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临床试验/NCT01373463
NCT01373463终止1 期

A Phase I Trial of Preoperative Carboplatin or Cisplatin and Pemetrexed With Thoracic Radiation Therapy Followed by Lobectomy in Resectable Stage III Patients With Non-Squamous Non Small Cell Lung Cancer (NSCLC)

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年5月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
48
试验地点
1
主要终点
Safety and tolerability
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.

The purpose of this study is to:

  • Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues.
  • Test the safety of different dose levels of radiation when given with each combination of chemotherapy;
  • Determine what side effects are associated with combining radiation with these two chemotherapy combinations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Histologically and cytologically confirmed non-squamous NSCLC.
  • •Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, T4N0-1
  • •Resectable T3 includes patients with a satellite lesion in the same lobe as the primary.
  • •Male or Female, aged > or = 18 years and be able to give informed consent.
  • •Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection.
  • •Patient should be medically operable
  • •ECOG Performance Status 0 or
  • •Adequate bone marrow, hepatic and renal function assessed within 28 days
  • •Signed informed consent.
  • •Women of childbearing potential should have negative pregnancy test prior to enrollment to study.
  • •Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter.
  • •The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
  • •The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  • •Patients must have a negative MRI or CT Scan of the brain.

排除标准

  • •Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • •Patients may not be receiving any other investigational agents.
  • •History of allergic reactions attributed to compounds or other agents used in study.
  • •Pregnant or lactating women.
  • •Male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
  • •Patients with concurrent serious infections.
  • •Patients with an unstable or serious concurrent medical condition are excluded.
  • •Presence of third space fluid which cannot be controlled by drainage.
  • •Weight loss > 10 percent from baseline weight.
  • •HIV-positive patients on combination antiretroviral therapy are ineligible
  • •Patients with hypercalcemia will be excluded.
  • •Patients who require a pneumonectomy will be excluded.

研究组 & 干预措施

Arm A

Experimental
  1. Patients will be given the drugs pemetrexed and carboplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Pemetrexed (Drug)

Arm A

Experimental
  1. Patients will be given the drugs pemetrexed and carboplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Carboplatin (Drug)

Arm A

Experimental
  1. Patients will be given the drugs pemetrexed and carboplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Radiation Therapy (Radiation)

Arm A

Experimental
  1. Patients will be given the drugs pemetrexed and carboplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Lobectomy (Procedure)

Arm B

Experimental
  1. Patients will be given the drugs pemetrexed and cisplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Pemetrexed (Drug)

Arm B

Experimental
  1. Patients will be given the drugs pemetrexed and cisplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Cisplatin (Drug)

Arm B

Experimental
  1. Patients will be given the drugs pemetrexed and cisplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Radiation Therapy (Radiation)

Arm B

Experimental
  1. Patients will be given the drugs pemetrexed and cisplatin
  2. Radiation
  3. Participants evaluated for response
  4. Lobectomy surgery

干预措施: Lobectomy (Procedure)

结局指标

主要结局

Safety and tolerability

Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.

次要结局

  • Response rate, overall survival and progression free survival

研究者

申办方类型
Other

研究点 (1)

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