PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma (RAPID)
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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 |
- Progression-free survival [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
- 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 |
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| United Kingdom | |
| Christie Hospital | |
| Manchester, England, United Kingdom, M20 4BX | |
| 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 Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013