Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma

This study has been terminated.
(unexpected high grade of mucositis observed)
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01667289
First received: August 13, 2012
Last updated: March 2, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.


Condition Intervention Phase
Extranodal NK/T-cell Lymphoma, Nasal Type
Radiation: Radiotherapy alone
Drug: Concurrent chemoradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 3-year Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 3-year overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiotherapy alone
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Radiation: Radiotherapy alone
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Experimental: Concurrent chemoradiation

Concurrent chemoradiation

Chemotherapy:

Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy

Radiation: Radiotherapy alone
Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
Drug: Concurrent chemoradiation

Concurrent chemoradiation

Chemotherapy:

Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy

Other Name: MTX

Detailed Description:

Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 18-75 years old
  • Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
  • ECOG performance status 0-1
  • Life expectancy of more than 3 months
  • Adequate bone marrow and organ functions

Exclusion Criteria:

  • non-nasal NK/T-cell lymphoma
  • Prior exposure of methotrexate
  • With third space effusion
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667289

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

No publications provided

Responsible Party: Ye Guo, Assocaite Director of Medical Oncology Department, Fudan University
ClinicalTrials.gov Identifier: NCT01667289     History of Changes
Other Study ID Numbers: LMTG 12-01
Study First Received: August 13, 2012
Last Updated: March 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
NK/T-cell lymphoma
Methotrexate
Radiotherapy
Concurrent chemoradiation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014