Squamous Cell Lung CancerPhase 2NCT02787473
A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer
A Phase 2 study testing pemetrexed, cisplatin and thoracic radiation therapy in people with Squamous Cell Lung Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Lung Cancer
- What is being tested?
- pemetrexed, cisplatin and thoracic radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer;
- All sites of disease must be amenable to definitive radiotherapy;
- Age 18 years to 75 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
- Forced expiratory volume in 1 second(FEV1)> 0.75L;
- No previous chest radiotherapy, immunotherapy or biotherapy;
Show all 10Show fewer
- Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
- For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
- Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;
- Patients and their family signed the informed consents;
Who cannot join
- Active infection;
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias);
- Malnutrition (loss of ≥ 20% of the original body weight);
- Performance status: 3-4;
- Sensor or motor neuropathy > grade I;
- Second primary malignancy, except for non-melanoma skin cancer;
- Psychiatric illness or social situation that would preclude study compliance;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Shirong Zhang, Dr., 086057156007650, shirley4444@gmail.com
About this study
Official title: A Phase II Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Docetaxel Consolidation in Patients With Inoperable Stage IIIA/B Squamous Cell Lung Cancer
To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.
- Conditions
- Squamous Cell Lung Cancer
- Being tested
- pemetrexed, cisplatin, thoracic radiation therapy, docetaxel
- Keywords
- Squamous cell lung cancer, Pemetrexed, Radiosensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
cisplatinDrug
Also called platinol
Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
thoracic radiation therapyRadiation
Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
docetaxelDrug
Also called taxotere
Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel | Experimental | Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78. Receives: Drug: pemetrexed; Drug: cisplatin; Radiation: thoracic radiation therapy; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: 3 years
Secondary outcomes (4)
Overall Survival
Measured: 3 years
Local control rate
Measured: 3 years
The short-term quality of life (QOL) assessed using FACT-E score
FACT-E score at the 4 months after docetaxel consolidation therapy
Measured: 4 months
Rate of CTCAE grade 2 or higher radiation pneumonitis
The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787473
- Sponsor's protocol ID
- HZCH-2016-10
- Status last verified
- Nov 2016
- First submitted
- 22 Apr 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Docetaxel Consolidation in Patients With Inoperable Stage IIIA/B Squamous Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02787473
- Acronym / sponsor ID
- HZCH-2016-10
- Conditions
- Squamous Cell Lung Cancer
- Keywords
- Squamous cell lung cancer, Pemetrexed, Radiosensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel | Experimental | Drug: pemetrexed, Drug: cisplatin, Radiation: thoracic radiation therapy, Drug: docetaxelPatients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer;
- All sites of disease must be amenable to definitive radiotherapy;
- Age 18 years to 75 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
- Forced expiratory volume in 1 second(FEV1)> 0.75L;
Key exclusion criteria (8 listed)
- Active infection;
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias);
- Malnutrition (loss of ≥ 20% of the original body weight);
- Performance status: 3-4;
- Sensor or motor neuropathy > grade I;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedPemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles | Drug | pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel |
| cisplatinAlso: platinolCisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles | Drug | pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel |
| thoracic radiation therapyChemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin | Radiation | pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel |
| docetaxelAlso: taxotereDocetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles | Drug | pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel |
Primary outcome
Overall Response Rate
Time frame: 3 years
4 secondary outcomes
Overall Survival
Time frame: 3 years
Local control rate
Time frame: 3 years
The short-term quality of life (QOL) assessed using FACT-E score
Time frame: 4 months
Rate of CTCAE grade 2 or higher radiation pneumonitis
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
Related trials for Squamous Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed, cisplatin and thoracic radiation therapy in people with Squamous Cell Lung Cancer, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenglin Ma, MD (0571-56007908 ext. 086, mashenglin@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.