Comparison of Postoperative Adjuvant Chemotherapy With/Without Rh-endostatin on Non-small Cell Lung Cancer in PhaseⅠB
1 other identifier
interventional
392
1 country
1
Brief Summary
- Lung cancer is one of causes of the malignant tumor-associated death on a global scale, in which the surgery is the only effective approach in patients with non-small cell lung cancer (NSCLC). As present, the total postoperative 5-year survival rate of NSCLC is 40%, while only 4%～15% patients can benefit from adjuvant chemotherapy\[1\]. American National Comprehensive Cancer Network (NCCN) manual recommends that adjuvant chemotherapy can be performed on NSCLC patients in phase Ⅱ～ⅢA.
- In order to assure the necessity of adjuvant chemotherapy on NSCLC patients in phase ⅠB or which kind of patients would benefit from it after the establishment of new staging, a multi-subject group of lung cancer set up a perspective, randomized, open clinical trial to explore whether adjuvant chemotherapy was effective on NSCLC patients in phase ⅠB under new staging policy, and to collect the characteristics of patients who could benefit from the treatment and the better adjuvant drugs after operation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Oct 2013
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedDecember 4, 2013
November 1, 2013
7.2 years
November 4, 2013
November 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival
Disease free survival (DFS)is defined as the time during randomized inclusion to disease recurrence or death.
Patients will be followed up for 5 years
Secondary Outcomes (1)
Adverse reactions of adjuvant chemotherapy
Patients will be followed up for 5 years
Study Arms (4)
Pemetrexed &Cis-platinum
EXPERIMENTALPemetrexed d1＋Cis-platinum , d1, 21 d as a cycle.
Pemetrexed & Cis-platinum & rh-Endostatin
EXPERIMENTALPemetrexed d1＋Cis-platinum , d1； rh-Endostatin d1-14; 21 d as a cycle.
Docetaxel & Cis-platinum
EXPERIMENTALDocetaxel 60mg/m2 d1＋Cis-platinum 60mg/m2, d1, 21 d as a cycle.
Docetaxel & Cis-platinum & rh-Endostatin
EXPERIMENTALDocetaxel ＋ Cis-platinum ＋ rh-Endostatin，21 d as a cycle.
Interventions
Pemetrexed 500 mg/m2, d1, 21 d as a cycle.
Docetaxel 60mg/m2 d1＋Cis-platinum 60mg/m2, d1, 21 d as a cycle.
rh-Endostatin 7.5mg/m2 d1-14; 21 d as a cycle.
Cis-platinum 60mg/m2, d1, 21 d as a cycle.
Eligibility Criteria
You may qualify if:
- Patients who are diagnosed with NSCLC pathologically and T stage is T2a in postoperative pathological staging. No lymph node and distant metastasis are observed and the surgical methods include wedge incision, segmentectomy of right lung or lobe.
- Age: 18～70 years
- ECOG PS score: 0-1 score
- patients who are diagnosed with the high risk factors as follows: poor differentiation (including low differentiation, undifferentiation and neuro-endocrine differentiation), blood vessel invasion, wedge incision, tumor diameter \>4 cm, visceral pleura involvement, incomplete clear of lymph node and incisal edge \<1.0 cm.
- Patients who are diagnosed without tumor recurrence before adjuvant chemotherapy.
- Informed consent is signed.
You may not qualify if:
- Patients with unexpected pathological patterns or those have received new adjuvant chemotherapy.
- Patients with other active malignant tumor history beside NSCLC before treatment except non-melanoma skin cancer, primary cervical cancer and cured early prostate cancer.
- Patients who are with chemotherapeutic contraindications, such as white blood count \<4.0×109/L, blood platelet count \<80×109/L or severe anemia (Hb\<80 g/L); obvious liver dysfunction (increased transaminase or bilirubin \>2.5 folds of normal level); un-manageable hypertension, diabetes, arrhythmia, repeated heart failure and chronic obstructive pulmonary diseases that could influence ventilation function; active stage of diseases infected by bacteria, fungi and virus; or patients who are in pregnancy and lactation periods.
- Patients who are un-recovered and poor with chemotherapy after 8-week treatment, or have received above 8-week treatment before treatment.
- Patients who are in poor obedience or other improper symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pang Zuoliang, Postgraduate
Cancer Hospital of Xinjiang Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cancer Hospital Affiliated to Xinjiang Medical University
Study Record Dates
First Submitted
November 4, 2013
First Posted
December 4, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2020
Study Completion
October 1, 2022
Last Updated
December 4, 2013
Record last verified: 2013-11