Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
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| ClinicalTrials.gov Identifier: NCT03919552 |
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Recruitment Status :
Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
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Sponsor:
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
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Brief Summary:
The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cisplatin Carboplatin NPC | Drug: Docetaxel,Carboplatin Drug: Docetaxel,Cisplatin Radiation: Carboplatin-based concurrent chemoradiotherapy Radiation: Cisplatin-based concurrent chemoradiotherapy | Phase 3 |
Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 482 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma |
| Actual Study Start Date : | January 31, 2018 |
| Estimated Primary Completion Date : | January 31, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy.
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Drug: Docetaxel,Carboplatin
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
Other Name: TC induction chemotherapy Radiation: Carboplatin-based concurrent chemoradiotherapy Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent carboplatin |
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Active Comparator: Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy.
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Drug: Docetaxel,Cisplatin
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
Other Name: TP induction chemotherapy Radiation: Cisplatin-based concurrent chemoradiotherapy Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin |
Primary Outcome Measures :
- Failure-free survival [ Time Frame: 3-year ]Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Secondary Outcome Measures :
- Locoregional failure-free survival [ Time Frame: 3-year ]Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.
- Distant failure-free survival [ Time Frame: 3-year ]Distant failure-free survival is calculated from randomisation to the first locoregional failure.
- The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy. ]The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
- Toxic effects [ Time Frame: 3-year ]Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.
- Overall survival [ Time Frame: 3-year ]Overall survival is calculated from randomization to death from any cause.
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).
- No evidence of distant metastasis (M0).
- Satisfactory performance status: Karnofsky scale (KPS) > 70.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age ≥65 years or <18 years.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
Information from the National Library of Medicine
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): NCT03919552
Contacts
| Contact: Jian Guan, Ph.D. | +86-13632102247 | 51643930@qq.com |
Locations
| China, Guangdong | |
| Southern medical university | Recruiting |
| Guangzhou, Guangdong, China, 510515 | |
| Contact: Jian Guan, M.D. 86+13632102247 guanjian5461@163.com | |
| Principal Investigator: Jian Guan, M.D. | |
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
| Study Chair: | Jian Guan | Nanfang Hospital of Southern Medical University |
Publications:
| Responsible Party: | Nanfang Hospital of Southern Medical University |
| ClinicalTrials.gov Identifier: | NCT03919552 |
| Other Study ID Numbers: |
LC2016PY015 |
| First Posted: | April 18, 2019 Key Record Dates |
| Last Update Posted: | April 18, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Nanfang Hospital of Southern Medical University:
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Nasopharyngeal Carcinoma cisplatin carboplatin |
Additional relevant MeSH terms:
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Carcinoma Nasopharyngeal Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases |
Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin Carboplatin Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |