Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

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Brief Title

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

Official Title

Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study

Brief Summary

      This phase III clinical trial is studying how well cisplatin-based chemotherapy and/or
      surgery works in treating young patients with stage I, stage II, stage III or stage IV
      adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
      Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal
      tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain
      after surgery.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. Describe the outcome of patients with stage I adrenocortical tumor (ACT) treated with
      surgery alone.

      II. Describe the outcome of patients with stage II ACT treated with radical adrenalectomy
      plus regional retroperitoneal lymph node dissection.

      III. Describe the outcome of patients with unresectable or metastatic ACT treated with
      mitotane and a cisplatin-based chemotherapy regimen.

      SECONDARY OBJECTIVES:

      I. Determine the feasibility and complications associated with the use of radical
      adrenalectomy and regional node dissection (RLND) in these patients.

      II. Determine the toxicity of mitotane when administered with cisplatin, etoposide, and
      doxorubicin hydrochloride in patients with residual disease after surgery, inoperable tumors,
      or metastatic disease at diagnosis.

      III. Determine, prospectively, the frequency of tumor spillage during surgery in these
      patients.

      IV. Determine the frequency of lymph node involvement in these patients. V. Compare the
      incidence and type of germline p53 mutation in non-Brazilian children and children from
      Southern Brazil.

      VI. Characterize the cooperating molecular alterations associated with ACT. VII. Determine
      the presence of embryonal markers in children with ACT.

      OUTLINE:

      STRATUM I (stage I disease): Patients undergo primary tumor resection and retroperitoneal
      lymph node sampling followed by observation. Patients who have undergone prior surgery
      without nodal sampling undergo observation only.

      STRATUM II (stage II disease): Patients undergo primary tumor resection and extended regional
      lymph node dissection followed by observation. Patients who have undergone prior surgery with
      simple resection of the primary tumor undergo exploratory surgery with extended regional
      lymph node dissection followed by observation.

      STRATUM III (stage III or IV disease):

      INDUCTION CHEMOTHERAPY: Patients receive cisplatin-based chemotherapy comprising oral
      mitotane four times daily on days 1-21; cisplatin IV over 6 hours on days 1-2; etoposide IV
      over 1 hour on days 1-3; and doxorubicin hydrochloride IV over 1 hour on days 4-5. Patients
      also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and
      continuing until blood counts recover OR pegfilgrastim SC once on day 6. Treatment repeats
      every 21 days for 2-4 courses in the absence of disease progression or unacceptable toxicity.
      Patients with stable disease or partial response proceed to surgery. Patients with a complete
      response proceed directly to continuation chemotherapy.

      SURGERY: Patients with stage III disease undergo extended surgery and regional lymph node
      dissection. Patients with stage IV disease undergo primary tumor resection (if feasible) with
      regional lymph node dissection and resection of the metastases. Patients then proceed to
      continuation chemotherapy.

      CONTINUATION CHEMOTHERAPY: Patients receive additional cisplatin-based chemotherapy (as in
      induction chemotherapy) for 4-6 courses followed by mitotane alone for an additional 2
      months. Patients with stage IV disease then proceed to additional surgery when feasible.

      ADDITIONAL SURGERY: Patients with stage IV disease may undergo additional primary tumor
      resection with regional lymph node dissection and resection (or re-resection) of the
      metastases.

      After completion of study treatment, patients are followed periodically for at least 5 years.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Five Year Event-free Survival (EFS)

Secondary Outcome

 Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Condition

Stage I Adrenocortical Carcinoma

Intervention

doxorubicin hydrochloride

Study Arms / Comparison Groups

 Stratum I (surgery, observation)
Description:  Patients undergo conventional surgery (primary tumor resection and retroperitoneal lymph node sampling) followed by observation. Patients who have undergone prior surgery without nodal sampling undergo observation only.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

78

Start Date

September 18, 2006


Primary Completion Date

December 31, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed adrenocortical carcinoma

               -  Newly diagnosed disease within the past 3 weeks

               -  Any disease stage allowed

          -  Lansky performance status 60-100% (for patients ≤ 16 years old)

          -  Karnofsky performance status 60-100% (for patients > 16 years old)

          -  Absolute neutrophil count ≥ 750/mm^3

          -  Platelet count ≥ 75,000/mm^3

          -  Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum
             creatinine based on age as follows:

               -  0.4 mg/dL (1 month to < 6 months)

               -  0.5 mg/dL (6 months to < 1 year of age)

               -  0.6 mg/dL (1 to < 2 years of age

               -  0.8 mg/dL (2 to < 6 years of age)

               -  1.0 mg/dL (6 to < 10 years of age)

               -  1.2 mg/dL (10 to < 13 years of age)

               -  1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

               -  1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT < 2.5 times ULN

          -  Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide
             angiogram

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No previous chemotherapy for adrenocortical carcinoma
      

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

Carlos Rodriguez-Galindo, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00304070

Organization ID

ARAR0332

Secondary IDs

NCI-2009-00413

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Carlos Rodriguez-Galindo, Principal Investigator, Children's Oncology Group


Verification Date

November 2016