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Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00026208
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 15, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ranjana Advani, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Hodgkin Disease
Lymphoma
Hodgkin Disease
Lymphoma: Hodgkin
Interventions Drug: Vincristine
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Prednisone
Drug: Bleomycin
Drug: Etoposide
Radiation: Low-dose radiotherapy (RT)
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Period Title: Overall Study
Started 72 4
Completed 71 4
Not Completed 1 0
Reason Not Completed
Complications of auto accident             1             0
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only Total
Hide Arm/Group Description

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Total of all reporting groups
Overall Number of Baseline Participants 72 4 76
Hide Baseline Analysis Population Description
Prior to amendment, participants with tumor size < 5 cm received Stanford V-C only. Subsequent to amendment, all participants received Stanford V-C + low-dose radiotherapy (RT)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 4 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
70
  97.2%
4
 100.0%
74
  97.4%
>=65 years
2
   2.8%
0
   0.0%
2
   2.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 4 participants 76 participants
Female
43
  59.7%
2
  50.0%
45
  59.2%
Male
29
  40.3%
2
  50.0%
31
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 4 participants 76 participants
72 4 76
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description 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.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Does not include those participants whose treatment was significantly modified due to accidental injury; or who were lost-to-follow-up.
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 70 4
Measure Type: Number
Unit of Measure: percentage of participants
89.7 50
2.Secondary Outcome
Title Frequency of Complete Response
Hide Description 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).
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants, for whom a PET-CT scan was not conducted in week 4 to 5 of treatment, were not included.
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 38 0
Measure Type: Count of Participants
Unit of Measure: Participants
31
  81.6%
3.Secondary Outcome
Title Early Treatment-related Toxicity
Hide Description 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.
Time Frame Within 30 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 72 4
Measure Type: Number
Unit of Measure: treatment-related adverse events
422 24
4.Secondary Outcome
Title Late Treatment-related Toxicity
Hide Description 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.
Time Frame 16 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 72 4
Measure Type: Number
Unit of Measure: treatment-related adverse events
Second Cancer 2 0
Hypothyroidism 19 0
5.Secondary Outcome
Title Second Hodgkin's Disease Progression
Hide Description 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.
Time Frame 16 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data to confirm Hodgkin's disease 2nd progression was not available for some participants.
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 69 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.3%
1
  25.0%
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.
Time Frame 16 years
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants, except those whose treatment was significantly modified due to accidental injury. Subjects who became lost-to-follow-up were censored at their last known value.
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 71 4
Median (Full Range)
Unit of Measure: years
10.4
(0.7 to 15.5)
13.2
(1.8 to 13.9)
7.Secondary Outcome
Title Survival at 5 and 10 Years
Hide Description Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.
Time Frame 5 and 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
For overall survival at 5 and 10 years, this analysis does not include those participants known to be alive, but whose diagnosis was less than 5 or 10 years prior to current date or last date known alive, respectively.
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description:

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
Overall Number of Participants Analyzed 69 4
Measure Type: Count of Participants
Unit of Measure: Participants
5 years Number Analyzed 69 participants 4 participants
67
  97.1%
3
  75.0%
10 years Number Analyzed 46 participants 4 participants
41
  89.1%
3
  75.0%
Time Frame 16 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Hide Arm/Group Description

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

"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.

