Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: Chemoradiotherapy Regimen between PC and PE

Study type: Interventional

Funder types: Other

Identifiers

NCT01494558

2006BAI02A02[1]-03

Details and patient eligibility

About

Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. The second purpose is to evaluate quality of life and cost.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Inoperable stage IIIA/IIIB NSCLC proved by pathology or cytology
2. Age 18 to 75, ECOG ≤ 2, lose weight <10% during 6 months
3. No serious diseases of important organs
4. Chest CT in recently 4 weeks
5. No other tumor disease except stage I cervical cancer or cutaneous basal cell carcinoma
6. Sign consent
7. Measurable lesion

Exclusion criteria

1. Pretreatment radiotherapy or chemotherapy
2. Pregnant or lactation woman
3. Serious diseases (include uncontrolled diabetes and infection) of important organs
4. Psychopath
5. Join in other clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

PE concurrent chemotherapy

Active Comparator group

Description:

Radiotherapy concurrently with PE chemotherapy

Treatment:

Other: Chemoradiotherapy Regimen between PC and PE

PC concurrent chemotherapy

Active Comparator group

Description:

Radiotherapy concurrently with PC chemotherapy

Treatment:

Other: Chemoradiotherapy Regimen between PC and PE