Lymphoma, Hodgkin DiseasePhase 2NCT00026208
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
A Phase 2 study testing Vincristine, Cyclophosphamide and Doxorubicin in people with Lymphoma, Hodgkin Disease and Lymphoma, run by Stanford University at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, Hodgkin Disease, Lymphoma, Hodgkin Disease
- What is being tested?
- Vincristine, Cyclophosphamide and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2001to 13 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes
- Nodular sclerosis
- Mixed cellularity
- Classical, not otherwise specified
- Age ≥ 18 years and ≤ 70 years
- Granulocytes ≥ 2 x 10e6/µL
Show all 14Show fewer
- Platelets ≥ 150 x 10e6/µL
- Bilirubin ≤ 2.5 mg/dL
- Serum creatinine ≤ 2 mg/dL
- Patients > 50 years or those with a history of cardiac disease should have an ejection fraction ≥ 50%
- All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment
- Pathologic material reviewed at Stanford University
- Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the Hodgkin's Disease Staging Conference
- Written informed consent
Who cannot join
- Lymphocytic predominance Hodgkin's disease
- Prior treatment for Hodgkin's disease
- Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
- Any lymph node mass > 10 cm in greatest trans-axial diameter
- Two or more extranodal sites of disease
- Constitutional (B) symptoms present at diagnosis
Show all 10Show fewer
- Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of the skin)
- Any medical contraindication to the planned treatment, including:
- Pregnant
- Positive antibody test for the human immunodeficiency virus (HIV)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University School of Medicine
Stanford, California, 94305
Kaiser Permanente Medical Center
Vallejo, California, 94589
About this study
Official title: Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy (RT).
- Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of RT to moderately bulky sites of disease.
- Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.
Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.
Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Being tested
- Vincristine, Cyclophosphamide, Doxorubicin, Prednisone, Bleomycin
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
Also called Vinblastine, Leurocristine sulfate, Oncovin, Vincasar
1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
CyclophosphamideDrug
Also called Cytoxan, Neosar, Cyclophosphamidum, Cyclophosphamid
650 mg/m², on week 1 and 5
DoxorubicinDrug
Also called Adriamycin, Doxorubicinum, Doxorubicine, Rubex
25 mg/m², on week 1, 3, 5, 7
PrednisoneDrug
Also called Dehydrocortisone, Deltasone, Liquid Pred, Meticorten
40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy
BleomycinDrug
Also called Bleomycin A2, Bleomycine, Bleocin, Bleomicin
5 u/m² intravenously (IV) on week 2, 4, 6, 8
EtoposideDrug
Also called Toposar, Etopophos, Vepesid, VP-16
60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Low-dose radiotherapy (RT)Radiation
20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| Stanford V-C + Low-dose Radiotherapy | Experimental | "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
Radiotherapy = 20 Gy modified involved field radiotherapy Receives: Drug: Vincristine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Bleomycin; Drug: Etoposide; Radiation: Low-dose radiotherapy (RT) |
| Stanford V-C only | Experimental | "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. Receives: Drug: Vincristine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Bleomycin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
Measured: up to 3 years
Secondary outcomes (6)
Frequency of Complete Response
The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT).
Measured: 5 weeks
Early Treatment-related Toxicity
Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment.
Measured: Within 30 days of treatment
Late Treatment-related Toxicity
Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis.
Measured: 16 years
Second Hodgkin's Disease Progression
Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis.
Measured: 16 years
Overall Survival (OS)
Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.
Measured: 16 years
Survival at 5 and 10 Years
Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.
Measured: 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Primary completion26 Apr 2013
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with tumors 5 to 10 cm were to be assigned to concurrent radiotherapy, and participants with tumors less than 5 cm were initially planned to not receive radiotherapy.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranjana Advani, Stanford University
- Investigators
- Ranjana H Advani, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026208
- Sponsor's protocol ID
- IRB-13081
- Other IDs
- LYMHD0002
- Status last verified
- Jun 2018
- First submitted
- 9 Nov 2001
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
- ClinicalTrials.gov ID
- NCT00026208
- Acronym / sponsor ID
- IRB-13081
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- 26 Apr 2013 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 15 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy (RT).
- Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of RT to moderately bulky sites of disease.
- Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.
Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.
Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with tumors 5 to 10 cm were to be assigned to concurrent radiotherapy, and participants with tumors less than 5 cm were initially planned to not receive radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Stanford V-C + Low-dose Radiotherapy | Experimental | Drug: Vincristine, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone, Drug: Bleomycin, Drug: Etoposide, Radiation: Low-dose radiotherapy (RT)"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. Radiotherapy = 20 Gy modified involved field radiotherapy |
| Stanford V-C only | Experimental | Drug: Vincristine, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone, Drug: Bleomycin, Drug: Etoposide"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes
- Age ≥ 18 years and ≤ 70 years
- Granulocytes ≥ 2 x 10e6/µL
- Platelets ≥ 150 x 10e6/µL
- Bilirubin ≤ 2.5 mg/dL
Key exclusion criteria (10 listed)
- Lymphocytic predominance Hodgkin's disease
- Prior treatment for Hodgkin's disease
- Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
- Any lymph node mass > 10 cm in greatest trans-axial diameter
- Two or more extranodal sites of disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VincristineAlso: Vinblastine, Leurocristine sulfate, Oncovin, Vincasar1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8 | Drug | Stanford V-C + Low-dose Radiotherapy, Stanford V-C only |
| CyclophosphamideAlso: Cytoxan, Neosar, Cyclophosphamidum, Cyclophosphamid650 mg/m², on week 1 and 5 | Drug | Stanford V-C + Low-dose Radiotherapy, Stanford V-C only |
| DoxorubicinAlso: Adriamycin, Doxorubicinum, Doxorubicine, Rubex25 mg/m², on week 1, 3, 5, 7 | Drug | Stanford V-C + Low-dose Radiotherapy, Stanford V-C only |
| PrednisoneAlso: Dehydrocortisone, Deltasone, Liquid Pred, Meticorten40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy | Drug | Stanford V-C + Low-dose Radiotherapy, Stanford V-C only |
| BleomycinAlso: Bleomycin A2, Bleomycine, Bleocin, Bleomicin5 u/m² intravenously (IV) on week 2, 4, 6, 8 | Drug | Stanford V-C + Low-dose Radiotherapy, Stanford V-C only |
| EtoposideAlso: Toposar, Etopophos, Vepesid, VP-1660 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44) | Drug | Stanford V-C + Low-dose Radiotherapy, Stanford V-C only |
| Low-dose radiotherapy (RT)20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen. | Radiation | Stanford V-C + Low-dose Radiotherapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 3 years
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
6 secondary outcomes
Frequency of Complete Response
Time frame: 5 weeks
Early Treatment-related Toxicity
Time frame: Within 30 days of treatment
Late Treatment-related Toxicity
Time frame: 16 years
Second Hodgkin's Disease Progression
Time frame: 16 years
Overall Survival (OS)
Time frame: 16 years
Survival at 5 and 10 Years
Time frame: 5 and 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjana H Advani, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vincristine, Cyclophosphamide and Doxorubicin in people with Lymphoma, Hodgkin Disease and Lymphoma, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.