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Status unknownNCT00846443Updated Feb 18, 2009

Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer

A Phase 1 interventional study of Concurrent Pemetrexed, Cisplatin and Radiotherapy and Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-18.

Sponsored by Fudan University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the recommended dose of pemetrexed and the maximum tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the patients with local advanced non-small cell lung cancer.

Read the detailed description

This study was conducted to explore the feasibility of concurrent chemoradiation therapy with pemetrexed, cisplatin and radiotherapy in unresectable local advanced non-small cell lung cancer. We will perform the dose escalation of pemetrexed to determine if full dose (500mg/m2) of pemetrexed could be administrated concurrently with cisplatin and conventional dose radiotherapy (66Gy) firstly. Secondly, radiation dose will be escalated to determine the maximum tolerated dose (MTD) of radiotherapy when administered concurrently with full dose pemetrexed and cisplatin.

02

Conditions studied

  • Local Advanced Non-Small Cell Lung Cancer

Keywords

  • non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 12 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≧18 years.
  • Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Patients with histologically or cytological-proven non-small cell lung cancer.
  • Stage IIIA or IIIB, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
  • Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
  • Weight loss ≦ 5% in the previous six months.
  • Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion criteria

Exclusion Criteria:

  • Undifferentiated small cell carcinoma, any stage.
  • Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  • Stage IV.
  • Age \<18 years.
  • Performance status ≧2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Previous chemotherapy or previous biologic response modifiers for current lung cancer.
  • Patient has previously had thoracic radiation therapy.
  • 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.
  • Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
  • 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.
  • History of significant neurological or mental disorder, including seizures or dementia.
  • 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.
  • Pregnant or lactating females.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    1

    pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions

    Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy

  • Experimental
    2

    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions

    Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy

  • Experimental
    3

    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions

    Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy

  • Experimental
    4

    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions

    Other: Concurrent Pemetrexed, Cisplatin and Radiotherapy

Interventions

  • OtherConcurrent Pemetrexed, Cisplatin and Radiotherapy

    pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions

  • OtherConcurrent Pemetrexed, Cisplatin and Radiotherapy

    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions

  • OtherConcurrent Pemetrexed, Cisplatin and Radiotherapy

    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions

  • OtherConcurrent Pemetrexed, Cisplatin and Radiotherapy

    pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicities per protocol

    Time frame: every 3 months from the end of treatment to 2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Radiation Oncolory, Cancer Hospital, Fudan University
    Shanghai, Shanghai 200032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00846443
Lead sponsor
Fudan University
First posted
Feb 18, 2009
Start date
Jan 2009
Primary completion
Jan 2010 (estimated)
Last update
Feb 18, 2009

Study contacts

Xiaolong Fu, MD
Contact
xlfu1964@126.com
862164175590 ext. 1408
Zhengfei Zhu, MD
Contact
zfeizhu@yahoo.com.cn
862164175590 ext. 1404

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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