GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China (NCT01596868) | Clinical Trial Compass
CompletedPhase 2
GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China
China60 participantsStarted 2012-05
Plain-language summary
The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC). The effectiveness, side effects and quality of life will be evaluated according to Standard WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H\&N35 questionnaire.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven WHO II\~III native NPC in northwest region of China;
* 18 Years to 70 Years;
* stages III-IVb according to AJCC stage classification(7th edition), no previous chemotherapy and radiotherapy;
* Performance status: 0-1(ECOG);
* WBC \> 4.0X109/L, PLT \> 100X109/L, with normal hepatic function(AST, ALT \< 2.5 x upper limit of normal, and bilirubin \< 1.5 x upper limit of normal), with normal renal function (Creatinine \< 1.5 x upper limit of normal);
* Ability to comply with trial requirements.
Exclusion Criteria:
* Evidence of metastases by clinical or radiographic examinations;
* History of malignancy;
* Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.;
* Patients with uncontrolled intercurrent disease;
* Patients with currently active malignancy;
* Pregnant or lactating women patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
overall response rate (ORR)
Timeframe: 3-year
Trial details
NCT IDNCT01596868
SponsorAir Force Military Medical University, China