Hodgkin Lymphoma Clinical Trial
Official title:
A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease
Verified date | April 2020 |
Source | Canadian Cancer Trials Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.
Combining more than one drug or combining chemotherapy with radiation therapy may kill more
tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with
or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage
IIA Hodgkin's disease.
Status | Completed |
Enrollment | 405 |
Est. completion date | January 6, 2012 |
Est. primary completion date | August 15, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Eligibility Criteria - Histologically proven Hodgkin's Disease. A needle aspirate specimen will not be considered sufficient for diagnosis. - Pathologic material must have been reviewed by a designated local reference pathologist (LRP) prior to randomization. Histologic subtype determined by the LRP will be used for patient cohort assignment. - Patients must have clinical stage I - IIA disease according to Ann Arbor staging criteria. Clinical stage must be based on at least one tissue biopsy. The following aspects are to be considered in determining patient stage: i) Splenic Enlargement: Splenic enlargement determined by imaging studies only should not be considered evidence of splenic involvement with Hodgkin's disease. Patients should be considered as having splenic involvement if the spleen is palpable on physical examination and enlarged on imaging studies, or imaging studies show focal abnormalities consistent with Hodgkin's disease. These patients, if presenting with supradiaphragmatic disease would therefore be assessed as having Stage III disease and would be ineligible. ii) Bone Disease: Lytic or blastic lesions seen on plain radiographs or abnormalities on bone scan consistent with Hodgkin's disease will be considered as bone involvement with Hodgkin's disease. These patients would therefore be assessed as having Stage IV disease and would be ineligible. iii) Pleural Effusion and Ascites: The presence of a pleural effusion or ascites will be considered as evidence of Hodgkin's disease even if cytological examination is negative. These patients would be assessed as having probable Stage IV disease and therefore would be ineligible. Patients assessed on Xray as having pleural thickening or "blunting" of the costophrenic angle only may be eligible. iv) Extra-nodal vs. Stage IV Disease: Patients with disease involving a single extra-nodal site may be considered as "limited-stage" provided all disease can be included in a standard radiation field. Patients with extra-nodal disease that cannot be included in such a field (eg, lung, bone) or with multiple sites of extra-nodal disease are not eligible for this trial. - Pulmonary function tests must be done in patients with symptomatic lung disease. FVC, FEV-1 and DLCO must be = 60% of predicted value. Patients with asthma controlled by medication are eligible if the above criteria are met. - Patient's age is = 16 years. (Note that the lower age limit at each centre will be determined by that centre's policy regarding the age at which an individual may sign their own consent.) - Patient must not have received previous chemotherapy or radiotherapy. - Laboratory requirements: granulocytes = 1.5 x 109/L (S.I.) or = 1.5 x 103/uL (U.S.) platelets = 125 x 109/L (S.I.) or = 125 x 103/uL (U.S.) bilirubin = 2.5 x UNL (unless due to hemolytic anemia) serum creatinine = 2 x UNL - Patient must have been seen by both a radiation oncologist and medical oncologist who agree the patient is able to receive protocol radiation therapy. - Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Clinical Trials Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for the NCICCTG and monitoring agencies to review patient records. - Availability of patient for follow-up and quality of life (QoL) assessments. Patients must be accessible for treatment and follow-up. Investigators must assure themselves that patients registered on this trial will be available for complete documentation of the treatment, toxicity and follow-up. Comparison of quality of life is an end-point of this study. Patients must have completed the pre-randomization quality of life assessment and be willing to complete future assessments. The only exceptions will be patients who are unable to read english or french. Patients on study are expected to complete all the quality of life assessments but, should this not prove possible, they will be retained in the study for all other analyses. Ineligibility Criteria - Prior or concurrent malignancies, except adequately treated basal cell carcinoma of the skin. (Patients with prior carcinoma-in-situ of the cervix are not eligible.) - Cardiac disease defined as symptomatic congestive heart failure or coronary artery disease, known valvular (other than asymptomatic mitral valve prolapse) or congenital heart disease (other than asymptomatic atrial septal defects) or need for cardiac medications. Hypertension controlled with drug therapy is not an exclusion criterion. - Other major medical illness judged likely by the local investigator to preclude safe administration of protocol treatment or required follow-up. - Patients with stage IA disease (who might be treated with involved-field only irradiation) defined by meeting all of the following criteria: i) lymphocyte predominant or nodular sclerosing