Pemetrexed and Platinum Use in the Neoadjuvant Setting for Resectable Stage II and IIIA Lung Adenocarcinoma (ECTOP-1002)

NCT02980991 | Completed Phase 2

• 1 other identifier: PCPOII
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1002. The study is a prospective, single-center, open-label, single-armed, phase II clinical trial. The aim of the study is to evaluate the radiological response rate (RR) of 2 cycles of neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable stage II and IIIA lung adenocarcinoma.

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• radiological response rate

  Three to four weeks after the first cycle of neoadjuvant chemotherapy, the same radiological examination as baseline chest CT or PET/CT scans are repeated for tumor response evaluation. Radiographic response was recorded by RECIST 1.1.

  Three to four weeks after the second cycle of neoadjuvant chemotherapy

Secondary Outcomes (1)

• Number of Adverse Events of chemotherapy

  ten months after neoadjuvant chemotherapy

Study Arms (1)

Neoadjuvant chemotherapy group

EXPERIMENTAL

Two cycles of pemetrexed and cisplatin given to patients before surgery

Drug: Pemetrexed; Drug: Cisplatin

Interventions

Pemetrexed DRUG

Two cycles of pemetrexed 500mg/m2 day 1, 21 days per cycle for patients before surgery

Also known as: Neoadjuvant chemotherapy

Neoadjuvant chemotherapy group

Cisplatin DRUG

Two cycles of cisplatin 75mg/m2 day 1 (or 25mg/m2 day 1-3), 21 days per cycle for patients before surgery

Also known as: Neoadjuvant chemotherapy

Neoadjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent must be signed.
• At least 18 years of age.
• Histologically or cytologically diagnosed as lung adenocarcinoma.
• Have measurable and clinical stage II-IIIA (excluding superior sulcus) disease eligible for surgery.
• No previous systematic therapy or radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have a predicted postresection forced expiratory volume in 1 second (FEV1) of ≧1.0 L.
• Have adequate organ function including the following:
• Bone marrow: absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥100\*109/L, hemoglobin ≥8 g/dL.
• Hepatic: bilirubin ≤1.5 ULN, alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) ≤3.0 ULN.
• Renal: calculated creatinine clearance ≥45 mL/min (using the standard Cockcroft-Gault formula).
• For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have negative serum or urine pregnancy test and must not be lactating. For men: must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period.

You may not qualify if:

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry or concurrent administration of any other anti-tumor therapy.
• Clinically diagnosed as stage I or IIIB.
• Have history of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors \[Ta, Tis \& T1\].
• Concurrent use of any other anti-cancer therapy during study treatment.
• Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
• Significant cardiovascular event: congestive heart failure \> New York Heart Association (NYHA) class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g. naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
• Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
• Inability to comply with protocol or study procedures.
• Pregnant or breast-feeding women and childbearing potential women with either a positive or no pregnancy test within 48 hours of the start of treatment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Pemetrexed; Neoadjuvant Therapy; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Combined Modality Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Haiquan Chen, M.D, PH.D

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Thoracic Surgery, Shanghai Cancer Center

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 2, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)