NCT01132807|CompletedPhase 2Results

Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

CALGB-50604NCI-2011-02042U10CA180821CDR0000672913

Study Type

interventional

Target

164

Locations

1 country

Sites

Timeline

RegisteredMay 2010

StartedMay 2010

CompletionJan 2018

Brief Summary

This phase II trial studies how well chemotherapy based on positron emission tomography (PET) scan works in treating patients with stage I or stage II Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

164

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started May 2010

Typical duration for phase_2 lymphoma

Geographic Reach

1 country

95 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

June 14, 2021

Completed

Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

5.8 years

First QC Date

May 27, 2010

Results QC Date

October 24, 2018

Last Update Submit

June 10, 2021

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included.
36 Months
36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT.
at 36 months

Secondary Outcomes (1)

Complete Response Rate
Up to 5 years

Study Arms (1)

Treatment (chemotherapy and F-18 PET/CT)

EXPERIMENTAL

See Detailed Description

Biological: Bleomycin SulfateDrug: Doxorubicin HydrochlorideDrug: Procarbazine HydrochlorideDrug: Vinblastine SulfateDrug: DacarbazineDrug: CyclophosphamideDrug: Etoposide phosphateDrug: prednisoneDrug: Radiation TherapyRadiation: Fludeoxyglucose F-18Procedure: computed tomographyProcedure: Positron Emission Tomography