CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Vincristine +6 moredrug
Likely dose
Stanford V-C: vincristine 1.4 mg/m² IV weeks 2,4,6,8; cyclophosphamide 650 mg/m² weeks 1,5; doxorubicin 25 mg/m² weeks 1,3,5,7; prednisone 40 mg/m² oral alternating days with taper; bleomycin 5 U/m² IV weeks 2,4,6,8; etoposide 60 mg/m² × 2 IV weeks 3,7; followed by 20 Gy involved-field radiotherapyAI-extracted
Key inclusion· 7
  • ✓Newly diagnosed stage I or IIA Hodgkin lymphoma of nodular sclerosis, mixed cellularity, or classical subtype
  • ✓Age 18–70 years
  • ✓Adequate bone marrow function: absolute neutrophils ≥2000/µL, platelets ≥150,000/µL
  • ✓Adequate hepatic function: bilirubin ≤2.5 mg/dL
Key exclusion· 8
  • ✕Lymphocytic predominance subtype Hodgkin lymphoma
  • ✕Any prior treatment for Hodgkin disease
  • ✕Mediastinal mass ≥1/3 maximum intrathoracic diameter on chest X-ray
  • ✕Any lymph node >10 cm in greatest transaxial diameter

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00026208
NCT00026208Phase 2Completed
CompareCT.gov

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

Stanford University·interventional·Posted Jan 27, 2003·Updated Jul 24, 2018

In Brief

A Phase 2 clinical trial evaluating Vincristine, Cyclophosphamide, and 5 other interventions for Lymphoma, Hodgkin Disease and 3 related conditions. Completed, enrolled 76 participants across 2 sites.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Hodgkin Disease, Lymphoma, Hodgkin Disease, Lymphoma: Hodgkin
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2001
Primary CompletionApr 26, 2013
Study CompletionFeb 13, 2017
TodayJul 2, 2026
Enrollment to primary: 11.9 yearsPosted 23.4 years ago

Interventions

Vincristinedrug

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

Cyclophosphamidedrug

650 mg/m², on week 1 and 5

Doxorubicindrug

25 mg/m², on week 1, 3, 5, 7

Prednisonedrug

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

Bleomycindrug

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

Etoposidedrug

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.