PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma (RAPID)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Christie Hospital NHS Foundation Trust
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00943423
First received: July 20, 2009
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.


Condition Intervention Phase
Lymphoma
Radiation: Involved Field Radiotherapy
Other: No further treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy [ Time Frame: 3 months after treatment start ] [ Designated as safety issue: No ]
  • Survival and cause of death [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
  • Incidence and type of second cancers [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]

Enrollment: 602
Study Start Date: July 2003
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
Radiation: Involved Field Radiotherapy
IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy
Experimental: Arm II
Patients receive no further treatment.
Other: No further treatment

Detailed Description:

OBJECTIVES:

  • Determine whether patients with stage IA or IIA Hodgkin lymphoma who have a negative fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging after 3 courses of chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) require consolidation radiotherapy (to areas of previous involvement) in order to delay or prevent disease progression.

OUTLINE: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for 3 courses. On day 15 of the third course of chemotherapy, patients undergo a CT scan of the neck, thorax, abdomen and pelvis. Patients with nonresponsive disease or progressive disease are removed from the study. Patients who achieve response undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET). Patients with a positive FDG-PET scan receive an additional course of ABVD and undergo involved field radiotherapy. Patients with a negative FDG-PET scan are randomized to 1 of 2 treatment arms.

  • Arm I: Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
  • Arm II: Patients receive no further treatment. After completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin Lymphoma

    • Stage IA or IIA disease

      • No stage IA Hodgkin lymphoma with no clinical or CT evidence of disease after diagnostic biopsy
    • Above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass

      • Internal thoracic diameter at level of D5/6 interspace > 0.33
    • Bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months
  • No prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis)
  • Willing to travel to the nearest PET scan center
  • Able to comply with protocol follow-up arrangements

PRIOR CONCURRENT THERAPY:

  • No prior treatment for Hodgkin lymphoma
  • No contraindications to chemotherapy or radiotherapy
  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: NCT00943423

Locations
United Kingdom
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
University College, London
Christie Hospital NHS Foundation Trust
Investigators
Principal Investigator: John Radford, MD Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00943423     History of Changes
Other Study ID Numbers: 03_DOG05_07, CHNT-RAPID, ISRCTN99811594, EU-20931
Study First Received: July 20, 2009
Last Updated: May 9, 2013
Health Authority: United Kingdom: NHS Health Research Authority

Keywords provided by University College, London:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014