Clinical trial · Observational

Biomarker Analysis Data From a Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma Treated With Chemotherapy and Radiotherapy

Clinical and Biomarker Analysis Data From a Previously Pubished Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma

NCT07741110CI-TRIAL-00120286completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Clinicopathological and genomic data (Next generation sequencing and IHC/CISH) in available tissues were performed in patients with nasopharyngeal carcinoma who participated in a previously conducted randomized phase II study that evaulated induction chemotherapy followed by CCRT with CCRT alone.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Nasopharyngeal Carcinoma (NPC)	Nasopharyngeal Carcinoma	ONTOLOGY_EXACT	0.85

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Immunohistochemistry/CISH	Genetic	—	UNRESOLVED
Next generation sequencing	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Induction chemotherapy followed by cisplatin-based chemoradiotherapy
description
Induction chemotherapy: 3 cycles of epirubicin 75 mg/m2 followed by paclitaxel 175 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 2. Each cycle is repeated every 3 weeks. Followed by RT concomitant with cisplatin 40 mg/m2 weekly, 1-2 h before RT
label
Cisplatin-based chemoradiotherapy
description
RT concomitant with cisplatin 40 mg/m2 weekly, 1-2 h before RT

Primary outcomes (1)

measure
Risk factors associated with survival
timeFrame
3 years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 15 Years

Show eligibility criteria text

Inclusion Criteria:

* biopsy-proven, previously untreated WHO type I, II or III NPC;
* age \> or equal to 15 years
* stage IIB-IVB according to the American Joint Committee on Staging of Cancer classification (AJCC 2002);
* measurable or evaluable disease
* no other primary tumors
* performance status (PS) of 0-2 according to the Eastern Cooperative Oncology Group scale (ECOG)
* adequate bone marrow, hepatic, renal and pulmonary function
* adequate nutritional status to tolerate protocol treatment and
* adequate mental status to follow instructions, keep appointments and provide written informed consent.

Exclusion Criteria:

* Secondary malignancies
* age\< 15 years
* ECOG PS 3-4
* Renal, hepatic, hematologic or pulmonary insufficiency

References

Publications (0)

Data not yet available

No reference posted for this study.