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NCT Number: NCT00943423

PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma

RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required.

PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.

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This study is active but is not currently recruiting participants.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

About this study

OBJECTIVES:

  • Determine whether patients with stage IA or IIA Hodgkin lymphoma who have a negative fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging after 3 courses of chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) require consolidation radiotherapy (to areas of previous involvement) in order to delay or prevent disease progression.

OUTLINE: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for 3 courses. On day 15 of the third course of chemotherapy, patients undergo a CT scan of the neck, thorax, abdomen and pelvis. Patients with nonresponsive disease or progressive disease are removed from the study. Patients who achieve response undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET). Patients with a positive FDG-PET scan receive an additional course of ABVD and undergo involved field radiotherapy. Patients with a negative FDG-PET scan are randomized to 1 of 2 treatment arms.

  • Arm I: Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
  • Arm II: Patients receive no further treatment. After completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin Lymphoma
  • Stage IA or IIA disease
  • No stage IA Hodgkin lymphoma with no clinical or CT evidence of disease after diagnostic biopsy
  • Above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass
  • Internal thoracic diameter at level of D5/6 interspace > 0.33
  • Bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months
  • No prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis)
  • Willing to travel to the nearest PET scan center
  • Able to comply with protocol follow-up arrangements

PRIOR CONCURRENT THERAPY:

  • No prior treatment for Hodgkin lymphoma
  • No contraindications to chemotherapy or radiotherapy

Treatment and study plan

Involved Field Radiotherapy

Radiation

IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy

No Further Treatment

Other

Primary outcomes

  1. Progression-free survival

    Time frame: up to 5 years after randomisation

Secondary outcomes

  1. Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy

    Time frame: 3 months after treatment start

  2. Survival and cause of death

    Time frame: up to 5 years after randomisation

  3. Incidence and type of second cancers

    Time frame: up to 5 years after randomisation

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • The Christie NHS Foundation Trust

Registry information

Official study title

A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease

Acronym: RAPID

Important dates

Study start
2003
Primary completion
2014
Study completion
2028
First posted
Jul 22, 2009
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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