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The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Advanced Primary Lung Adenocarcinoma

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Trial Information

The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar


Inclusion Criteria:



- Histologically or cytologically newly diagnosed as unresectable and metastasis
advanced lung adenocarcinoma(Stage IV, Seventh Edition of the UICC/AJCC
Classification for Lung Cancer).

- At least one measurable objective tumor lesion, spiral CT or PET-CT examination: the
shortest diameter ≥2cm,and no obvious necrosis

- Life expectancy ≥12weeks

- Patients receive palliative radiotherapy for bone's pain relief; patients receive
radiotherapy for brain metastasis、patients after brain transfer operation or
radiation therapy are allowed to enter the research.

- 18≤Patients'age <70 years.

- Electrocolonogram (ECOG) Score:0-1.

- Granulocyte count ≥ 2.0×109/L, platelet count ≥ 100×109/L.

- Serum bilirubin within the normal range.

- Aspartate aminotransferase ( AST ), Alanine aminotransferase ( ALT ) within the
normal range(if the patients is diagonosed as liver metastasis,his/her AST/ALT should
not surpass 1.5 times of the normal range ).

- Serum creatinine within the normal range and creatinine clearance rate ≥60ml/min

- Compliance with research requirements and be able to follow up.

- Within 72 hours before the treatment, all women pregnant with pregnant possibility
should undergo pregnancy test and get negative results.

- Patients with fertility ability should take effective contraceptive techniques.

- Sign informed consent of this clinic trial.

Exclusion Criteria:

- Lung adenocarcinoma patients who received systemic chemotherapy/thoracic
radiotherapy/targeted therapy

- Received resection, cutting or aspiration within seven days

- Any unstable systemic diseases (including peptic ulcer、active infection、grade4
hypertension、unstable angina、congestive heart failure、liver, metabolic disorders or
fracture、unhealing wound )

- Chronic kidney disease history(including chronic nephritis, nephrotic syndrome,
Obstruction of urinary tract etc. caused by Urinary calculus)

- have to use anticoagulant drugs at the same time

- patients with obvious coagulation disorders、active bleeding and bleeding tendency

- Any other malignancies (complete cure of cervical carcinoma in situ/basal cell
carcinoma/squamous cell carcinoma are excluded )happened within 5 years.

- Signifinant weight loss, weight lost during the 6 weeks more than or equal to 10%

- Patients who take bone metastasis as the only observing index

- Allergic to escherichia coli preparation

- Used Endostar before

- Lactating women

- Contraindications written on Pemetrexed、Carboplatin、Dexamethasone instructions

- Allergic to radiographic contrast agents

- In the middle or planning to attend other clinic trails

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

the change of blood perfusion before/after the use of Endostar

Outcome Time Frame:

per 3 weeks

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

sim-endo-201201

NCT ID:

NCT01564329

Start Date:

March 2012

Completion Date:

July 2013

Related Keywords:

  • Advanced Primary Lung Adenocarcinoma
  • endostar
  • CT Perfusion
  • Advanced Primary Lung Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms

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