histology ii) disease bulk < 3 cm iii) erythrocyte sedimentation rate (ESR) < 50 iv) unilateral high - neck only disease, defined as disease located above the upper border of the thyroid cartilage or isolated epitrochlear adenopathy - Patients with very unfavourable clinical stage I-IIA disease defined as bulky adenopathy. Bulky adenopathy is defined as a palpable nodal mass greater than 10 cm. in diameter or a mediastinal mass with a maximum mass diameter measuring greater than or equal to 1/3 the maximum chest wall diameter (see Appendix III). - Patients with intra-abdominal disease. (Patients with pelvic disease: ileofemoral, inguinal or parailiac nodes are eligible for this study.) - Patients with B symptoms. - Patients known to have a positive antibody test for the human immunodeficiency virus (HIV) or who have a clinical diagnosis of acquired immunodeficiency syndrome. HIV testing is not a requirement for study entry. - Patients who have undergone a staging laparotomy. - Female patients who are pregnant. Note: men and women of childbearing age must be advised in the use of adequate contraception. |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Trillium Health Partners - Credit Valley Hospital | Mississauga | Ontario |
Canada | The Vitalite Health Network - Dr. Leon Richard | Moncton | New Brunswick |
Canada | CIUSSS de l'Est-de-I'lle-de-Montreal | Montreal | Quebec |
Canada | Stronach Regional Health Centre at Southlake | Newmarket | Ontario |
Canada | Lakeridge Health Oshawa | Oshawa | Ontario |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Regional Health Authority B, Zone 2 | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Algoma District Cancer Program | Sault Ste. Marie | Ontario |
Canada | Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador |
Canada | Health Sciences North | Sudbury | Ontario |
Canada | Humber River Hospital | Toronto | Ontario |
Canada | Sinai Health System | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Canada | BCCA - Vancouver Island Cancer Centre | Victoria | British Columbia |
Italy | Instituto del Radio O. Alberti Spedali Civili | Brescia | |
Italy | Policlinico Monteluce/Univ. Degli Studi Di Perugia | Perugia | |
United Kingdom | Royal South Hants Hospital | Southampton |
Lead Sponsor | Collaborator |
---|---|
NCIC Clinical Trials Group | Eastern Cooperative Oncology Group |
Canada, Italy, United Kingdom,
Macdonald DA, Ding K, Gospodarowicz MK, Wells WA, Pearcey RG, Connors JM, Winter JN, Horning SJ, Djurfeldt MS, Shepherd LE, Meyer RM. Patterns of disease progression and outcomes in a randomized trial testing ABVD alone for patients with limited-stage Hod — View Citation
Macdonald DA, Gospodarowicz MK, Wells WA, et al.: Relapse patterns and subsequent outcomes of patients treated on the NCIC CTG HD.6 (ECOG JHD06) randomized trial evaluating ABVD alone in patients with limited stage Hodgkin's lymphoma (HL). [Abstract] Bloo
Meyer R, Gospodarowicz M, Connors J, et al.: A randomized phase III comparison of single - modality ABVD with a strategy that includes radiation therapy in patients with early-stage Hodgkin's disease: the HD-6 trial of the National Cancer Institute of Can
Meyer RM, Gospodarowicz MK, Connors JM, Pearcey RG, Bezjak A, Wells WA, Burns BF, Winter JN, Horning SJ, Dar AR, Djurfeldt MS, Ding K, Shepherd LE; National Cancer Institute of Canada Clinical Trials Group; Eastern Cooperative Oncology Group. Randomized c — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | 12 year survival comparison | 12 years | |
Secondary | Freedom from progression | 12 years | ||
Secondary | Complete response rate | 12 years | ||
Secondary | Second disease progression rate | 5 and 10 years | ||
Secondary | Cause-specific survival rate | treatment-related toxicity and Quality of Life. | 5 and 10 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
Active, not recruiting |
NCT03617666 -
Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study
|
Phase 2 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Recruiting |
NCT02507479 -
Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
|
Phase 2 | |
Active, not recruiting |
NCT02191930 -
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
|
Phase 2 | |
Completed |
NCT01943682 -
Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma
|
Phase 1 | |
Completed |
NCT01393106 -
Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma
|
Phase 2 | |
Terminated |
NCT00992030 -
R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma
|
Phase 3 | |
Terminated |
NCT00722865 -
Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma
|
Phase 2 | |
Unknown status |
NCT00598624 -
Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)
|
Phase 2 | |
Completed |
NCT03242902 -
To Decrease Fatigue With Light Therapy
|
Phase 3 | |
Active, not recruiting |
NCT05205512 -
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
|
N/A | |
Recruiting |
NCT03681561 -
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03250962 -
SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
|
Phase 2 | |
Recruiting |
NCT04510610 -
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
|
Phase 2/Phase 3 | |
Completed |
NCT06295211 -
Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
|
||
Active, not recruiting |
NCT02256137 -
A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
|
||
Completed |
NCT02432235 -
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
|
Phase 1 |