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NCT00068406 · REGISTRY CONDITION SEARCH

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-11-20

This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Clinical and Pathologic Response

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outcome · POSTED

Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Diagnosis of locally advanced squamous cell carcinoma of the vulva * T3 or T4 (N0-3, M0) * Not amenable to surgical resection by standard radical vulvectomy * Previously untreated disease * No recurrent disease * No vulvar melanoma or sarcoma * Performance status - GOG 0-3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times normal * Alkaline phosphatase no greater than 3 times normal * SGOT no greater than 3 times normal * Creatinine no greater than 2.0 mg/dL * No gastrointestinal bleeding * No severe gastrointestinal symptoms * Capable of tolerating a radical course of chemoradiotherapy * No septicemia * No severe infection * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No circumstance that would preclude study completion or follow-up * No prior cytotoxic chemotherapy * No prior pelvic radiotherapy * No concurrent boost brachytherapy * No prior anticancer therapy that would contraindicate study therapy
healthy Volunteers
false
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity. Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Drug: Cisplatin
    3. Procedure: Conventional Surgery
    label
    Treatment (conventional surgery, radiation therapy, cisplatin)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (conventional surgery, radiation therapy, cisplatin)
    name
    3-Dimensional Conformal Radiation Therapy
    other Names
    1. 3-dimensional radiation therapy
    2. 3D CONFORMAL RADIATION THERAPY
    3. 3D CRT
    4. 3D-CRT
    5. Conformal Therapy
    6. Radiation Conformal Therapy
    type
    RADIATION
  2. arm Group Labels
    1. Treatment (conventional surgery, radiation therapy, cisplatin)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Treatment (conventional surgery, radiation therapy, cisplatin)
    name
    Conventional Surgery
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
61
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.
    measure
    Complete Clinical and Pathologic Response
    time Frame
    Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.
  2. description
    Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0
    measure
    Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
    time Frame
    Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment
Full study description
brief Summary
This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.
detailed Description
OBJECTIVES: I. Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy. II. Determine the toxicity of this regimen followed by surgery in these patients. OUTLINE: This is a multicenter study. Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity. Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
      NCT00068406
      primary nct id
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      source kind
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      source record id
      Source null
      source file sha256
      9c84fe83f9fcdb12f3a6bb624863442db2afcee53df61c38a03e4f013f7f76a1
      payload sha256
      1ceb2e84a099a6f36a959e0b61d7e1f6374989544595efaebda47429fd9e1db4
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e2752d4fd1b9f6c673a8
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT00068406
        end
        11
        exact text
        NCT00068406
        start
        0
      offset unit
      unicode_code_points
      query cond
      Vulvar Cancer
      query disease state id
      ds-vulvar-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vulvar-cancer-000.json
      source file sha256
      9c84fe83f9fcdb12f3a6bb624863442db2afcee53df61c38a03e4f013f7f76a1
      source json pointer
      /studies/9/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      0c8c7237b4558ba6582aea24989dd089176551263c6d2a50a6fd59b90fd670c2

    Preserved source evidence · Not medical advice