NCT00817258

Brief Summary

The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy. Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 6, 2009

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

January 2, 2009

Last Update Submit

January 5, 2009

Conditions

Nasopharyngeal Carcinoma

Keywords

Phase 2 Clinical TrialNPCradiation therapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 and 5 years

Secondary Outcomes (1)

  • disease-free survival, and distant metastases free survival

    3 and 5 years

Study Arms (1)

1

OTHER

All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.

Drug: cisplatinRadiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

Interventions

cisplatinDRUG

Cisplatin 40mg/m2,weekly

1
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)RADIATION

3D-CRT or IMRT

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
  • Stage II disease (T1-2; N1; M0)
  • KPS \>70
  • Age between 18-70
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \< 1.5 mg/dl, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min.
  • No prior radiation treatment to the head and neck or any prior chemotherapy
  • Patients with no prior malignancy (not include basal cell carcinoma of skin)

You may not qualify if:

  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Prior radiotherapy to the head and neck region for any reason.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
  • Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

CisplatinRadiotherapy, ConformalRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Lin Kong, MD

    Department of Radiation Oncology, Cancer Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

  • Chaosu Hu, MD

    Department of Radiation Oncology, Cancer Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Kong, MD

CONTACT

8621-64175590konglinj@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 6, 2009

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

January 6, 2009

Record last verified: 2009-01

Locations

CN(1)