Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma
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| ClinicalTrials.gov Identifier: NCT01528618 |
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Recruitment Status :
Completed
First Posted : February 8, 2012
Last Update Posted : October 4, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nasopharyngeal Neoplasms | Drug: gemcitabine and cisplatin Drug: 5-Fluorouracil and cisplatin | Phase 3 |
Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China ,where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. NPC is a radiosensitive tumor, and radiotherapy is considered to be the treatment of choice for most cases. The 5-year survival rate (all stages) is around 50% .In other words, more than half of the NPC cases will eventually fail radiotherapy and reasons of the failure are both local relapse and remote metastasis.
For these advanced or metastatic NPC, chemotherapy is the most important therapeutics,and they are relatively responsive to chemotherapy compared to other head and neck cancers. The backbone of the treatment for recurrent/metastatic (R/M) NPC is cisplatin containing regimen, which is also regarded as the standard regimen for other squamous cell carcinoma of head and neck (SCCHN). The FP regimen is widely used in R/M NPC patients now and its response rate is around 40%-65%,but the response period is usually short and the adverse reaction is frequent and badly tolerant, which influent the treatment compliance seriously. What's more, the catheters and pumps are necessary for continuous infusion of 5-Fluorouracil, which add to the cost, immobility and inconvenience of the treatment.
Preclinical and clinical data show synergistic activity between gemcitabine and cisplatin without overlapping toxicity. Several clinical trials enrolling a minority of advanced NPC patients suggest GP regimen has promising effectiveness and well tolerated side effects, and they indicated a potential possibility that the GP regimen comes to the standard first line choice instead of the FP regimen
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 362 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) |
| Actual Study Start Date : | February 21, 2012 |
| Actual Primary Completion Date : | April 10, 2016 |
| Actual Study Completion Date : | December 20, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: gemcitabine and cisplatin
gemcitabine 1,000 mg/m2 over 30 to 60 minutes on days 1, 8, and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
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Drug: gemcitabine and cisplatin
The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1 only
Other Name: GP |
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Active Comparator: 5-Fluorouracil and cisplatin
5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
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Drug: 5-Fluorouracil and cisplatin
The FP regimen consists of 5-Fluorouracil 1,000 mg/m2/day which was administered as a continuous intravenous infusion for 96 hours after completion of the cisplatin on days 1( 80 mg/m2 i.v. infusion for 4 h)
Other Name: FP |
- Progression free survival (PFS) assessed by independent image committee and the investigators [ Time Frame: 36 months ]
- Overall survival (OS) [ Time Frame: 36 months ]
- Objective response rate (ORR) [ Time Frame: 36 months ]
- Number of Participants with Adverse Events [ Time Frame: 36 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven NPC diagnosis
- Elder than 18 years old are inclusive
- Recurrence or metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment
- Amenable to regular follow-up
- Subjects with at least one measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable).
- 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)
- No chemotherapy or radical radiotherapy received within 6 months prior to enrollment
- Life expectancy over twelve weeks
- Signed and dated informed consent before the start of specific protocol procedures
- Ability to comply with trial requirements.
Exclusion Criteria:
- Patient suitable for local treatment (eg. radiotherapy)
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- Patient with central nervous system metastasis
- Patient life threatening medical condition
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
- Performance status ≥ 2
- With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTC] grade ≥ 2)
- Serious concurrent illness
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors[Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- Patient refusing participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528618
| China, Guangdong | |
| Department of Medical Oncology,Cancer Center of Sun Yat-Sen University | |
| Guangzhou, Guangdong, China, 510060 | |
| Principal Investigator: | li zhang, doctor | Sun Yat-sen University |
| Responsible Party: | Li Zhang, MD, Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01528618 |
| Other Study ID Numbers: |
GEM20110714 |
| First Posted: | February 8, 2012 Key Record Dates |
| Last Update Posted: | October 4, 2021 |
| Last Verified: | September 2021 |
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Advanced Nasopharyngeal Carcinoma treatment |
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Carcinoma Nasopharyngeal Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases |
Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin Gemcitabine Fluorouracil Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |