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Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma (WUCC-NHL02)

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ClinicalTrials.gov Identifier: NCT02438501
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Di Deng, Wuhan University

Brief Summary:
Many trials that patients with advanced or recurrent indolent lymphoma managed with very low-dose (4Gy) limited-field RT (LD-IFRT) have shown that high response rates and durable remission can be achieved. However, the results of two phase III trials have failed to demonstrate the lasting response rate (RR) with LD-IFRT versus in other approaches. Histology, bulky tumor (>5 cm), higher number of prior chemotherapy regimens, adoption of rituximab, and age>65 years have been shown to significantly influence response rates of LD-IFRT. The objectives of this trial investigate the efficacy of palliative low-dose involved-field radiation therapy in patients lower than 65 years of age with recurrent advanced follicular lymphoma.

Condition or disease Intervention/treatment Phase
Recurrent Follicular Lymphoma Radiation: Low-dose involved-field radiotherapy Radiation: Involved-field radiotherapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label, Multi-center Study of Efficacy of Palliative Low-Dose Involved-Field Radiation Therapy for Recurrent Advanced Follicular Lymphoma: Wuhan University Cancer Center -NHL02 Trial
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: LD-IFRT group
Chemotherapy / Low-dose involved-field radiotherapy
Radiation: Low-dose involved-field radiotherapy
Low-dose involved-field RT (LD-IFRT) is given in 2 daily fractions (2×2 Gy). Involved-field of radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor.

Active Comparator: IFRT group
Chemotherapy / Involved-field radiotherapy
Radiation: Involved-field radiotherapy
Involved-field RT (IFRT) is given in 24 Gy in 12 fractions. Radiotherapy field defined by CALGB is encompassed the prechemotherapy gross tumor.




Primary Outcome Measures :
  1. Overall response rates - ORR [ Time Frame: At day 30 after radiotherapy ]
  2. Time to treatment failure - TTF [ Time Frame: From the start of radiotherapy to the first documented disease progression or death from any cause, whichever occurs first, Assessed up to 40 months. ]
  3. Number of participants with adverse events with grade 3 or 4 - AEs [ Time Frame: The time from the day of treatment to the day of the first documented disease progression or death from any cause, Assessed up to 24 months. ]
    Toxicity was scored according to the toxicity scale of the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0.


Secondary Outcome Measures :
  1. Overall survival - OS [ Time Frame: From the initial diagnosis of follicular lymphoma to death from any cause, Assessed up to 100 months. ]
  2. Rate of in-field progression [ Time Frame: From the start of RT to the first documented disease progression within the radiotherapy portal, Assessed up to 24 months. ]
  3. Rate of out-field progression [ Time Frame: From the start of RT to the first documented disease progression outside the radiotherapy field, Assessed up to 40 months. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both male and female aged range from 18 years to 65 years.
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
  • All patients had histological confirmed follicular lymphoma Grade 1 or 2.
  • Recurrent patient with stage III and IV after initial management.
  • Had the indications for treatment provided by GELA.
  • Rituximab is too expensive to be managed for the patient.
  • Adequate organ function.
  • Negative pregnancy test.
  • Signed informed consent document on file.

Exclusion Criteria:

  • Woman who were pregnant or lactating.
  • Had uncontrolled metastases in central nervous system.
  • With severe local infection or general infective disease.
  • Immunotherapy for the treatment of follicular lymphoma within 1 month prior to the start of this trial.
  • With other second primary malignancy except cutaneum carcinoma.
  • Being or planing to participate in other study.
  • Any patient who in the opinion of the investigator should not participate in the study.

Withdrawal Criteria:

  • Patient are free to withdrawal completely from the study at any time upon request.
  • Patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
  • Continual consolidation chemotherapy after irradiation within the follow-up period.
  • In-field progression on irradiation ongoing.
  • Poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.

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): NCT02438501


Contacts
Contact: Di Deng, MD 0086-27-67813153 dengdi69@163.com
Contact: Liyong Zou, MD 0086-18908601687 zouliyong@csco.org.cn

Locations
China, Hubei
DiDeng Recruiting
Wuhan, Hubei, China, 430071
Sponsors and Collaborators
Di Deng

Responsible Party: Di Deng, Associate Professor, Director of Research, Wuhan University
ClinicalTrials.gov Identifier: NCT02438501     History of Changes
Other Study ID Numbers: WuhanU
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Di Deng, Wuhan University:
low-dose involved field radiotherapy
recurrent
advanced
follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin