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

Radiotherapy = 20 Gy modified involved field radiotherapy

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

1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8

40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy

5 u/m² intravenously (IV) on week 2, 4, 6, 8

60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

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.

Low-dose radiotherapy (RT)

Ranjana H Advani, MD

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.

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.

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.

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

Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study

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.

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).

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.

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.

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.

Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.

Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.

Stanford University

Saul A. Rosenberg, MD, Professor of Lymphoma

"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 + Low-dose Radiotherapy

"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)

Stanford V-C Only

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

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)

Jessica C Lam, BS

Does not include those participants whose treatment was significantly modified due to accidental injury; or who were lost-to-follow-up.

Progression-free Survival (PFS)

Participants, for whom a PET-CT scan was not conducted in week 4 to 5 of treatment, were not included.

Frequency of Complete Response

Early Treatment-related Toxicity

Second Cancer

Hypothyroidism

Late Treatment-related Toxicity

Data to confirm Hodgkin's disease 2nd progression was not available for some participants.

Second Hodgkin's Disease Progression

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.

Overall Survival (OS)

5 years

10 years

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma	NCT00026208	Lymphoma, Hodgk... Lymphoma Hodgkin Disease Lymphoma: Hodgk...	Vincristine Cyclophosphamid... Doxorubicin Prednisone Bleomycin Etoposide Low-dose radiot...	18 Years - 70 Years	Stanford University
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma	NCT00026208	Lymphoma, Hodgk... Lymphoma Hodgkin Disease Lymphoma: Hodgk...	Vincristine Cyclophosphamid... Doxorubicin Prednisone Bleomycin Etoposide Low-dose radiot...	18 Years - 70 Years	Stanford University

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