Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

Last updated: November 5, 2024
Sponsor: University of California, San Diego
Overall Status: Completed

Phase

2/3

Condition

Cervical Cancer

Pelvic Cancer

Vaginal Cancer

Treatment

IMRT

PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)

Cisplatin

Clinical Study ID

NCT01554397
INTERTECC
R21CA162718-01
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). The hypothesis is that PET-guided Bone Marrow Sparing IMRT will reduce acute hematologic and gastrointestinal toxicity and increase chemotherapy tolerance for cervical cancer patients treated with concurrent cisplatin.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamouscarcinoma of the cervix

  • Biopsy result positive for carcinoma within 60 days prior to registration

  • FIGO clinical stage I-IVA disease, based on standard diagnostic workup,including:History/physical examination and/or Examination under anesthesia (ifindicated)

  • If the patient is status post hysterectomy, one or more of the following conditionsmust be present: positive lymph nodes, positive margins, parametrial invasion, ornon-radical surgery (i.e., simple hysterectomy).

  • If the patient is inoperable, one or more of the following conditions must bepresent: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozensection, and/or parametrial invasion

  • Within 42 days prior to registration, the patient must have any of the following, ifclinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigidproctoscopy, or colonoscopy.

  • X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior toregistration;

  • CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;

  • Karnofsky Performance Status 60-100

  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3;Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention toachieve Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin < 1.5 mg/dl; WBC ≥ 3,000/μl; ALT/AST < 3 x ULN; INR ≤ 1.5

  • Negative serum pregnancy test for women of child-bearing potential

Exclusion

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer), unless disease freefor a minimum of 3 years;

  • Prior systemic chemotherapy within the past three years

  • Prior radiotherapy to the pelvis or abdomen that would result in overlap ofradiation therapy fields;

  • Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvicnodal metastasis is defined as either: Radiographic evidence of nodal metastasis onCT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodalmetastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake asdetermined and documented by the radiologist)OR Biopsy-proven metastasis (e.g.needle biopsy) in undissected node

  • Distant metastasis

  • Unstable angina and/or congestive heart failure requiring hospitalization within thepast 6 months

  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

  • Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any ofthe patient's physicians requires an immediate change in management;

  • Uncompensated heart disease or uncontrolled high blood pressure

  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition

Study Design

Total Participants: 101
Treatment Group(s): 3
Primary Treatment: IMRT
Phase: 2/3
Study Start date:
October 13, 2011
Estimated Completion Date:
January 01, 2022

Study Description

Multiple randomized controlled trials have established concurrent cisplatin-based chemoradiotherapy as the standard of care for locally advanced cervical cancer [3-8]. The addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic, could mitigate this toxicity and take advantage of the therapeutic benefits of intensive concurrent chemotherapy.

Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from conventional techniques in many ways. First, patients undergo computed tomography (CT) simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment planning involves multiple beam angles and uses computerized inverse treatment planning optimization algorithms to identify dose distributions and intensity patterns that conform dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is typically accomplished with the use of multileaf collimators, which involve small motorized leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.

PET-guided Bone Marrow Sparing IMRT is designed to spare hematopoietically active subregions of the pelvic bone marrow using quantitative image segmentation. Previous studies indicate this approach can reduce toxicity and improve chemotherapy tolerance, which may improve outcomes and help optimized delivery of cytotoxic chemotherapy.

Connect with a study center

  • Xijing Hospital

    Xi'an, 710032
    China

    Site Not Available

  • University Hospital Hradec Králové

    Hradec Králové,
    Czech Republic

    Site Not Available

  • University Hospital Hradec Králové

    Hradec Králové,
    Czechia

    Site Not Available

  • Tata Memorial Hospital

    Parel, Mumbai 400 012
    India

    Site Not Available

  • Asan (Hyundai) Medical Center

    Songpa-Gu, Seoul
    Korea, Republic of

    Site Not Available

  • Marie Sklodowska Cancer Center

    Gliwice,
    Poland

    Site Not Available

  • Far Eastern Memorial Hospital

    Pan-Chiao, Taipai 220
    Taiwan

    Site Not Available

  • King Chulalongkorn Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Istanbul Bilim University

    Gayrettepe, Istabul 34340
    Turkey

    Site Not Available

  • Royal Surrey County Hospital

    Guildford, Surrey 7XX
    United Kingdom

    Site Not Available

  • Moores UC San Diego Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Moffitt Cancer Center and Research Institute, H. Lee Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Pittsburgh Cancer Center, UPMC

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

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