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

• 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: Stanford University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Stanford V-C + Low-dose Radiotherapy	Stanford V-C Only
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

Baseline Characteristics

Arm/Group Title		Stanford V-C + Low-dose Radiotherapy	Stanford V-C Only	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stanford V-C + Low-dose Radiotherapy	Stanford V-C Only
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stanford V-C + Low-dose Radiotherapy	Stanford V-C Only
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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%

Adverse Events

Time Frame	16 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Stanford V-C + Low-dose Radiotherapy		Stanford V-C Only
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Jessica C Lam, BS
• Organization: Stanford Univeristy Medical Center
• Phone: 650-723-0437
• EMail: jclam11@stanford.edu

• 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