PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma (RAPID)
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|ClinicalTrials.gov Identifier: NCT00943423|
Recruitment Status : Active, not recruiting
First Posted : July 22, 2009
Last Update Posted : October 23, 2019
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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 or disease||Intervention/treatment||Phase|
|Lymphoma||Radiation: Involved Field Radiotherapy Other: No further treatment||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||602 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2028|
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
- Progression-free survival [ Time Frame: up to 5 years after randomisation ]
- Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy [ Time Frame: 3 months after treatment start ]
- Survival and cause of death [ Time Frame: up to 5 years after randomisation ]
- Incidence and type of second cancers [ Time Frame: up to 5 years after randomisation ]
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|Ages Eligible for Study:||16 Years to 75 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
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): NCT00943423
|Manchester, England, United Kingdom, M20 4BX|
|Principal Investigator:||John Radford, MD||The Christie NHS Foundation Trust|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University College, London|
|Other Study ID Numbers:||
|First Posted:||July 22, 2009 Key Record Dates|
|Last Update Posted:||October 23, 2019|
|Last Verified:||October 2019|
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
Neoplasms by Histologic Type
Immune System Diseases