Methylprednisolone After Split-course Chemoradiotherapy For Bulky Local Advanced None-small Cell Lung Cancer

Sun Yat-sen University

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: concurrent chemotherapy; Drug: Methylprednisolone; Radiation: chest radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03661567

GASTO-1044

Details and patient eligibility

About

This Phase II randomized controlled study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy (CCRT) in locally advanced non-small cell lung cancer with bulky tumor.

Full description

This study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer with bulky tumor.

All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break. In the experimental arm, patients were treated with methylprednisolone after the first course of radiation, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days,then 16mg for 7 days, and 8 mg for the last 7 days. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologic confirmation of NSCLC.

• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

  • Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI.
  • Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Previously treated with chemotherapy or treatment-naive

• No previous chest radiotherapy, immunotherapy or biotherapy

• Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL

• Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min

• Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL

• FEV1 >0.8 L

• CB6 within normal limits

• patients and their family signed the informed consents

Exclusion criteria

• Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
• Contraindication for chemotherapy
• Malignant pleural or pericardial effusion.
• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
• Women who has the probability of pregnancy without contraception
• Tendency of hemorrhage
• In other clinical trials within 30 days
• Addicted in drugs or alcohol, AIDS patients
• Uncontrollable seizure or psychotic patients without self-control ability
• Severe allergy or idiosyncrasy
• Not suitable for this study judged by researchers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Methylprednisolone

Experimental group

Description:

Patients were treated with methylprednisolone after the first course of chest radiation and concurrent chemotherapy, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days.

Treatment:

Radiation: chest radiation

Drug: Methylprednisolone

Drug: concurrent chemotherapy

Observation

Active Comparator group

Description:

Observation after the first course of chest radiation, methylprednisolone can only be used for therapeutic purpose in the presence of grade≥2 radiation induced lung injury(NCI-CTC4.0).

Treatment:

Radiation: chest radiation

Drug: concurrent chemotherapy