis must be available for review if recurrence occurs.;
Patients must not have received or be currently receiving chemotherapy or radiotherapy for lung cancer. Chest x-ray or Chest CT < 8 weeks prior to randomization must show no sign of new or recurrent lung cancer.;
Patients must be > 18 years of age.;
Patients must have normal hepatic function (total bilirubin and SGOT (AST) or SGPT (ALT), defined as less than or equal to the institutional upper limit of normal. These laboratory values must be obtained within 8 weeks prior to registration.;
Patients must have an ECOG performance status of 0-1.;
Patients not taking mineral, herbal, phytochemical, or vitamin supplements at the time of entry must agree to not begin taking such supplements (except for the study designated tablet) during the course of participation. Patients taking any supplement(s) prior to study entry must agree to one of the following in order to be eligible:
NOTE: Supplements are defined as any non-food compound taken by mouth or injection which are intended to provide dietary factors.;
Patients who have been regularly (at least 3 times per week for more than 4 consecutive weeks during the year prior to consideration for the trial) taking a supplement containing selenium are not eligible if the supplement contains > 50 µg selenium.;
Patiens who have been regularly (at least 3 times per week for more than 4 consecutive weeks during the year prior to consideration for the trial) taking a supplement that contains < 50 µg selenium are eligible, provided (s)he agrees to continue taking the same supplement on the same schedule for the entire duration of study participation.;
If the supplement does NOT contain selenium, the patient must discontinue supplement(s) for at least two weeks prior to study entry and agree to remain off supplement(s) for the duration of study participation; OR agree to continue taking the same supplement(s), on the same schedule for the entire duration of study participation.;
Any supplement(s) containing > 50 µg of selenium are absolutely disallowed in this study.;
No concurrent cancers or any prior cancer history within the past 5 years except localized non-melanoma skin cancer.;
No synchronous lesions (lung + non-lung) or metastasis, even if resectable. No history of greater than one lung cancer primary at any time.;
Patients must be free of disease.;
Patients must have consumed at least 75% of tablets during 4 week run-in period. |
| TX: | Selenium yeast vs. placebo yeast. |
| Sample Size: | 1750 |
| RTOG 0229 |
|---|
| Number: |
RTOG 0229 |
| Title: |
A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma |
| Eligibility: |
Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present); Disease must be measurable; Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease; Patients > 18 years of age; Life expectancy > 6 months;Zubrod performance status 0- 1 (See Appendix II);Pretreatment laboratory values must be as follows: WBC count: >3,000/mm3; Absolute granulocyte count: > 1,500/mm3; Platelets: > 100,000/mm3; Total bilirubin: < 1.5 x institutional ULN; Serum creatinine: < 1.5 x institutional ULN; AST and ALT: < 2.5 x institutional ULN; serum albumin: > 3.0 g/dL; Baseline FEV1 > 2 liters (if < 2 liters, V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative V/Q scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report); Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy; Women of childbearing potential and male participants must practice an effective method of contraception during the study; Patients must sign a study-specific informed consent (Appendix I) prior to study entry.
|
| Induction Chemoradiation; Surgery; Consolidation Chemotherapy |
Induction Chemoradiation:
Paclitaxel and Carboplatin 1x/week for 6 weeks (See Section 7.0 for details) plus
Concurrent RT: 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions (See Section 6.1 for details) plus
RT Boost: 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions (See Section 6.1 for details)
Reassessment: 4 weeks post Induction Chemoradiation;Resection
Consolidation Chemotherapy: Paclitaxel and Carboplatin q 21 days x 2
|
| Study size: | 60 |
| RTOG 0617 |
|---|
| Title: |
A Randomized Phase III Comparison Of Standard- Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer |
| Eligibility: |
Patients must have a pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer.
Patients must be considered unresectable or inoperable. Patients must have measurable or evaluable disease.
Patients with post-obstructive pneumonia are eligible. Patients must be at least 3 weeks from prior thoracotomy (if performed).
Patients also must meet the following parameters:
- Zubrod Performance Status 0-1;
- Age > 18;
- FEV1: best value obtained pre- or post bronchodilator must be > 1.5 liters/second;
- Adequate bone marrow function as defined in the protocol;
- Serum creatinine < 1.5 x IULN or creatinine clearance >40 ml/min;
- Bilirubin < 1.5 x IULN;
- AST and ALT < 2.5 x the IULN.
Patients with N3 supraclavicular disease are excluded.
No greater than minimal, exudative, or cytologically positive pleural effusions.
No pancoast tumors. No involved contralateral hilar nodes. Patients with >
10% weight loss within the past month are ineligible. No prior invasive malignancy
(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
No prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different
cancer is allowable. No prior radiotherapy to the region of the study cancer that would result in
overlap of radiation therapy fields. No severe, active co-morbidity as defined in the protocol.