"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

  • Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
  • Cyclophosphamide: 650 mg/m², on week 1 and 5
  • Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
  • Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
  • Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
  • Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
All-Cause Mortality
Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Affected / at Risk (%) Affected / at Risk (%)
Total   7/72 (9.72%)      0/4 (0.00%)    
Hide Serious Adverse Events
Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/72 (34.72%)      2/4 (50.00%)    
Cardiac disorders     
Atrial fibrillation  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  17/72 (23.61%)  17 2/4 (50.00%)  2
General disorders     
Fever  1  5/72 (6.94%)  6 1/4 (25.00%)  1
Injury, poisoning and procedural complications     
Crush injury, automobile accident  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Second cancer  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  1/72 (1.39%)  1 0/4 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stanford V-C + Low-dose Radiotherapy Stanford V-C Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/72 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders     
Infection with grade 3 ANC grade 2 ATT (no hospitalization)  1  1/72 (1.39%)  1 0/4 (0.00%) 
Febrile Neutropenia  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Gastrointestinal disorders     
Nausea and Vomiting  1  4/72 (5.56%)  4 0/4 (0.00%)  0
Metallic Taste in Mouth  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Dry Mouth  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Oral Mucositis  1  7/72 (9.72%)  7 0/4 (0.00%)  0
Mild Oral Sensitivity  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Oral Toxicity  1  8/72 (11.11%)  8 0/4 (0.00%)  0
Epigastric pain  1  26/72 (36.11%)  26 1/4 (25.00%)  1
Nausea  1  51/72 (70.83%)  51 2/4 (50.00%)  2
Constipation  1  40/72 (55.56%)  40 3/4 (75.00%)  3
Rectal ulcer  1  0/72 (0.00%)  0 1/4 (25.00%)  1
Dysphagia  1  0/72 (0.00%)  0 1/4 (25.00%)  1
Heartburn  1  1/72 (1.39%)  1 2/4 (50.00%)  2
Gas pains  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Vomiting  1  18/72 (25.00%)  18 1/4 (25.00%)  1
General disorders     
Fatigue/Malaise  1  58/72 (80.56%)  58 3/4 (75.00%)  3
Fever  1  3/72 (4.17%)  3 0/4 (0.00%)  0
Insomnia  1  27/72 (37.50%)  27 0/4 (0.00%)  0
Tenderness at the PICC site  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Discomfort, burning & increased sensitivity  1  1/72 (1.39%)  1 0/4 (0.00%)  0
PICC line removed  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Chest soreness and tightness  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, inflammation of left arm above IV site  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Aches and pains  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, axilla & breast  1  0/72 (0.00%)  0 1/4 (25.00%)  1
Sorness in upper and lower extremities  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Substernal chest pressure  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, abdominal  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, jaw  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Pain, hips and legs  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Joint pains, back and hips  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Ache and heaviness in left arm  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, right groin  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain  1  3/72 (4.17%)  3 0/4 (0.00%)  0
Generalized achiness  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Flu-like symptoms  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, related to PICC  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Weight loss  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Chills  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Infections and infestations     
Fungal rash  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Infection  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Investigations     
Lymphocyte count decreased  1  55/72 (76.39%)  101 4/4 (100.00%)  11
Neutrophil count decreased  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Neutrophil count decreased  1  41/72 (56.94%)  48 2/4 (50.00%)  3
Metabolism and nutrition disorders     
Alanine aminotransferase increased  1 [1]  1/72 (1.39%)  1 0/4 (0.00%)  0
Anorexia  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone pain  1  5/72 (6.94%)  5 0/4 (0.00%)  0
Pain, bilateral arms  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Myalgias  1  3/72 (4.17%)  3 0/4 (0.00%)  0
Pain, bone and muscle  1  4/72 (5.56%)  4 0/4 (0.00%)  0
Muscle aches  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Pain, lower back  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Arthralgias  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Nervous system disorders     
Peripheral Sensory Neuropathy  1  40/72 (55.56%)  40 3/4 (75.00%)  3
Peripheral Motor Neuropathy  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Syncopal episode with brief loss of consciousness  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Altered taste sensation  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Headache  1  4/72 (5.56%)  4 1/4 (25.00%)  1
Dizziness  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Headache  1  1/72 (1.39%)  1 1/4 (25.00%)  1
Psychiatric disorders     
Depression  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Anxiety  1  3/72 (4.17%)  3 0/4 (0.00%)  0
Mood Alteration  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Renal and urinary disorders     
Blood spotting  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Gross hematuria  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Diaphoresis  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Skin toxicity  1  2/72 (2.78%)  2 0/4 (0.00%)  0
Rash  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Swelling  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Vascular disorders     
Acute Pulmonary Embolism  1  1/72 (1.39%)  1 0/4 (0.00%)  0
Vein Pain  1  6/72 (8.33%)  6 1/4 (25.00%)  1
Phlebitis  1  1/72 (1.39%)  1 0/4 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Secondary to automobile accident
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jessica C Lam, BS
Organization: Stanford Univeristy Medical Center
Phone: 650-723-0437
EMail: jclam11@stanford.edu
Layout table for additonal information
Responsible Party: Ranjana Advani, Stanford University
ClinicalTrials.gov Identifier: NCT00026208    
Other Study ID Numbers: IRB-13081
LYMHD0002 ( Other Identifier: OnCore )
First Submitted: November 9, 2001
First Posted: January 27, 2003
Results First Submitted: March 16, 2018
Results First Posted: May 15, 2018
Last Update Posted: July 24, 2018