Patients with any history of allergic reaction to paclitaxel or other taxanes or to carboplatin are not
eligible. No uncontrolled neuropathy > grade 2 regardless of cause. Pregnant women or women of
childbearing potential and men who are sexually active and not willing/able to use medically acceptable
forms of contraception are excluded because the treatment
involved in this study may be significantly teratogenic.
|
| Standard Dose (60 Gy) versus High Dose
(74 Gy) Conformal Radiotherapy With
Concurrent and Consolidation Chemotherapy. |
Arm A:
Concurrent Carboplatin/Paclitaxel, Weekly x 7
RT to 60 Gy, 5 x per week for 6 weeks
Arm B:
Concurrent Carboplatin/Paclitaxel, Weekly x 7
RT to 74 Gy, 5 x per week for 7.5 weeks
All patients:
Consolidation Carboplatin/Paclitaxel, Q 3 weeks x 2 cycles
|
| Sample Size: | 512 |
| RTOG 0618 |
|---|
| Title: |
A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer |
| Eligibility: |
Histological confirmation of NSCLC is required by either biopsy or cytology within 60 days prior to registration. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise specified. Although bronchioloalveolar cell carcinoma is a subtype of NSCLC, patients with the pure type of this malignancy are excluded from this protocol because this cancer's spread between adjacent airways is difficult to target on CT. Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC Lung 6th Edition, 2002 stage I or II based on only one of the following combinations of TNM staging:
- T1, N0, M0
- T2 ( 5 cm), N0, M0
- T3 ( 5 cm), N0, M0 chest wall primary tumors only
The patient must be considered a reasonable candidate for surgical resection of the primary tumor according to the following criteria:
- A qualified thoracic surgeon should make the determination prior to registration that there would be a high likelihood of negative surgical margins.
- baseline FEV1 > 40% predicted,
- postoperative predicted FEV1 > 30% predicted,
- diffusion capacity > 40% predicted,
- absent baseline hypoxemia and/or hypercapnia,
- exercise oxygen consumption > 50% predicted,
- absent severe pulmonary hypertension,
- absent severe cerebral, cardiac, or peripheral vascular disease,
- absent severe chronic heart disease.
Pulmonary function: FEV1, best value obtained pre- or post bronchodilator, must be > 1.5 liters/second; Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray. Pleural effusion that appears on chest x-ray will be permitted only after thoracotomy or other invasive procedure; Age > 18 years; Zubrod performance status 0-1within 45 days prior to study entry; Women of childbearing potential and male participants must use an effective contraceptive method, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills. CBC/differential obtained within 28 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) > 1,800 cells/mm3, Platelets > 100,000 cells/mm3, Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.) Patient must provide study-specific consent prior to study entry.
|
| Treatment |
Stereotactic Body Radiation Therapy (SBRT), 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy |
| Sample Size: | 33 |
| RTOG 0623 |
|---|
| Title: |
A Phase II Trial Of Combined Modality Therapy With Growth Factor Support For Patients With Limited Stage Small Cell Lung Cancer |
| Eligibility: |
Pathologically (histologically or cytologically) proven diagnosis of small cell carcinoma of the lung; Patients must have limited disease, i.e., confined to one hemithorax, but excluding T4 tumor based on malignant pleural effusion or N3 disease based on contralateral supraclavicular involvement; Patients must have measurable or evaluable disease, and location, type, and size of all measurable lesions present prior to treatment must be recorded; Limited SCLC, including no distant metastases, based upon the diagnostic workup specified in the protocol; Zubrod Performance Status 0-1(Appendix III); Age > 18; Adequate bone marrow, hepatic, and renal function as specified in the protocol; FEV1: best value obtained pre- or post bronchodilator must be > 1.5 liters/second; A Radiation Oncologist must certify that the tumor can be encompassed by limited radiotherapy fields without significantly compromising pulmonary function; Pleural effusion, if present, must be deemed too small to tap under CT guidance and must not be evident on chest x-ray; Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment); Patient must provide study specific informed consent prior to study entry. |
Radiation Therapy, Concurrent Chemotherapy, and Filgrastim
Adjuvant Chemotherapy and Pegfilgrastim
|
Radiation Therapy: Total of 61.2 Gy in 5 weeks
Day 1: Cisplatin, 60 mg/m2; Days 1-3: Etoposide, 120 mg/m2
Repeat cycle every 3 weeks x 2 cycles
Filgrastim: Days 4-13 and 25-34
Cycles 1 & 2:
Day 43 & 64: Cisplatin, 60 mg/m2 and
Etoposide, 120 mg/m2
Days 44-45 & 65-66: Etoposide, 120 mg/m2
Pegfilgrastim: Day 4 of each adjuvant cycle
|
| Sample Size: | 44 |
|
|
|
|
